Dual use of combustible and electronic cigarettes: A fine-grained naturalistic cohort study to investigate dynamic use patterns and trajectories that lead to smoking cessation

Date Added
April 12th, 2024
PRO Number
Pro00135997
Researcher
Matthew Carpenter

List of Studies


Keywords
Smoking
Summary

This is a research study to examine if and how patterns of use change over time among three different groups of tobacco users: 1) adults who exclusively smoke combustible cigarettes, 2) adults who exclusive use e-cigarettes, and 3) adults who use both. This is a naturalistic survey study, there is nothing required or requested of participants, other than to complete our surveys. Participants do not need to quit or reduce their smoking/e-cigarette use if they do not want to. They do not need to travel for this study; it is completely remote and they can participate from your home.
Participation in the study will take place over a period of 12 months in the form of: 1) Monthly Surveys (13 total), 2) Daily Diaries for the first 90 days, 3) Follow-Up Diaries in each of the 7 days leading up to each monthly follow-up survey, and 4) Submission of Breath Samples (13 total).

Institution
MUSC
Recruitment Contact
Avery Roberson
843-876-2441
robersav@musc.edu

Comparison of Theta Burst versus 10 Hz Repetitive Transcranial Magnetic Stimulation for Craving in Smokers

Date Added
February 6th, 2024
PRO Number
Pro00121128
Researcher
Xingbao Li

List of Studies


Keywords
Brain, Healthy Volunteer Studies, Smoking
Summary

Smoking is one of the main public health problems. Smoking cessation is difficult because of nicotine dependence. Repetitive transcranial magnetic stimulation (rTMS) over the frontal head has shown to be effective in the reduction of cigarette consumption and craving. In this study, we will evaluate the efficiency of a new form of rTMS called intermittent theta-burst stimulation (iTBS) for smoking cessation.

Institution
MUSC
Recruitment Contact
Morgan Dancy
843 8765-141
maddoxm@musc.edu

The impact of cannabis and tobacco/nicotine product co-use in young adults: Prospective cessation evaluation and substitution

Date Added
September 15th, 2023
PRO Number
Pro00131124
Researcher
Erin McClure

List of Studies


Keywords
Smoking, Substance Use
Summary

The goal of this project is to better understand the relationship between tobacco/nicotine and cannabis using behavioral economics during a tobacco/nicotine quit attempt. All participants will receive tobacco/nicotine cessation treatment (smoking and/or vaping treatment) for 12 weeks. To qualify, participants must be between the ages of 18-25 and use tobacco products (smoke cigarettes and/or vape nicotine) and use cannabis (in any form). Participants do not need to be interested in quitting cannabis/marijuana to qualify. This study is being conducted by the Medical University of South Carolina. All procedures are conducted remotely and there is no in-person visits are needed.

Institution
MUSC
Recruitment Contact
Elizabeth Chapman
843-792-4097 or 843-284-9933
smokingstudy@musc.edu

A clinical trial of adaptive treatment for early smoking cessation relapse

Date Added
May 2nd, 2023
PRO Number
Pro00128175
Researcher
Tracy Smith

List of Studies


Keywords
Smoking
Summary

This is a research study to find out if treatment decision making can be improved for smokers who find it difficult to quit with medications. Everyone who participates in this study will receive free product, either nicotine replacement therapies (patches and lozenges), varenicline, or a harm reduction product (e-cigarette) for a full 12 weeks. Most participants will receive some combination of these treatments, depending on individual response to each.

All visits and study assessments will be entirely remote. All treatments will be provided free of charge for the first 12 weeks. After that, the study team will contact the participants 6 months after the first study phone call to complete another survey. The study lasts six months and will involve 8 surveys.

Institution
MUSC
Recruitment Contact
Avery Roberson
8438762441
robersav@musc.edu

Non-cigarette tobacco products as harm reduction tools in smokers who failed to quit with traditional methods

Date Added
January 3rd, 2023
PRO Number
Pro00125514
Researcher
Tracy Smith

List of Studies


Keywords
Smoking
Summary

This study evaluates whether non-cigarette tobacco products (e-cigarettes) can help smokers quit smoking as compared to traditional quit methods (nicotine replacement therapy or varenicline/Chantix). Participants in this study will be randomly assigned to one of two groups, then will have a choice between the offered products of that group. Participants in the e-cigarette group will have a choice of e-cigarette brand and flavor. Participants in the medication group will have choice between nicotine replacement therapy (patches and lozenges) or varenicline, also known as Chantix. Participation will last 6 months and will include weekly phone calls for the initial 7-weeks plus a 11-week phone call and a 6-month follow-up visit. Participants will also complete electronic daily diaries during the first 7-weeks.

Institution
MUSC
Recruitment Contact
Hana Thamer
843-876-1266
thamer@musc.edu

Impact of cigarette and e-cigarette menthol regulation on current smokers of menthol cigarettes.

Date Added
October 4th, 2022
PRO Number
Pro00122898
Researcher
Tracy Smith

List of Studies


Keywords
Smoking
Summary

In a 2x2 design, current menthol smokers (N=240) will complete a baseline period before being assigned to a cigarette (menthol or non-menthol) and e-cigarette condition (menthol or tobacco-flavored e-liquid) and receiving a 7-week supply of cigarettes and e-cigarettes. The study builds upon our well-established methodology for simulating tobacco regulatory policies. To model a ban, smokers will be instructed to only use their assigned products. Primary outcomes include cigarette smoking and e-cigarette use during Week 6. However, because a menthol ban may impact the ability to abstain from smoking, we will incentivize participants to abstain from smoking during Week 7 (continued e-cigarette use allowed) and assess the time to first lapse. Participants will complete daily electronic diaries assessing tobacco product use throughout, which will be corroborated by biomarkers for menthol, nicotine, and smoke. Finally, to maximize the utility of these data for FDA regulation, we will assess whether any demographic or baseline smoking characteristics moderate the observed treatment effects, calibrate the treatment effects to the US adult menthol smoking population, and model the effects of menthol regulation in cigarettes and e-cigarettes on smoking and vaping-attributable deaths and life-years lost.

Institution
MUSC
Recruitment Contact
Hana Thamer
843-876-1266
thamer@musc.edu

Impact of cigarette and e-cigarette menthol regulation on current smokers of menthol cigarettes.

Date Added
October 4th, 2022
PRO Number
Pro00122898
Researcher
Tracy Smith

List of Studies


Keywords
Smoking
Summary

In a 2x2 design, current menthol smokers (N=240) will complete a baseline period before being assigned to a cigarette (menthol or non-menthol) and e-cigarette condition (menthol or tobacco-flavored e-liquid) and receiving a 7-week supply of cigarettes and e-cigarettes. The study builds upon our well-established methodology for simulating tobacco regulatory policies. To model a ban, smokers will be instructed to only use their assigned products. Primary outcomes include cigarette smoking and e-cigarette use during Week 6. However, because a menthol ban may impact the ability to abstain from smoking, we will incentivize participants to abstain from smoking during Week 7 (continued e-cigarette use allowed) and assess the time to first lapse. Participants will complete daily electronic diaries assessing tobacco product use throughout, which will be corroborated by biomarkers for menthol, nicotine, and smoke. Finally, to maximize the utility of these data for FDA regulation, we will assess whether any demographic or baseline smoking characteristics moderate the observed treatment effects, calibrate the treatment effects to the US adult menthol smoking population, and model the effects of menthol regulation in cigarettes and e-cigarettes on smoking and vaping-attributable deaths and life-years lost.

Institution
MUSC Health Florence Medical Center
Recruitment Contact
Hana Thamer
843-876-1266
thamer@musc.edu

Impact of cigarette and e-cigarette menthol regulation on current smokers of menthol cigarettes.

Date Added
October 4th, 2022
PRO Number
Pro00122898
Researcher
Tracy Smith

List of Studies


Keywords
Smoking
Summary

In a 2x2 design, current menthol smokers (N=240) will complete a baseline period before being assigned to a cigarette (menthol or non-menthol) and e-cigarette condition (menthol or tobacco-flavored e-liquid) and receiving a 7-week supply of cigarettes and e-cigarettes. The study builds upon our well-established methodology for simulating tobacco regulatory policies. To model a ban, smokers will be instructed to only use their assigned products. Primary outcomes include cigarette smoking and e-cigarette use during Week 6. However, because a menthol ban may impact the ability to abstain from smoking, we will incentivize participants to abstain from smoking during Week 7 (continued e-cigarette use allowed) and assess the time to first lapse. Participants will complete daily electronic diaries assessing tobacco product use throughout, which will be corroborated by biomarkers for menthol, nicotine, and smoke. Finally, to maximize the utility of these data for FDA regulation, we will assess whether any demographic or baseline smoking characteristics moderate the observed treatment effects, calibrate the treatment effects to the US adult menthol smoking population, and model the effects of menthol regulation in cigarettes and e-cigarettes on smoking and vaping-attributable deaths and life-years lost.

Institution
MUSC Health Lancaster Medical Center
Recruitment Contact
Hana Thamer
843-876-1266
thamer@musc.edu

Impact of cigarette and e-cigarette menthol regulation on current smokers of menthol cigarettes.

Date Added
October 4th, 2022
PRO Number
Pro00122898
Researcher
Tracy Smith

List of Studies


Keywords
Smoking
Summary

In a 2x2 design, current menthol smokers (N=240) will complete a baseline period before being assigned to a cigarette (menthol or non-menthol) and e-cigarette condition (menthol or tobacco-flavored e-liquid) and receiving a 7-week supply of cigarettes and e-cigarettes. The study builds upon our well-established methodology for simulating tobacco regulatory policies. To model a ban, smokers will be instructed to only use their assigned products. Primary outcomes include cigarette smoking and e-cigarette use during Week 6. However, because a menthol ban may impact the ability to abstain from smoking, we will incentivize participants to abstain from smoking during Week 7 (continued e-cigarette use allowed) and assess the time to first lapse. Participants will complete daily electronic diaries assessing tobacco product use throughout, which will be corroborated by biomarkers for menthol, nicotine, and smoke. Finally, to maximize the utility of these data for FDA regulation, we will assess whether any demographic or baseline smoking characteristics moderate the observed treatment effects, calibrate the treatment effects to the US adult menthol smoking population, and model the effects of menthol regulation in cigarettes and e-cigarettes on smoking and vaping-attributable deaths and life-years lost.

Institution
MUSC Heart and Vascular Institute
Recruitment Contact
Hana Thamer
843-876-1266
thamer@musc.edu

RTMS manipulates imbalanced drive-reward and executive control circuitry for smoking cessation

Date Added
March 2nd, 2021
PRO Number
Pro00105723
Researcher
Xingbao Li

List of Studies


Keywords
Brain, Healthy Volunteer Studies, Smoking
Summary

Cigarette smoking is a significant public health concern. Transcranial magnetic stimulation (TMS) is a non-invasive form of brain stimulation that has already displayed remarkable potential for producing novel, non-pharmacological interventions for depression and cigarette smokers. In this study, we will use brain MRI to guide TMS therapy for smoking cessation.

Institution
MUSC
Recruitment Contact
Xingbao Li
(843) 792-5729
lixi@musc.edu



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