Cigarette Smoking Clinical Trial
Official title:
Non-cigarette Tobacco Products as Harm Reduction Tools in Smokers Who Failed to Quit With Traditional Methods
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.
Status | Not yet recruiting |
Enrollment | 225 |
Est. completion date | August 2027 |
Est. primary completion date | May 2027 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | All |
Age group | 21 Years and older |
Eligibility | Inclusion Criteria - Adults 21+ who previously had a quit attempt using FDA-approved pharmacotherapy. - Interest in reducing harms from tobacco use or quitting smoking Exclusion Criteria - Pregnant, breastfeeding, or trying to become pregnant. - Household member currently enrolled in the study - Planning to move out of the area within the next 7 months |
Country | Name | City | State |
---|---|---|---|
United States | Medical Univeristy of South Carolina | Charleston | South Carolina |
Lead Sponsor | Collaborator |
---|---|
Medical University of South Carolina | National Institute on Drug Abuse (NIDA) |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Biochemically-confirmed 7-day point prevalence abstinence from cigarettes on timeline followback | Self-reported zero cigarettes in the past 7 days on timeline followback at Week 11 + expired carbon monoxide < 6 ppm | 11 Weeks | |
Secondary | Greater than 50% reduction in cigarette smoking | Average reduction in the number of cigarettes smoked per day on 7-day timeline followback at Week 11 of at least 50% or greater compared to average baseline number of cigarettes smoked per day on 7 day timeline followback | 11 Weeks |
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