Education and Safety for Children with Autism to Prevent Elopement (ESCAPE) Kits Pilot Study

Date Added
April 13th, 2021
PRO Number
Pro00108386
Researcher
Silvia Pereira-Smith

List of Studies


Keywords
Autism
Summary

This study will evaluate elopement prevention kits for children with autism spectrum disorder who exhibit elopement behavior such as dashing or wandering away from safe settings. Caregivers will be asked to rate how useful individual kit items are at reducing elopement, and to provide feedback about how ESCAPE kits affect their stress levels and ability to engage meaningfully in community settings. This study will also investigate how useful kit items are for various age groups in childhood and adolescence. Information will be used to guide development of a larger elopement prevention program.

Institution
MUSC
Recruitment Contact
Jessie Montezuma
843-714-1352
montezum@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
Yunuen Lupian
843-876-2441
lupian@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
Yunuen Lupian
843-876-2441
lupian@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
Yunuen Lupian
843-876-2441
lupian@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
J'Neice Hunter
843-876-2291
paynejne@musc.edu



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