A Phase 4 interventional study of Varenicline Pill and Contingency management in Nicotine Dependence and Tobacco Use Disorder, sponsored by Medical University of South Carolina. Recruiting at 3 sites in United States. Open to participants aged 18 Years to 40 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-06-12.
Sponsored by Medical University of South Carolina · Phase 4, Interventional, and Treatment
The purpose of this study is to better understand tobacco outcomes using a commonly prescribed stop smoking medication (varenicline) and financial incentives for adults who also use cannabis. Varenicline is not FDA approved for e-cigarette cessation, but is FDA approved for cigarette cessation. Investigators are also interested in how cannabis/marijuana and tobacco interact during a tobacco quit attempt. All participants will receive e-cigarette cessation treatment for 12 weeks. To qualify, participants must be between the ages of 18-40 and use both e-cigarettes and cannabis. Participants do not need to be interested in quitting cannabis to qualify. This study is being conducted at three sites: the Medical University of South Carolina in Charleston, SC, Behavioral Health Services in Pickens, SC, and MUSC Lancaster in Lancaster, SC.
Cannabis co-use among tobacco users is exceedingly common and rates of co-use appear to be increasing among adults in the US, which is consistent with overall increases in cannabis use rates among US adults. Given the current cannabis landscape, further increases in cannabis use are likely and may result in continued increases in the co-use of cannabis and tobacco.
Despite high rates of co-use, there is little consensus regarding treatment recommendations for this population and an understanding of the impact of co-use on successful cessation. The literature on the impact of co-use on tobacco cessation outcomes specifically has been mixed and fraught with limitations, including methodological variation, lack of biochemical verification to confirm cannabis use status and severity, and variations in study samples. Currently, no prospective studies have been conducted to evaluate the impact of cannabis use on tobacco cessation outcomes. Further, no studies have collected cannabis use changes during tobacco cessation treatment to assess for concurrent reductions, abstinence, or of greater concern, compensatory (i.e., increased) use as a result of tobacco reduction/abstinence.
This study is a prospective 12-week tobacco cessation trial using established methods and outcomes typical of tobacco cessation trials, but specifically recruiting co-users of cannabis. The aims of this proposed study are to; Specific Aim 1. Compare rates of 7-day biochemically-confirmed e-cigarette abstinence with cigarette abstinence rates from the parent R37 co-use sample (as a historical controls). Specific Aim 2. Assess changes in cannabis use during e-cigarette cessation treatment among the new sample of participants enrolled in this extension.
Specific Aim 3. Assess for a dose-dependent impact of cannabis co-use severity on e-cigarette cessation. Specific Aim 4. Characterize and compare patterns of co-use among the e-cigarette sample to those using cigarettes (parent R37).
1,027 studies on the registry are indexed under Tobacco Use Disorder; 128 are open to participants now.
This study's planned enrollment of 105 is above the median of 90 across 892 interventional studies indexed under Tobacco Use Disorder.
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Of its 131 completed or terminated interventional studies of FDA-regulated products, 104 (79%) have results posted.
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Exclusion Criteria:
E-cigarette and cannabis co-use group
Drug: Varenicline Pill · Behavioral: Contingency management · Behavioral: Counseling
In this study, all participants will be administered active medication for a 12 week treatment period. The standard dose titration schedule will be used, which includes 0.5 mg once per day (q.d.) on Days 1-3, 0.5 mg twice per day (b.i.d.) on Days 4-7, and 1.0 mg b.i.d. starting on Day 8. Dosing of 2.0 mg per day will be maintained for the next 11 weeks, for a total of 12 weeks of active treatment for all study participants.
Contingency management procedures will be implemented and financial incentives will be provided at weekly visits contingent on e-cigarette abstinence verified through urinary qualitative cotinine (starting at Week 2). A set amount of $20 per study visit will be delivered based on a negative qualitative urinary cotinine result.
Psychosocial counseling will be administered by trained research staff leading up to the target quit date and throughout the study.
7-day point prevalence tobacco abstinence at the end of treatment (Week 12)
7-day point prevalence abstinence from e-cigarettes at the end of treatment (Week 12) will be assessed via biochemical verification (urinary cotinine; ng/ml) and will be compared to cigarette abstinence rates from the parent study (as historical controls)
Time frame: Final 7 days of treatment (Week 12)
Changes in cannabis use during e-cigarette cessation treatment
Cannabis use rates (based on urinary cannabinoids \[ng/ml\]) during the final 4 weeks of tobacco treatment (Weeks 8-12) will be assessed.
Time frame: Final 4 weeks of study treatment (Weeks 8-12)
Cannabis co-use severity on e-cigarette abstinence rates
Assess for a dose-dependent impact of cannabis co-use severity on e-cigarette cessation.
Time frame: Final 7 days of treatment (Week 12)
Plan to share: Yes — De-identified data will be made available for retrieval and analysis of secondary outcomes, upon request to the Principal Investigator. Study datasets (de-i
Supporting information: Study protocol, Informed consent form
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Studies of the drug tested here: Varenicline
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