An interventional study of Counseling and Contingency management in Tobacco Use Disorder and Nicotine Dependence, sponsored by Medical University of South Carolina. Recruiting at 1 site in United States. Open to participants aged 18 Years to 25 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-11-04.
Sponsored by Medical University of South Carolina · Not applicable, Interventional, and Treatment
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.
The co-use of nicotine/tobacco products and cannabis among young adults is prevalent and varies widely in terms of patterns and products of use. Nicotine-cannabis co-use among this age group may adversely affect treatment and other clinical outcomes, yet little is known regarding the underlying relationship between nicotine and cannabis and the resulting treatment implications, particularly during an attempt to quit or reduce use of one or both substances. Prior literature on the treatment implications of co-use, including results from our group, suggest that cannabis serves as an obstacle to nicotine cessation for a sub-set who use both products, though the literature is mixed. Past studies also suffer from important limitations, resulting in critical gaps in our understanding, with only 2 secondary analyses published from youth tobacco trials on the impact of co-use. To date, there are no prospective studies that have examined the treatment implications of nicotine-cannabis co-use or the underlying relationship between substances among young adults when engaged in a quit attempt.
Therefore, the overall goal of this project is to characterize and evaluate the underlying relationship between nicotine/tobacco and cannabis and its impact on nicotine cessation through a behavioral economics framework. This study will determine how impactful cannabis co-use may be on nicotine cessation and which individuals who co-use experience greater difficulty achieving cessation. To accomplish this goal, the investigators propose a completely remote, prospective, 12-week nicotine cessation trial among young adults (ages 18-25; N=350) from across the United States who use nicotine (vaping, cigarettes or both) and cannabis products regularly. Nicotine treatment includes remote contingency management (CM), text-based resources and counseling, while cannabis use will not be addressed. Biochemical verification (through oral fluid samples) and self-reports (mobile daily diaries) of substance use will be collected. The aims of this proposed study are to: 1) evaluate the impact of behavioral economically derived measures of substance substitutability on end of treatment nicotine abstinence (Aim 1); 2) determine if treatment-induced nicotine abstinence, reduction, and/or withdrawal (a) is associated with co-occurring changes in cannabis demand and use and (b) if substance substitutability modifies this relationship (Aim 2); and 3) assess the reciprocal prospective relationship between patterns of nicotine and cannabis use during nicotine treatment (Aim 3).
Evaluating nicotine-cannabis co-use as part of a prospective treatment study through a behavioral economics framework has never been conducted and will be important to informing the literature regarding individual co-use pattern differences, compensatory cannabis use, and treatment success. Nicotine cessation treatment in young adults is a growing body of work and the role of cannabis co-use, and results from the proposed study, will inform clinical care and guide tailored treatment recommendations to promote successful and sustained abstinence.
1,027 studies on the registry are indexed under Tobacco Use Disorder; 128 are open to participants now.
This study's planned enrollment of 350 is above the median of 90 across 892 interventional studies indexed under Tobacco Use Disorder.
Browse Tobacco Use Disorder studies →Medical University of South Carolina is the lead sponsor of 874 studies on the registry; 166 are open to participants now.
Of its 131 completed or terminated interventional studies of FDA-regulated products, 104 (79%) have results posted.
Counted across the registry records on this site, refreshed daily.
The criteria were revised on the registry on Nov 4, 2026. See what changed
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
All participants recieve active nicotine treatment for 12 weeks.
Behavioral: Counseling · Behavioral: Contingency management · Behavioral: Text-based support
Research staff will provide skills-based counseling at remote weekly visits, starting at Day 0. Counseling sessions will be brief (\~5-10 minutes) and will focus on strategies for preparing for the quit attempt, dealing with triggers, refusal skills, and enhancing motivation.
Contingency management (CM): CM will be provided to all study participants to promote abstinence from all nicotine products. Incentives for abstinence (based on submission of a negative cotinine sample) will be provided on an escalating schedule during treatment (Days 8-84).
All participants will be provided with evidence-based nicotine cessation resources. For those who are vaping nicotine, participants will be provided information for This is Quitting (SMS text-based program). For those who are primarily smoking cigarettes, NCI's QuitSTART (mobile app, web content), as well SmokefreeTXT (SMS-text based program), will be recommended, potentially in addition to This is Quitting for those using multiple products. These resources provide real time monitoring of nicotine use, mood, triggers and lapses.
7-day point prevalence nicotine abstinence at the end of treatment (Week 12)
7-day point prevalence abstinence from all nicotine/tobacco will be assessed at Week 12 through oral fluid cotinine biochemical verification and daily self-reported smoking or vaping.
Time frame: Final 7 days of treatment (Weeks 11-12 of tobacco treatment)
Changes in cannabis use during nicotine cessation treatment
Assess changes in co-occurring cannabis demand and use parameters (cannabis frequency and amount) and if the time varying effects of substance substitutability modify this relationship during tobacco treatment.
Time frame: Final 4 weeks of study treatment (Weeks 8-12)
Behavioral economic demand for cannabis during nicotine treatment
Investigate the reciprocal prospective relationship between patterns of nicotine and cannabis use during nicotine treatment.
Time frame: Throughout tobacco treatment (Weeks 1-12)
Plan to share: Yes — The final dataset for this study will ultimately be made available to qualified requestors following the publication of main study findings and removal of all human subject identifying information in accordance with NIH Data Sharing Policies. The PI and research team will work with MUSC's Office of Research and Sponsored Programs to properly abide by MUSC's and NIH's Data Sharing policy which is presented below. Distribution of data to specific requesting entities will be approved by the Institutional Review Board at MUSC in accordance with protection of human subjects and HIPAA guidelines. Data sharing will also require that written assurance is received by the PI to indicate by the institution that the data will be used only by the individual making the request and that no attempts will be made to deduce identification of study participants.
Supporting information: Study protocol, Informed consent form, Analytic code
Time frame: The final dataset for this study will ultimately be made available to qualified requestors following the publication of main study findings and removal of all human subject identifying information in accordance with NIH Data Sharing Policies.
Access criteria: Distribution of data to specific requesting entities will be approved by the Institutional Review Board at MUSC in accordance with protection of human subjects and HIPAA guidelines. Data sharing will also require that written assurance is received by the PI to indicate by the institution that the data will be used only by the individual making the request and that no attempts will be made to deduce identification of study participants.
Started May 2024 (actual). Primary completion is estimated for Oct 2027, 40 months after the start.
Of 255 non-industry interventional studies with no phase under Tobacco Use Disorder, half reached primary completion within 33 months of starting (the median), counting those still running; a quarter within 18 and three quarters within 51. This study's planned 40 months is above that.
Counting every sponsor, half of 265 studies reached it within 32 months; a quarter within 17 and three quarters within 50.
How these figures are worked out, and which studies are left out of them.
From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
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