WEBVTT 1 00:00:00.040 --> 00:00:01.239 Monserrat Conde: To be cool. 2 00:00:02.520 --> 00:00:17.040 Monserrat Conde: Welcome to the tobacco online policy seminar tops. Thank you for joining us today. I'm Dr. Mosra Kant, a postdoctoral researcher at the University of Oxford Tops is organized by Mike Pesco, at the University of Missouri. 3 00:00:17.180 --> 00:00:30.909 Monserrat Conde: C. Cheng. At the Ohio State University, Michael Darden at at Johns Hopkins University, Jamie Artmont Boyce at University of Massachusetts, Farmers, and Justin White at Boston University. 4 00:00:31.130 --> 00:00:47.489 Monserrat Conde: The Seminar will be 1 h with questions from the Moderator and discussant. The audience may pose questions and comments in the Q. And a panel, and the moderator will draw from these questions and comments in conversation with the presenter. 5 00:00:47.530 --> 00:01:09.239 Monserrat Conde: Please review the guidelines on tobaccopolicy.org for acceptable questions. Please keep the questions professional and related to the research being discussed. Questions that meet the seminar series. Guidelines will be shared with the presenter afterwards, even if they are not read aloud. Your questions are very much appreciated. 6 00:01:09.470 --> 00:01:19.300 Monserrat Conde: This presentation is being video record and will be made available along with presentation slides on the tops website, tobaccopolicy.org. 7 00:01:19.580 --> 00:01:36.180 Monserrat Conde: We would like to take a moment to make a special announcement, a free webinar, entitled Challenges Regulating the Top. The tobacco industry will be hosted by John Hopkins University from 12 to one Pm. On Friday, January 24.th 8 00:01:36.410 --> 00:01:46.770 Monserrat Conde: This event is moderated by tops. Executive board. Member, Dr. Michael Darden. Please see this the chat for more information and the registration. URL. 9 00:01:47.370 --> 00:01:48.530 Monserrat Conde: I will 10 00:01:48.680 --> 00:01:56.699 Monserrat Conde: turn the presentation over to today's moderator, Jamie Artman Boyce, from the University of Massachusetts, armist, to introduce our speaker. 11 00:01:57.080 --> 00:02:26.530 Jamie Hartmann-Boyce: Thanks so much, milsera, and thanks all of you for being here today before we continue with today's seminar, we'd like to take a moment to recognize the winner of the best tops. Presentation of 2024. This year's award goes to Nancy Rigotti for her outstanding presentation. Cytosine for tobacco cessation, recent studies, and next steps for a new and old drug congratulations. Dr. Rigotti. If we were in person I would shake your hand. But I wondered, since you are joining us, if you'd like to, at least give us a wave. 12 00:02:27.520 --> 00:02:32.229 Nancy Rigotti: Thank you so much. It's a great honor, and I very much enjoy these seminars. 13 00:02:32.420 --> 00:02:42.030 Jamie Hartmann-Boyce: Wonderful. Thank you so much, Nancy, and for anyone who's interested but missed that seminar. There's a link to the recording in the chat. Now, thank you, Nancy, and congratulations. 14 00:02:43.460 --> 00:03:04.359 Jamie Hartmann-Boyce: So today we continue our winter. 2025, season with a single paper presentation by Dana Miles Carroll, entitled Very Low nicotine content cigarettes in the context of non-combusted nicotine products, findings and implications for public health policy. This presentation was selected by a competitive review process by submission through the Tops website. 15 00:03:04.570 --> 00:03:23.769 Jamie Hartmann-Boyce: Dana Carroll, Md. Mph. Is an epidemiologist and certified tobacco treatment specialist. She was recently awarded the early Career Investigator award from the National Institute on Minority, health and Health Disparities, as well as the Jarvik Russell Award, which is an early career investigator, award from the Society for Research on Nicotine and tobacco. 16 00:03:23.920 --> 00:03:48.689 Jamie Hartmann-Boyce: Her program of research has evolved from mainly describing commercial tobacco, use patterns and risk factors via large-scale epidemiologic studies to also addressing commercial tobacco use via clinical trials related to her tops presentation. She's interested in the impact of potential cigarette product standards and was a postdoctoral fellow and later a co-investigator with the center for evaluation of nicotine and cigarettes at the University of Minnesota. 17 00:03:49.360 --> 00:04:01.870 Jamie Hartmann-Boyce: Dr. Dorothy Hatsukami, a professor of psychiatry and Behavioral Sciences at the University of Minnesota, is senior author of the Studies, and will answer select questions in the Q. And A. Dr. Carroll thanks so much for presenting for us today. 18 00:04:07.220 --> 00:04:12.350 Dana Carroll: Great. Thank you so much for having me, and let me get my slides up. 19 00:04:16.690 --> 00:04:22.139 Dana Carroll: Okay, hopefully, this is showing. Well, Jamie, just let me know if that's not the case. 20 00:04:22.250 --> 00:04:42.930 Dana Carroll: So I am thrilled to be here today from snowy Minnesota, as mentioned, I am Dana Carroll, and I'm an associate professor in the School of Public Health, and I'm going to be talking to you today about very low nicotine, content cigarettes, which is quite timely given the past couple weeks with the potential product standard being in the news. 21 00:04:45.340 --> 00:04:54.819 Dana Carroll: So here are my disclosures. This research that I'm presenting today was funded by the Nih, and there are no tobacco related industry sources of funding. 22 00:04:56.820 --> 00:05:14.690 Dana Carroll: So nicotine. And why are we focusing on very low nicotine cigarettes? Nicotine is the primary psychoactive constituents constituent of cigarette smoke, and is responsible for smoking reinforcement independence. And this quote here, I thought, really encapsulated the role of nicotine. 23 00:05:14.910 --> 00:05:27.660 Dana Carroll: It was by Philip Morris in 1972. The cigarette should be conceived, not as a product but as a package. The product is nicotine. And think of the cigarette pack as a storage container for a day's supply of nicotine 24 00:05:27.920 --> 00:05:30.440 Dana Carroll: won't read all of it, but I think that conveys 25 00:05:30.560 --> 00:05:34.669 Dana Carroll: the the role of nicotine in smoking. 26 00:05:36.770 --> 00:05:59.680 Dana Carroll: so reducing nicotine and cigarettes is not a new idea, and around that it could potentially reduce the addictiveness and facilitate smoking cessation. Really, this idea came from Neil Benowitz and Jack Henningfield in the 19 nineties, and they published their thoughts in this commentary in the New England Journal of Medicine. 27 00:05:59.690 --> 00:06:07.659 Dana Carroll: and I actually learned from Jack that they decided to bring this up and think about this on a jog during a conference. 28 00:06:07.710 --> 00:06:12.330 Dana Carroll: So it means that conference breaks can prove to be fruitful. 29 00:06:14.460 --> 00:06:38.010 Dana Carroll: So today's research and the results I'm going to be talking to you about have really come after a lot of milestones in the field. And I wanted to review those just in a nutshell as best as I could today, so that I can catch some of you folks up to speed who might not be as familiar as others. 30 00:06:38.400 --> 00:06:54.659 Dana Carroll: So certainly the family smoking Prevention Tobacco Control Act of 2,009, which provides the FDA. The regulatory authority over tobacco products was critical in ensuring the standard can progress, at least in the United States. 31 00:06:54.830 --> 00:07:02.620 Dana Carroll: and one of the stipulation in this act was that nicotine content in commercially available cigarettes could be reduced 32 00:07:02.750 --> 00:07:08.660 Dana Carroll: to low levels as long as that was non-zero for the protection of public health. 33 00:07:08.860 --> 00:07:21.630 Dana Carroll: And so since then there have been numerous studies that have sought to answer this question, the what, the why, the how can nicotine be reduced in cigarettes for the protection of public health? 34 00:07:22.210 --> 00:07:35.099 Dana Carroll: And many of these studies have come out of the center for evaluation of nicotine and cigarettes, although there's certainly been others. For example, the Vermont tea course has been a powerhouse in this area as well. 35 00:07:35.350 --> 00:07:56.040 Dana Carroll: and these studies have contributed to a strong evidence base. That shows that if we reduce nicotine levels in cigarettes to very low compared to our normal nicotine cigarettes on the marketplace. These low nicotine cigarettes can reduce cigarettes per day and facilitate smoking cessation 36 00:07:56.500 --> 00:08:14.159 Dana Carroll: results from the scenic studies helped us understand. So what level is it that we need to reduce nicotine in cigarettes and a threshold of 0 point 4 milligrams of nicotine was shown to be most optimal, and that's in a 2015 study. 37 00:08:14.430 --> 00:08:38.940 Dana Carroll: Subsequently there was a study that looked at a question. Should nicotine be immediately reduced? For example, a set date, or gradually over time, and the results of that study showed that an immediate reduction in nicotine and cigarettes would be most optimal in terms of reducing biomarkers of exposure and harm among people who smoke. 38 00:08:39.580 --> 00:08:48.749 Dana Carroll: Although it doesn't show this in this slide. I do want to share that there's been several modeling studies that have really shown the potential groundbreaking impact of this standard. 39 00:08:48.950 --> 00:08:52.560 Dana Carroll: And in fact, there's a 2021 modeling study that showed 40 00:08:52.790 --> 00:09:10.580 Dana Carroll: based on this evidence base and a expert panel that informed them that if this standard were to be implemented and importantly, all cigarettes commercially available in the United States would be very low nicotine 41 00:09:10.790 --> 00:09:20.959 Dana Carroll: up to 60% of people who smoke would quit within the 1st year, and an estimated 8.5 million tobacco caused deaths would be averted by 2,100. 42 00:09:21.100 --> 00:09:34.279 Dana Carroll: Now time has passed since that modeling, and so there's been deaths not averted that being said, the impacts of this standard are quite, you know, very high potential. 43 00:09:35.780 --> 00:09:45.190 Dana Carroll: You may know that New Zealand moved forward for a bit with passing this policy, but then it was not fully, I should say it wasn't fully passed. 44 00:09:45.250 --> 00:10:08.160 Dana Carroll: but that was a lot of buzz that was exciting and thinking about this policy being passed around the world. And most recently in the United States, there's been a lot of buzz in the news around the nicotine reduction standard moving to the next stage in rulemaking with the office of measurement and budget which it just cleared and means it's moving on to a notice of proposed rulemaking 45 00:10:08.160 --> 00:10:23.080 Dana Carroll: just this past week or 2, and so there are several other steps in this rulemaking process. But this momentum is quite exciting for those that have been involved in these studies, and certainly the news has been picking up on this as well. 46 00:10:23.670 --> 00:10:30.489 Dana Carroll: So I will say, while experimentally strong and important for establishing the foundation 47 00:10:30.610 --> 00:10:48.469 Dana Carroll: for this potential policy. Most of these prior studies provided strict instructions to participants to only smoke their assigned cigarette, which was either the normal nicotine content, cigarettes, or very low nicotine content cigarettes. 48 00:10:48.750 --> 00:11:18.239 Dana Carroll: We know that's not the real world. So there is a diversity of nicotine and tobacco products available to consumers. And so showing in this type of environment that a nicotine standard is still beneficial over the status quo of having a diverse amount of products is certainly an important research question that needs to be further addressed and has been looked at in some more of the recent studies. 49 00:11:19.050 --> 00:11:25.909 Dana Carroll: And, in fact, one of those studies I'm going to talk to you about today is what has become coined the marketplace study. 50 00:11:26.070 --> 00:11:43.940 Dana Carroll: So this study, as you can see here, involved several folks from around the United States, and was a pretty tremendous effort. It ended up being a 6 Site Clinical Trial Recruiting People who smoke and was published in 2024 in the Lancet. 51 00:11:45.460 --> 00:11:48.429 Dana Carroll: and this is the one I'm going to do a deeper dive on. 52 00:11:48.980 --> 00:12:00.729 Dana Carroll: So what was the objective of this study? Although you probably can gleam glean where I'm going. It's really to examine the effects of that very low nicotine content cigarette. 53 00:12:00.910 --> 00:12:20.080 Dana Carroll: An attempt to mimic the nicotine standard versus a normal nicotine content cigarette that you would find in the stores today on smoking behavior and biomarkers of exposure in this experimental marketplace that we try to reflect the real world with noncombustible tobacco products. 54 00:12:20.540 --> 00:12:25.659 Dana Carroll: In other words, somebody might say, well, mimicking a nicotine standard, reduce 55 00:12:25.760 --> 00:12:30.720 Dana Carroll: smoking when compared with the status quo diverse marketplace. 56 00:12:30.970 --> 00:12:41.800 Dana Carroll: And I think this is an important way to look at this question, because often I have been asked, why not just let the marketplace and a variety of products available help 57 00:12:41.910 --> 00:12:47.709 Dana Carroll: people switch to less harmful products. If there's e-cigarettes, nicotine pouches, they'll gravitate to those products. 58 00:12:47.950 --> 00:12:52.919 Dana Carroll: And so I think this really sets us up to answer this question. 59 00:12:53.990 --> 00:13:09.300 Dana Carroll: So I'm just going to briefly go over the methods. And I have actually one more slide on the methods after this. And then we're going to take a pause to see if folks have any questions about the methodology or any of the past studies that I mentioned. 60 00:13:09.710 --> 00:13:19.259 Dana Carroll: So on your left. You can see the eligibility. Nothing too surprising. What we tried to do is recruit the general population of people who smoke. 61 00:13:19.530 --> 00:13:34.760 Dana Carroll: They had to have stable mental physical health. And importantly, we did allow other tobacco and nicotine product use, because many smokers do not just smoke, but use other products. And so that's an important note on our eligibility 62 00:13:35.360 --> 00:13:43.449 Dana Carroll: in total. There were 3 phases of this study that ran from 2,018 to 2022. 63 00:13:43.610 --> 00:14:07.030 Dana Carroll: The 1st phase was really just baseline monitoring. So after they were consented, we essentially let them go back out into the rural world, and they completed daily phone calls on their tobacco use. So we knew what their baseline use patterns were. So if, for example, they were also using an e-cigarette at Baseline, we got that information as well. 64 00:14:07.250 --> 00:14:15.910 Dana Carroll: and this also showed us if they were compliant to using the daily phone call and could be further considered for the study 65 00:14:16.320 --> 00:14:23.450 Dana Carroll: phase 2 is where we exposed folks to our experimental marketplace, and I'll show this on the next slide. 66 00:14:23.770 --> 00:14:34.940 Dana Carroll: And essentially what this goal was to maintain access to their usual brand cigarette. So if they were, in phase one smoking Marlboro Reds 67 00:14:35.080 --> 00:14:51.160 Dana Carroll: in Phase 2. They got access to our experimental marketplace that had their Marlboro reds, but also a variety of non-combusted tobacco products that reflect the non-combustible tobacco products in the world world. 68 00:14:51.850 --> 00:15:06.590 Dana Carroll: After 2 weeks of access to that, that is, when we then randomized them, and so they were either randomized to very low nicotine, spectrum cigarettes or normal nicotine spectrum cigarettes. 69 00:15:06.820 --> 00:15:15.290 Dana Carroll: They got access to the other tobacco products, and we continue to monitor them in their use, behavior and biomarkers for 12 weeks. 70 00:15:17.310 --> 00:15:33.129 Dana Carroll: So the marketplace to me this was a really fun concept that I was able to work on as a postdoc, and actually was able to take a trip out to the recently passed Dr. Warren Bickles Lab to learn about his use of a marketplace in studies. 71 00:15:33.600 --> 00:15:47.609 Dana Carroll: And so, as you see here, what we were trying to do, and this is actually a screenshot of a marketplace where participants would access on a laptop in the clinic, or virtually. 72 00:15:47.770 --> 00:16:00.860 Dana Carroll: and they would be able to see the products that they had access to in this study. If this was phase, 2 participants would click on the cigarettes, and it would they could purchase cigarettes with points. 73 00:16:01.070 --> 00:16:04.820 Dana Carroll: and I can talk to you a little bit about what those points look like in a minute. 74 00:16:05.170 --> 00:16:17.619 Dana Carroll: and if they purchase cigarettes, then they actually were provided their usual brand, and that was either if they were already in person, or they came by for a curbside visit. We actually gave them their cigarettes. 75 00:16:17.790 --> 00:16:25.710 Dana Carroll: If this was during the intervention period, those cigarettes were either the very low nicotine content cigarettes or the normal nicotine content cigarettes. 76 00:16:25.990 --> 00:16:33.459 Dana Carroll: They could also navigate to a page with the vaping devices and check those out. And you can see some of these other products. 77 00:16:33.840 --> 00:16:48.760 Dana Carroll: So just to try to be as brief as possible. The goal of this marketplace was to have products that had the greatest market share. So for the tobacco products, the vaping, the smokeless tobacco, and the nicotine pouches. We actually went out to sites 78 00:16:48.930 --> 00:17:02.260 Dana Carroll: at each retail outlets at each of the sites, and had conversations with the retail locations, the vape shops, and to understand what was the highest market share of products. 79 00:17:02.400 --> 00:17:16.679 Dana Carroll: We did this every year and updated the marketplace, and so it became soon called the complicated marketplace, but it allowed us to evolve as the marketplace evolved in the real world, which I think is a huge asset of the study. 80 00:17:17.069 --> 00:17:19.679 Dana Carroll: For example, nicotine pouches were not 81 00:17:20.079 --> 00:17:31.550 Dana Carroll: the time of the beginning of the study available at the sites, but then, I believe, about halfway through became available, and so we introduced those into the marketplace for participants to choose from. 82 00:17:32.450 --> 00:17:34.829 Dana Carroll: and as a quick comment on points. 83 00:17:34.960 --> 00:17:41.469 Dana Carroll: participants were provided, points that reflected their baseline cigarette and other tobacco product use 84 00:17:41.850 --> 00:18:05.979 Dana Carroll: with the idea that they could use those points to exchange for these products. So, for example, if somebody was smoking about a pack a day and that was it, they would get a certain amount of points. If somebody was packing, smoking 2 packs a day, they would get double those points, and we also gave some additional points to each participant to allow for experimentation which we expect to occur in the real world as well. 85 00:18:07.150 --> 00:18:12.390 Dana Carroll: And with that I am going to pause for questions on the methodology. 86 00:18:13.010 --> 00:18:22.750 Jamie Hartmann-Boyce: Thank you so much, Dana, for that brilliant introduction. So audience members, if you have questions, please do share them via the Q. And a function. But the 1st thing I'd like to do during this 87 00:18:22.860 --> 00:18:43.610 Jamie Hartmann-Boyce: break is turn over to our discussant. So we're lucky today to be joined by Dr Justin Byron as our discussant, who's an associate professor at the University of North Carolina School of Medicine. His research area is in advancing communication, science and Tobacco control, and addressing misperceptions about very low nicotine cigarettes. Dr. Byron, over to you. 88 00:18:44.790 --> 00:18:47.868 Justin Byron: Thank you. Yeah. Excellent presentation so far, Dana. 89 00:18:48.673 --> 00:19:04.760 Justin Byron: I think you really explained all the thought and hard work that went into designing the study. I guess one question I had based on what you presented so far was, if Icos was on the market during some of the time of study in some of these locations, and whether you all considered, including that as one of the products. 90 00:19:05.610 --> 00:19:30.779 Dana Carroll: Yeah, thank you. We certainly monitored it as part of our surveillance efforts, but it never entered. You know many of the retail outlets that our participants resided in. So we kept a eye toward the device, the heat not burned devices, but at the time of the study it was not included. For that reason, I think if that study was implemented today, it certainly would be. 91 00:19:31.720 --> 00:19:32.320 Justin Byron: Thank you. 92 00:19:35.170 --> 00:19:38.550 Jamie Hartmann-Boyce: That it from you, Justin? Or is there anything else you'd like to ask at this point. 93 00:19:38.790 --> 00:19:40.200 Justin Byron: That's all I have for now. 94 00:19:40.200 --> 00:19:49.519 Jamie Hartmann-Boyce: Great. And Dana, we have one question from an audience member, one of the eligibility criteria was stable, mental and physical health. Would you be able to share how that was assessed. 95 00:19:50.000 --> 00:20:08.760 Dana Carroll: Yeah. Yeah. So participants came in and they completed a pretty extensive medical history. We do have licensed medical providers who review that history with us, and so that the idea was really, if they had any comorbid health conditions they were. They were stable. 96 00:20:08.910 --> 00:20:19.589 Dana Carroll: and you know, I think a big one that comes up a lot is high blood pressure, and so if we detected they were on high blood, they had high blood pressure. They were not eligible for the study. 97 00:20:20.440 --> 00:20:34.489 Jamie Hartmann-Boyce: Great. Thank you, Dana. And now I have 2 questions that have come in around the points in baseline tobacco. Use behavior. So how did you calculate the equivalence of E-liquid snooze and pouches to the number of cigarettes smoked. 98 00:20:35.160 --> 00:21:01.100 Dana Carroll: Yes, this is a really good question. I'll start off by saying that the point calculation was the same across, you know, both arms. And so that's that's important to note in a clinical trial, you know, we put a lot of thought into this. And so what we were able to do is actually try and find the points were really all based on a cigarette unit. And so what we tried to do is make 99 00:21:01.430 --> 00:21:09.100 Dana Carroll: e-cigarette liquid based on the nicotine level equivalent on a cigarette basis and calculate the points that way. 100 00:21:09.703 --> 00:21:19.940 Dana Carroll: It is much more complicated than that. I'd be happy to share our our math with you. But we did look at the literature and tried our best 101 00:21:20.190 --> 00:21:29.579 Dana Carroll: to convert these products to a similar unit of nicotine. And then based on that nicotine provide points, but it certainly was 102 00:21:29.830 --> 00:21:50.040 Dana Carroll: more complicated than that, you know. So, for example, if somebody was doing had, for some reason at Baseline a piece of nicotine gum. That was 2 milligrams a day, and then somebody had a piece of nicotine gum. That was 4 milligrams a day. They would get more points based on the higher nicotine. 103 00:21:50.580 --> 00:21:52.410 Dana Carroll: I'll also say 104 00:21:52.660 --> 00:22:04.039 Dana Carroll: one of the things that we thought through was the challenge that the e-cigarette devices and the nicotine replacement therapy is just more expensive to buy into than 105 00:22:04.230 --> 00:22:12.060 Dana Carroll: a pack of cigarettes. And so if they did want to experiment or uptake those products. There was a single use coupon 106 00:22:12.230 --> 00:22:27.289 Dana Carroll: to get that device, and then after that it was getting the E-liquid or the pods for it. So again, that was on both arms that option, but we did think that through a bit as well. 107 00:22:28.100 --> 00:22:37.120 Jamie Hartmann-Boyce: Great thanks, and did participants know in advance that their baseline tobacco use behavior would determine how many points they would earn in the follow up phases. 108 00:22:37.120 --> 00:22:52.759 Dana Carroll: No, they did not. Yep, and we we but we encourage truthful reporting, and let them know that if they are using any cigarette that won't make them ineligible. We just want to know their honest reporting during baseline, so we can take that into consideration. 109 00:22:53.210 --> 00:23:07.679 Jamie Hartmann-Boyce: Great thanks, and I'll ask one last question before we move on in the interest of time. So just a follow up question on the point system was any consideration given to different forms of nicotine across different products? For example, nicotine salts versus freebase nicotine. 110 00:23:09.426 --> 00:23:10.533 Dana Carroll: That's a good question, 111 00:23:10.930 --> 00:23:13.590 Dana Carroll: and I no, there was not. 112 00:23:13.750 --> 00:23:18.610 Dana Carroll: Yeah. I mean the so to clarify, though 113 00:23:19.290 --> 00:23:23.330 Dana Carroll: the devices were priced in our marketplace 114 00:23:23.570 --> 00:23:30.120 Dana Carroll: at a level that Ref. So, for example, we had jewel, and then we had views 115 00:23:30.220 --> 00:23:46.420 Dana Carroll: and some others. Juul was more expensive than views. So jewel was more expensive in our marketplace, based on how much more expensive it was in the sites. So again, the relative difference of all these products was site specific and trying to be real world. 116 00:23:46.978 --> 00:23:54.940 Dana Carroll: But then the points that participants got did not take into account, you know, at baseline anything beyond nicotine level. 117 00:23:56.000 --> 00:23:58.510 Jamie Hartmann-Boyce: Thanks so much. That is a lot of complexity to be. 118 00:23:58.510 --> 00:23:59.070 Dana Carroll: It is. 119 00:23:59.350 --> 00:24:02.719 Jamie Hartmann-Boyce: And we are excited to hear what you've found. So do go. 120 00:24:02.720 --> 00:24:05.250 Dana Carroll: Okay, alright, great. 121 00:24:05.510 --> 00:24:11.599 Dana Carroll: Yeah. I I expected those questions. So I hopefully provide some clarity. 122 00:24:12.020 --> 00:24:27.329 Dana Carroll: So what did we find? So cigarettes per day were our primary endpoint, and the blue is the low nicotine, content condition, and the red is the normal nicotine content condition. And you see, they're starting just quickly after they were 123 00:24:27.500 --> 00:24:49.669 Dana Carroll: exposed to the very low or normal nicotine cigarettes after phase 2. That we saw a difference that was significant. Towards the end of the study as well. I think this slide already starts to answer whether the status quo tobacco marketplace, with the diversity of tobacco products, is sufficient for helping reduce smoking. 124 00:24:50.130 --> 00:24:54.580 Dana Carroll: and I think the answer looks like it's not the case compared to a nicotine standard. 125 00:24:56.830 --> 00:25:23.620 Dana Carroll: Urinary. Sema. This is a biomarker. I think that's 1 of the important things that we did in this study was not just look at use behaviors, but biomarkers of exposure and effect as well. And so Sema is a biomarker for smoke exposure. It's a biomarker for acryla nitrile, which is a volatile organic compound, and you see similar relationship where the low nicotine content condition declined 126 00:25:23.720 --> 00:25:29.259 Dana Carroll: pretty quickly after randomization and sustained to the end of the study. 127 00:25:31.340 --> 00:25:39.199 Dana Carroll: We also looked at smoking abstinence, which is really really helpful. That's the goal right to get folks to to quit smoking. 128 00:25:39.340 --> 00:25:52.759 Dana Carroll: and you'll see that the very low nicotine content group starting around the week, 4 intervention had a higher smoking abstinence that continued to the end of the study. 129 00:25:52.930 --> 00:26:01.279 Dana Carroll: I will also say that those who achieved abstinence, the majority actually specifically 81% in the low nicotine group. 130 00:26:01.430 --> 00:26:13.339 Dana Carroll: We're using alternative nicotine delivery systems that actually includes all of the products. But if you looked at it, it's in large part driven by e-cigarette use. 131 00:26:17.030 --> 00:26:23.070 Dana Carroll: Okay, this is the last slide of the main results that I'll show you. And then we can pause. 132 00:26:23.390 --> 00:26:45.829 Dana Carroll: And so these are the patterns of use, your low nicotine content group is on your left. The normal nicotine content group is on your right, and the blue line represents combusted tobacco. Use. The orange line is dual use. So those folks are going to be using. You know, their study cigarette and one or more of the non-combusted products. 133 00:26:45.830 --> 00:26:57.059 Dana Carroll: And the green line is no use of combusted products, and that includes both use of only non combusted products or no use of products at all. 134 00:26:57.330 --> 00:27:03.350 Dana Carroll: And so we see in the low nicotine content group, lower combusted tobacco use 135 00:27:03.520 --> 00:27:06.259 Dana Carroll: in higher dual use in the initial weeks. 136 00:27:06.440 --> 00:27:16.370 Dana Carroll: But in later weeks, non-used of combusted tobacco, which is that green line that starts to creep up there increase in the low nicotine content condition. 137 00:27:16.620 --> 00:27:23.920 Dana Carroll: and that as well. Dual use more closely started to resemble the levels in the normal nicotine content condition. 138 00:27:24.080 --> 00:27:25.080 Dana Carroll: So 139 00:27:25.190 --> 00:27:32.619 Dana Carroll: it was helpful to see these patterns that really correspond with the the reduction in the biomarkers that we saw. 140 00:27:32.740 --> 00:27:42.539 Dana Carroll: I think another take home from this slide is a nicotine trying to mimic a nicotine standard. It's not likely to be a silver bullet. So many folks 141 00:27:42.650 --> 00:27:49.550 Dana Carroll: continued smoking either exclusively or dual use. And so we can talk about the implications of that in a bit. 142 00:27:51.820 --> 00:27:54.439 Dana Carroll: And I have another pause for questions. 143 00:27:54.590 --> 00:28:00.380 Jamie Hartmann-Boyce: Wonderful. So 1st over to our discussant, Dr. Byron, to see if you have any questions at this point. 144 00:28:00.650 --> 00:28:21.140 Justin Byron: Yeah, just a little one. On the previous graph, you have what looks basically like an impressive line of the green line of people who have stopped using the combusted tobacco. And you note here that it's both people that have quit all tobacco and people that are maybe still using just e-cigarettes right non-combusted. Do you happen to know how much of that proportion was each. 145 00:28:22.460 --> 00:28:31.940 Dana Carroll: Yeah, I would. The answer is, yes. Do I know it off the top of my head? No, I do think it was majority non combusted 146 00:28:32.130 --> 00:28:36.200 Dana Carroll: tobacco product use versus no use at all. 147 00:28:36.600 --> 00:28:37.210 Justin Byron: Thank you. 148 00:28:37.490 --> 00:28:38.040 Dana Carroll: Yeah. 149 00:28:39.130 --> 00:28:54.850 Jamie Hartmann-Boyce: Thanks, and we have 2 questions in the Q&A. So the 1st one is about what motivated participants to join this study. If they weren't necessarily interested in quitting smoking was the sole motivation to obtain free products. And how might that affect generalizability of findings. 150 00:28:55.430 --> 00:29:14.339 Dana Carroll: Yeah, that's a great question. So we did not pitch this as a smoking cessation study. Some times we do pitch studies like that because we're looking for folks that are interested in quitting. So we took. And actually, majority of participants were not interested in quitting smoking immediately. 151 00:29:14.690 --> 00:29:21.360 Dana Carroll: We did pitch this, you know, incentives and the opportunity to try other tobacco products. 152 00:29:21.620 --> 00:29:26.539 Dana Carroll: But other than maybe an interest in research, an interest in incentive. 153 00:29:26.650 --> 00:29:31.979 Dana Carroll: You know, I can't speak. Beyond that, I will say we have looked at 154 00:29:32.240 --> 00:29:49.630 Dana Carroll: the generalizability of our participants compared to smokers, for example, in the Us. Representative path study, and they can be quite strikingly similar with regard to sociodemographic variables. So that 155 00:29:49.940 --> 00:30:03.260 Dana Carroll: gives me some, you know, satisfaction that you know this wasn't us representative. But our smokers are not just a kind of unique batch of of folks. 156 00:30:03.960 --> 00:30:17.609 Jamie Hartmann-Boyce: Great. Thank you. And I'm aware you might be coming onto this, in which case you can save your answer. But did you look at, and if so, were there any differences in results for people who might have been interested in quitting smoking versus those not interested. 157 00:30:17.900 --> 00:30:25.659 Dana Carroll: Hmm, I do not believe so, but I have Dorothy in the audience, so if she can 158 00:30:26.570 --> 00:30:31.790 Dana Carroll: see if if we looked at that. So that would be a really interesting moderator. Analysis. 159 00:30:32.254 --> 00:30:36.509 Dana Carroll: To see how those interested in quitting versus those that were not. 160 00:30:36.650 --> 00:30:42.710 Dana Carroll: that moderated the impact of the conditions on the outcomes. 161 00:30:43.360 --> 00:30:44.020 Jamie Hartmann-Boyce: Great. 162 00:30:44.330 --> 00:31:05.309 Jamie Hartmann-Boyce: Thank you. So next question, which I think you might have partly answered, already talking about the representativeness of your sample to what you saw on path was, is, were you all at all concerned that requiring urine samples might bias the participant group, for example, might a cannabis user be concerned that his or her cannabis use might be noticed, regardless of whether your test would catch it. They might be concerned. It would. 163 00:31:07.150 --> 00:31:13.099 Dana Carroll: Yeah, that's a good question. So we again, our sample looked quite 164 00:31:13.410 --> 00:31:37.450 Dana Carroll: generalizable to what we typically see with smokers. And now I'm thinking. Gosh! I should have had like a table one to show folks the descriptive characteristics. So I'll note that for next time. But you know I don't think we had. Certainly, if somebody didn't want to provide a urine sample, they would have, you know, not continued on the study. But 165 00:31:38.180 --> 00:31:41.079 Dana Carroll: I can't. I can't speak to to that. 166 00:31:42.420 --> 00:31:54.089 Jamie Hartmann-Boyce: Thank you. And last question for this round. Can you speak to compliance in the study? Do you have any sense of how many participants assigned to the Vlmc. Group used Nncs. Anyways. 167 00:31:54.430 --> 00:31:57.518 Dana Carroll: Yeah, that's a really good question. So 168 00:31:58.220 --> 00:32:14.290 Dana Carroll: for some context, the prior study that looked at immediate or and gradual reduction. If we looked in the immediate group, and that was a group that was assigned to low nicotine cigarettes and instructed to not use anything other than those products. 169 00:32:14.560 --> 00:32:30.140 Dana Carroll: the the noncompliance. So the use of normal nicotine cigarettes which they got out in the real world was around twice as much as it was in this study. So there still was noncompliance. 170 00:32:30.390 --> 00:32:40.730 Dana Carroll: Now, if the standard were implemented, the the smokers could not go to commercial outlets 171 00:32:40.880 --> 00:32:50.960 Dana Carroll: to get cigarettes with normal nicotine cigarettes and so I think it opens kind of a question of the illicit marketplace, and whether. 172 00:32:53.020 --> 00:33:10.080 Dana Carroll: which you know is has been expressed as a concern. But it was halved in the study. And that's really to the availability of the non-combusted tobacco products which reflects the real world. I think that could be further reduced 173 00:33:10.300 --> 00:33:27.669 Dana Carroll: in a scenario where health communications was provided, strongly encouraging smoking cessation kind of getting to some of my implications. But I also think that the FDA's strategic plan to educate smokers about the relative. 174 00:33:28.190 --> 00:33:46.589 Dana Carroll: The continuum of risk with tobacco products and the importance of complete switching could also help further reduce the noncompliance that we have seen, and even in the most recent study here, and it was about 2 cigarettes per day in the very low nicotine content group. 175 00:33:47.260 --> 00:33:50.669 Jamie Hartmann-Boyce: Great. Thank you so much. On to your next section. 176 00:33:51.160 --> 00:33:51.700 Dana Carroll: Hey? 177 00:33:54.030 --> 00:34:10.039 Dana Carroll: Great? So some of the additional key questions that were asked as part of this effort was one ones that I think really pertain to health equity, so will certain groups of people who smoke benefit less so than others. 178 00:34:10.250 --> 00:34:20.120 Dana Carroll: and I'll tell you in a second. But what we did is at least with today's presentation and focusing on age, educational attainment and racial identity. 179 00:34:20.420 --> 00:34:43.239 Dana Carroll: And I think this photo here just puts into perspective why we are interested in moderation. So I think there are more and more studies looking at heterogeneity in effect. And that's because what works for some or all might not work for others. And so, while we see a positive effect from the low nicotine cigarettes. 180 00:34:43.510 --> 00:34:54.229 Dana Carroll: conditions across these studies is that the case when we look within certain groups. And for me, it's really an interest in looking in groups who have typically 181 00:34:54.510 --> 00:35:10.659 Dana Carroll: had the greatest burden due to smoking and so ensuring that potentially, if we need to find greater nudges so that they can catch up making sure the benefits are positive, like we see in the overall study, for example. 182 00:35:11.640 --> 00:35:31.670 Dana Carroll: So I already shared this. It really provides a health equity lens. And we focused on older, really older age versus younger adults as well as lower education. And that's because these 2 groups have had either stagnant or more slowly declining smoking prevalences. 183 00:35:31.840 --> 00:35:53.800 Dana Carroll: And then the other group that we focused on was those who have been racialized as black in America, and that's really because, interestingly, though, despite having a either similar or lower smoking prevalence, persons who identify as black were more likely to die due to smoking. And so we thought these would be 3 key groups to really 184 00:35:53.910 --> 00:35:57.420 Dana Carroll: focus on. As part of these moderator analyses. 185 00:35:58.390 --> 00:36:00.799 Dana Carroll: I just wanted to mention that 186 00:36:00.940 --> 00:36:15.400 Dana Carroll: the methods that were conducted in the parent study that I just covered, pertaining to statistical analyses were maintained for these moderator analyses. 187 00:36:15.530 --> 00:36:17.230 Dana Carroll: I will say, too. 188 00:36:17.430 --> 00:36:23.169 Dana Carroll: and this comes up in review a lot, you know. When do you know there is moderation? And so we 189 00:36:23.310 --> 00:36:26.050 Dana Carroll: take the approach. Looking at both 190 00:36:26.450 --> 00:36:37.130 Dana Carroll: point estimates between 2 groups. So, for example, older and younger adults looking at their outcomes as well as doing the test for interaction. 191 00:36:37.450 --> 00:36:42.180 Dana Carroll: knowing that if it's not point O 5 or less, that kind of 192 00:36:42.290 --> 00:36:53.439 Dana Carroll: arbitrary cut point that we like to call significant. But it's maybe around less than 0 point 1 that's a signal for us. So we're really just looking and exploring for moderation. 193 00:36:55.090 --> 00:37:03.459 Dana Carroll: So here's the results. And they're displayed just a little differently, just to try and make it easier to see across the moderators. 194 00:37:03.670 --> 00:37:12.169 Dana Carroll: So this is looking at the average difference in cigarettes per day between the low nicotine group versus the normal nicotine group 195 00:37:12.370 --> 00:37:14.989 Dana Carroll: at the end of the study, the end of the 12 weeks 196 00:37:15.090 --> 00:37:20.830 Dana Carroll: across the different moderator groups that we were interested in, and essentially what you see is a 197 00:37:21.100 --> 00:37:42.450 Dana Carroll: negative axis vertical axis, which means that the low nicotine group resulted in significant reductions in cigarettes per day compared to the normal nicotine group for all the groups that we were interested in, and there was no evidence that the magnitude of effect was meaningfully different. 198 00:37:45.440 --> 00:37:58.839 Dana Carroll: We also looked at incident rate, ratios of smoke, free days during the intervention period, and so the higher the rate, the better for the low nicotine versus the normal nicotine group 199 00:37:59.000 --> 00:38:17.589 Dana Carroll: and for racial identity and educational attainment. There was no evidence to us based on really looking at these point estimates and the interaction test that there was moderation. But age did surface as a significant moderator. So 200 00:38:17.740 --> 00:38:24.429 Dana Carroll: the number of smoke, free day, smoke-free days, with the very low versus normal nicotine. 201 00:38:24.660 --> 00:38:41.649 Dana Carroll: while, was in the right direction. So 2.2 7 in the low nicotine group compared to normal, it just wasn't as high as that in the Younger age group. So it's the older age group are benefiting just less. So 202 00:38:43.670 --> 00:38:58.369 Dana Carroll: this is that biomarker again, Sema. And we did look at other biomarkers that. And so there is more that will come with this publication. But with Sema we also saw a similar result 203 00:38:58.390 --> 00:39:14.610 Dana Carroll: with the age group. So this is a geometric mean ratio. So basically, if we're going to say the low nicotine group is better, we want a lower ratio. And so, as you see, those 55 and plus had a ratio 204 00:39:14.820 --> 00:39:35.499 Dana Carroll: that was actually no significantly different than one meaning. There was no difference between the 2 groups, whereas those that were younger had a significant reduction in Sema at the end of the study, and that to us was just not these point estimates, but actually the interaction test was 205 00:39:35.670 --> 00:39:41.550 Dana Carroll: significant. And then lower education also 206 00:39:41.660 --> 00:39:49.719 Dana Carroll: rises to a concern with potentially having a signal for for moderation, and so that 207 00:39:50.240 --> 00:40:13.189 Dana Carroll: the interaction test was not significant. But we looked at the point estimates here, and I think that the p-value was around 0 point 1 to 0 point 2. So again for us, it really raised a potential concern that the Lower Education group, while in the right direction they weren't achieving significant reductions in Sema. 208 00:40:14.650 --> 00:40:19.199 Dana Carroll: So I think this slide here helps us understand why that is. 209 00:40:19.500 --> 00:40:36.859 Dana Carroll: and I actually included sex on this slide, too, just in case folks are interested that was not found to moderate any of the outcomes. So, as you see in the gold brackets. Those who are 55 plus age and lower education 210 00:40:36.970 --> 00:40:47.869 Dana Carroll: had about either 7 or 8% of those in the low nicotine group that had completely switched to non combustive products or were not using 211 00:40:48.020 --> 00:41:02.179 Dana Carroll: any products at all. So that is actually quite lower than all of the other groups that you see here. And so the question is, you know, what could be going on in these groups 212 00:41:02.300 --> 00:41:10.310 Dana Carroll: that has resulted in them being less likely to be nudged off low nicotine cigarettes. 213 00:41:11.740 --> 00:41:28.540 Dana Carroll: And so this is really a slide of kind of post hoc analyses and trying to think about some of the implications of those findings. So again, age and potentially educate lower education are 2 groups that could be mindful of for moderation. 214 00:41:29.350 --> 00:41:43.310 Dana Carroll: The background of this is that the majority who quit low nicotine cigarettes did switch to actually an e-cigarette. And we see that saw that this occurred less so in those of older age and lower education. 215 00:41:43.926 --> 00:41:59.119 Dana Carroll: Actually, there's been some analyses that have shown that there's a stagnation in the older age, smoking prevalence, and one contributor to that is being less likely to switch to non combusted tobacco products. 216 00:41:59.400 --> 00:42:01.890 Dana Carroll: So we looked in post hoc analyses. 217 00:42:02.070 --> 00:42:16.919 Dana Carroll: And I tried to illustrate this with my clip art here, but essentially on your left. What it shows is that the older age has more social influences, close friends who smoke cigarettes 218 00:42:17.586 --> 00:42:23.780 Dana Carroll: relative to e-cigarettes than the Younger Age and Higher Education group has. 219 00:42:24.110 --> 00:42:51.969 Dana Carroll: So, in other words, perhaps social norms may impact low nicotine cigarette use in our study one of the things that we cannot mimic in these studies is that all smokers would be subject to a low nicotine standard. So, in other words, folks in our low nicotine group are taking home their products. They're around their peers who are smoking or using other tobacco products. 220 00:42:52.030 --> 00:43:01.869 Dana Carroll: And so that is the reality of some of the limitations of these studies, so shall this standard be implemented for all smokers. 221 00:43:02.070 --> 00:43:05.121 Dana Carroll: Perhaps the social norms would play 222 00:43:05.750 --> 00:43:18.519 Dana Carroll: less of a role. But I think the take home is for us that those of older age and lower educational attainment might need more support to quit low nicotine cigarettes. 223 00:43:18.650 --> 00:43:33.410 Dana Carroll: They are still benefiting compared to the normal nicotine cigarettes. Just less so. And so, maybe that is more tailored, direct education. On quitting and referral to smoking cessation resources. 224 00:43:33.990 --> 00:43:36.370 Dana Carroll: we'll come back to this in a minute. 225 00:43:37.670 --> 00:43:55.260 Dana Carroll: I also want to mention a study that I have been involved with with David Mendez and Tui Lee and Joe Mcclearnan. And so this is a modeling study that we are hoping to get published shortly and essentially 226 00:43:55.570 --> 00:44:08.469 Dana Carroll: what this slide shows, which I'll tell you why. That is in a moment that this policy will actually likely serve as a pro health equity policy. When we look at race groups and rural residing persons. 227 00:44:08.630 --> 00:44:14.310 Dana Carroll: So what we did is we modeled the impact by 228 00:44:14.510 --> 00:44:23.129 Dana Carroll: 24 different scenarios, some really conservative of the impact of the standard, some more in alignment with what we actually are seeing in the clinical trials. 229 00:44:23.460 --> 00:44:29.070 Dana Carroll: and looked at the deaths averted by 2,100. 230 00:44:29.680 --> 00:44:38.459 Dana Carroll: What we found for American, Indian, black, and rural people is that the proportion of deaths averted 231 00:44:38.840 --> 00:44:45.859 Dana Carroll: of the total deaths averted was larger than the proportion these folks represent in the population. 232 00:44:46.260 --> 00:45:02.850 Dana Carroll: It's kind of a lot of words, but essentially it's an outsized impact than what would be expected. And that's because for American Indian, black and rural people, they either have such low cessation rates or high initiation rates. 233 00:45:02.960 --> 00:45:21.939 Dana Carroll: and the standard would really help these folks potentially catch up with their counterparts. Certainly we see deaths averted in the other groups, but it just stood out to us that the deaths averted in these 3 groups would be outsized for what you would expect. 234 00:45:23.730 --> 00:45:24.760 Dana Carroll: so 235 00:45:25.620 --> 00:45:43.579 Dana Carroll: that finding actually really corresponds with the most recent surgeon. General report released, I think, just in November of 2024, and that report concluded that reducing nicotine and cigarettes and other combusted tobacco products to minimally addictive or non-addictive levels 236 00:45:43.800 --> 00:45:47.220 Dana Carroll: should reduce tobacco use among population groups. 237 00:45:47.570 --> 00:45:55.989 Dana Carroll: Certainly we believe that. And actually, because of the initiation and cessation rates in certain populations it could have an outsized benefit. 238 00:45:58.590 --> 00:46:00.580 Dana Carroll: So to wrap this up 239 00:46:00.890 --> 00:46:11.019 Dana Carroll: with some conclusions and implications. If you haven't been listening tune in now. So we showed through this study that a nicotine 240 00:46:11.130 --> 00:46:20.000 Dana Carroll: in an effort to mimic a nicotine reduction standard, if implemented in a diverse marketplace, it's likely to reduce smoking and harmful exposures 241 00:46:20.270 --> 00:46:23.289 Dana Carroll: over the status quo diverse marketplace. 242 00:46:23.770 --> 00:46:35.680 Dana Carroll: There's some reason to believe that the older age group and the lower education groups may benefit less so, and so providing them with some extra attention during implementation of the standard, is warranted. 243 00:46:36.360 --> 00:46:47.920 Dana Carroll: This is not a silver bullet. Unfortunately, I don't think that will ever exist for tobacco control, dual use, and exclusive smoking, even with the low nicotine cigarettes, was still common. 244 00:46:48.190 --> 00:46:50.190 Dana Carroll: And so this really reflects that 245 00:46:50.560 --> 00:47:05.899 Dana Carroll: this standard. If, when implemented, should be implemented as part of a comprehensive plan that includes education on smoking, cessation, access to medication and surveillance. After the implementation. 246 00:47:06.730 --> 00:47:27.300 Dana Carroll: again, I will say that the other promising avenue aligns with the FDA strategic plan which is to educate consumers about the relative risk of tobacco products and complete switching that was not done in this study we only provided packaging to participants based on 247 00:47:27.540 --> 00:47:40.009 Dana Carroll: what they look like in the real world, and so providing health communications in a more formal way would certainly be warranted. And this is just one idea that aligns with the FDA. 248 00:47:41.530 --> 00:47:56.619 Dana Carroll: So I want to make several acknowledgments. I am presenting here. But this was a well-oiled machine. This particular study was led by Dorothy Hatsukami and Dorothy and Eric Donnie were the pis of scenic. 249 00:47:57.190 --> 00:48:04.359 Dana Carroll: and certainly, as you see here, there were a lot of other folks and sites that contributed to this project. 250 00:48:04.530 --> 00:48:08.329 Dana Carroll: So I'm just thankful for the experience, and being part of the team. 251 00:48:08.540 --> 00:48:14.470 Dana Carroll: and with that we have time for all the additional questions that folks have. 252 00:48:14.870 --> 00:48:22.439 Jamie Hartmann-Boyce: Thank you so much, Dana. That was a fantastic presentation. It was great to hear about those results. I'll turn over to our discussant for a final time. 253 00:48:23.730 --> 00:48:30.419 Justin Byron: Hi, Dana! Again. Excellent presentation! A lot of thought went into the study. One of the things 254 00:48:30.840 --> 00:48:39.399 Justin Byron: I haven't noticed when I saw your slides in advance, and this, I think, would be worth mentioning. Right is, what are the potential implications for cannabis or alcohol use. 255 00:48:40.870 --> 00:48:51.519 Dana Carroll: Yes, thanks, Justin. We actually have a postdoc. Emily, Dr. Emily Hackworth, who's working with Dorothy and I, who is looking at this very specific question. 256 00:48:51.640 --> 00:48:54.210 Dana Carroll: and I think it stems from a concern, that 257 00:48:54.820 --> 00:49:03.620 Dana Carroll: of substitution. So when we reduce nicotine and cigarettes, this is just going to give rise to unintended consequences in cannabis and alcohol use. 258 00:49:03.760 --> 00:49:06.749 Dana Carroll: and her findings 259 00:49:06.890 --> 00:49:19.999 Dana Carroll: of this most recent marketplace study show no concerning increases or no actually, differences in cannabis and alcohol use in the low nicotine condition compared to the normal. 260 00:49:20.250 --> 00:49:28.589 Dana Carroll: this tracks with other studies. There was a study out of Vermont, the Vermont group that looked at 261 00:49:29.040 --> 00:49:41.219 Dana Carroll: Thc. So they looked at cannabis and alcohol, and they also found no concerning increases, and I believe actually it was no increases. But I'd have to look back at that paper. 262 00:49:41.370 --> 00:49:50.720 Dana Carroll: and we also found in some prior studies that without a marketplace, that 263 00:49:50.910 --> 00:49:56.789 Dana Carroll: this is a 20 week study that Dorothy had done, that the low nicotine group 264 00:49:57.020 --> 00:50:00.330 Dana Carroll: might give rise to 2 more days a year 265 00:50:00.630 --> 00:50:12.039 Dana Carroll: of cannabis use compared to the normal nicotine. So it's quite small, and I would say not concerning, but that doesn't mean we don't want to do surveillance. 266 00:50:12.440 --> 00:50:27.509 Dana Carroll: I will say also a prior study on alcohol, which we're looking into with the most recent marketplace found that right after folks in the low nicotine group got their low nicotine cigarettes. 267 00:50:27.740 --> 00:50:41.540 Dana Carroll: there was a potential signal for increase in binge drinking that correspond with like nicotine withdrawal period. But then, at the end of the study, there was no difference in alcohol over time. 268 00:50:41.680 --> 00:51:08.800 Dana Carroll: And so I think these are really important questions and important to monitor with cannabis. We've certainly had a change in the legalization. And so, you know, I think, if further studies are conducted during this interim. Where the rulemaking is continuing, it will be important to continue to monitor cannabis as a unintended consequence. But 269 00:51:09.000 --> 00:51:11.680 Dana Carroll: the nutshell is we've looked at it? 270 00:51:11.970 --> 00:51:14.550 Dana Carroll: No, concerning increases. 271 00:51:16.200 --> 00:51:16.950 Justin Byron: Thank you. 272 00:51:19.200 --> 00:51:31.659 Justin Byron: I guess one other question. It's more of a hypothetical. All of this, as good science is rooted in the idea of you kind of only address, you only change one variable at a time. Right? You give people low nicotine cigarettes or not. 273 00:51:31.900 --> 00:51:40.960 Justin Byron: In reality, the tobacco industry is likely to change what they do in response to a new policy. Right? They could easily change their prices. It's a very profitable product. 274 00:51:41.560 --> 00:51:43.080 Justin Byron: Have you thought about 275 00:51:43.690 --> 00:51:49.469 Justin Byron: what the tobacco industry is likely to do in the event of a Vlmc. Policy, and how that would affect 276 00:51:49.600 --> 00:51:51.449 Justin Byron: the actual rates of smoking. 277 00:51:52.030 --> 00:51:52.690 Dana Carroll: Hmm. 278 00:51:53.600 --> 00:51:55.890 Dana Carroll: I would fathom that they would 279 00:51:56.580 --> 00:52:00.419 Dana Carroll: push non-combusted tobacco products even more. 280 00:52:00.800 --> 00:52:08.560 Dana Carroll: And so maybe that would actually further encourage smoking cessation 281 00:52:08.810 --> 00:52:11.829 Dana Carroll: and ultimate harm reduction, knowing that 282 00:52:12.780 --> 00:52:20.459 Dana Carroll: complete quitting of all tobacco products is ideal. But not all smokers have that goal or interested in that goal. So 283 00:52:20.820 --> 00:52:24.540 Dana Carroll: you know, I would not be surprised that the industry just ramps up 284 00:52:24.960 --> 00:52:29.859 Dana Carroll: their efforts that they have been doing already to promote noncombusted tobacco products. 285 00:52:30.600 --> 00:52:35.800 Dana Carroll: You know, I think the price question is interesting. The coupons, I mean. 286 00:52:36.080 --> 00:52:41.970 Dana Carroll: Certainly they could discount non-combusted tobacco products even more with coupons. 287 00:52:42.170 --> 00:52:49.960 Dana Carroll: Definitely an interesting question to know what the industry will do. Shall the standard go forward. 288 00:52:51.390 --> 00:52:55.449 Justin Byron: And that's true, too. Right? They could make moves that would benefit public health. Right? It's 289 00:52:55.580 --> 00:53:03.430 Justin Byron: potentially possible. Some company kind of like the electric car companies have gone with electric cars, and they said, We're only going to make electric cars starting in 10 years. Tobacco. 290 00:53:03.430 --> 00:53:03.860 Dana Carroll: Yes. 291 00:53:03.860 --> 00:53:07.510 Justin Byron: Decide to stop making the harmful cigarettes that are not selling. Well. 292 00:53:08.180 --> 00:53:09.080 Justin Byron: So thank you. 293 00:53:09.530 --> 00:53:13.010 Justin Byron: Presentation. And I'd love to leave time for other people's questions. 294 00:53:13.610 --> 00:53:30.041 Dana Carroll: Sure. Yeah. And to me, you know, I don't know if they the industry, was really interested in public health, they would just get rid of cigarettes, so I don't. So while they might do things that do benefit public health, you know, the bottom line is the dollar. So 295 00:53:30.820 --> 00:53:32.950 Dana Carroll: I think, sometimes both are achieved. 296 00:53:35.150 --> 00:53:58.530 Jamie Hartmann-Boyce: Thanks so much, Justin. So we have time for maybe one or 2 more Q. And A's. Please keep them coming through the Q&A panel. But if we don't have a chance to get to all questions, or if you'd like to discuss with the speaker directly with mics enabled, you're very welcome to attend top of the tops immediately following this webinar. If interested, please copy the meeting. URL posted in the chat now, so that you'll be ready to join the live discussion once this webinar concludes. 297 00:53:59.020 --> 00:54:21.850 Jamie Hartmann-Boyce: So, Dana, another kind of speculative question right now. We wish you had a crystal ball. We know you don't. Do you believe that the Us. Government has the ability to prevent the market from being flooded with illegal high nicotine cigarettes when they implement the low nicotine standard for cigarettes, thinking about their inability to prevent the E-cig market being dominated by unauthorized products currently. 298 00:54:23.740 --> 00:54:47.089 Dana Carroll: Yeah, that is a very good question. I know it comes up a lot. And I think this is what we're hearing a lot in the news about this like explosion of illicit marketplace. I'd be happy to to talk with folks after this and hear their thoughts. There's definitely some really helpful papers out there that have been written by Kurt Rebsol and others, and Dorothy is on that paper as well about what we can actually anticipate 299 00:54:47.250 --> 00:54:50.169 Dana Carroll: when it comes to the illicit, to the illicit marketplace. 300 00:54:50.410 --> 00:54:54.920 Dana Carroll: I think to me, you know, this is not like prohibition. 301 00:54:55.250 --> 00:54:59.219 Dana Carroll: low nicotine cigarettes will still be available, although less appealing. 302 00:54:59.430 --> 00:55:05.910 Dana Carroll: but a variety of noncombusted tobacco products will. And if smokers want to shift over to that. 303 00:55:06.260 --> 00:55:10.119 Dana Carroll: and they're available legally, that to me, seems like 304 00:55:10.230 --> 00:55:26.570 Dana Carroll: a way to really kind of reduce our concern with the illicit market. But it is definitely, you know, a concern. I think surveillance is important. The paper I mentioned talks about a track and trace system 305 00:55:26.850 --> 00:55:35.709 Dana Carroll: that could be implemented kind of like, how cannabis, from like seed to sale, to ensure monitoring in the of the illicit marketplace. 306 00:55:36.279 --> 00:55:42.780 Dana Carroll: But you know most smokers do want to quit. I think that's also important. It's just hard to do it with 307 00:55:43.660 --> 00:55:46.340 Dana Carroll: legal products that are so addictive. 308 00:55:46.450 --> 00:55:50.239 Dana Carroll: And so I think that's also important to keep in mind, but 309 00:55:50.820 --> 00:55:57.629 Dana Carroll: would happy to share some some papers, because this is definitely an important concept to to be concerned about. 310 00:55:58.560 --> 00:56:13.889 Jamie Hartmann-Boyce: Thank you, and probably our last question for today, given the time. But do keep them coming in the Q. And a. And we'll send them through afterwards. Do you have any thoughts on how brand identification might affect Vlmc uptake, especially with older longtime smokers. 311 00:56:17.220 --> 00:56:19.010 Dana Carroll: If I'm following it. 312 00:56:19.300 --> 00:56:21.150 Dana Carroll: Brand identity. So 313 00:56:22.466 --> 00:56:29.289 Dana Carroll: it would be helpful to know a little more context. But just to kind of talk out loud, you know, all cigarette brands 314 00:56:29.660 --> 00:56:35.230 Dana Carroll: sold in the United States would be impacted. And so all of them would have now low nicotine cigarettes. 315 00:56:37.650 --> 00:56:44.700 Dana Carroll: is, you know I would. I would be happy to hear more. What the, what, what the question is really getting at, and not following completely. 316 00:56:44.700 --> 00:56:47.360 Jamie Hartmann-Boyce: I. So I'm maybe making a guess here, and I apologize. 317 00:56:47.360 --> 00:56:47.920 Dana Carroll: Okay. 318 00:56:47.920 --> 00:57:01.459 Jamie Hartmann-Boyce: Wrong. But the way that I interpret this is, let's say you're a bullet smoker, and that's what you identify as do we think that people would continue using that same brand in Vl and C form. 319 00:57:02.460 --> 00:57:04.800 Dana Carroll: Yeah, that's a good question. I would. 320 00:57:05.130 --> 00:57:23.919 Dana Carroll: I don't know if we have any empirical way to look at that. But yes, you know, I think just in general, smokers will find that their cigarettes are unappealing and not fulfilling their their helping with their nicotine withdrawal. So 321 00:57:24.070 --> 00:57:32.909 Dana Carroll: those that do continue low nicotine cigarettes, they would jump around to different brands. I'm not sure but I would would assume that, you know 322 00:57:33.580 --> 00:57:38.929 Dana Carroll: Brand is not just due to nicotine. Right? Brand is nicotine's 323 00:57:39.210 --> 00:57:53.680 Dana Carroll: pretty similar among commercially available cigarettes. Except for the low nicotine cigarettes that are available in the marketplace. And so there's a lot that goes into the blend of the tobacco and the marketing of the tobacco packs. And so 324 00:57:55.530 --> 00:57:56.940 Dana Carroll: We can only speculate. 325 00:57:57.250 --> 00:58:03.289 Jamie Hartmann-Boyce: Great. Thank you so much, Dana. I'm going to turn over to today's Mc. To lead us out. 326 00:58:05.870 --> 00:58:33.280 Monserrat Conde: We are out of time. However, if you still have burning questions or thoughts for Dr. Carol, you can join us for top of the tops an interactive group discussion to join. Please copy the Zoom Meeting room. URL posted in the chat and switch rooms with us. Once this event concludes, we'll leave the Webinar room open for an extra minute after the end to give everyone a chance to copy the URL, which is 327 00:58:33.530 --> 00:58:38.910 Monserrat Conde: bit.ly. Slash topsmeeting all lowercase. 328 00:58:39.030 --> 00:58:50.439 Monserrat Conde: Thank you to our presenter moderator and discussant. Finally, thank you to the audience of 230 people for your participation. Have a top-snotch weekend.