Tobacco Use DisorderYouthCATNCT06239350
Young Adult Tobacco/Nicotine and Cannabis Co-use
A study testing Counseling, Contingency management and Text-based support in people with Tobacco Use Disorder and Nicotine Dependence, run by Medical University of South Carolina at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 25 yearsHealthy volunteers can take part
- Conditions the study is for
- Tobacco Use Disorder, Nicotine Dependence
- What is being tested?
- Counseling, Contingency management and Text-based support
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 350 participants
- Where
- 1 siteUnited States
- Study dates
- 13 May 2024to 3 Jan 2028
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 25 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Between the ages of 18 and 25 years old
- Must use at least one nicotine or tobacco product (nicotine vaping and/or cigarettes) on at least 20 out of the past 30 days for at least the past 3 months
- Must express interest in nicotine cessation (all products)
- Must submit a positive instant-read cotinine sample prior to enrollment
- Must report use of cannabis on at least 10 out of the past 30 days
- Must submit a positive instant-read cannabinoid test prior to enrollment
- Must be able to provide informed consent
Who cannot join
- Any significant or acutely unstable medical, psychiatric, or substance use problem that would contraindicate research, interfere with safety, compromise data integrity, or preclude consistent study participation
- Pregnant (self-report) or trying to become pregnant
- Self-reported use of medications with smoking cessation efficacy
- Immediate interest in cannabis cessation or treatment
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
Medical University of South Carolina - Charleston
Charleston, South Carolina, 29403
Ela Williams, 843-792-4097, williela@musc.edu
About this study
Official title: The Impact of Cannabis and Tobacco/Nicotine Product Co-use in Young Adults: Prospective Cessation Evaluation and Substitution
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.
Read the detailed description
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.
- Conditions
- Tobacco Use Disorder, Nicotine Dependence
- Being tested
- Counseling, Contingency management, Text-based support
- Keywords
- tobacco, vaping, cessation, cannabis/marijuana
- Medical subject headings
- Tobacco Use Disorder, Vaping, Marijuana Abuse
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CounselingBehavioural
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 managementBehavioural
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).
Text-based supportBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| Nicotine treatment | Other | All participants recieve active nicotine treatment for 12 weeks. Receives: Behavioral: Counseling; Behavioral: Contingency management; Behavioral: Text-based support |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Final 7 days of treatment (Weeks 11-12 of tobacco treatment)
Secondary outcomes (1)
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.
Measured: Final 4 weeks of study treatment (Weeks 8-12)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Feb 2024
- Study start13 May 2024
- Primary completion1 Oct 2027 (estimated)
- Study completion3 Jan 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Tobacco Use DisorderStudies of the same condition, open and under way.
- More trials run by Medical University of South CarolinaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 350 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Medical University of South Carolina
- Sponsor type
- University, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Responsible party
- Principal investigator, Erin McClure, Medical University of South Carolina
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06239350
- Sponsor's protocol ID
- Pro00131124
- Other IDs
- 1R01CA276066-01A1
- Acronym
- YouthCAT
- Status last verified
- Nov 2026
- First submitted
- 17 Jan 2024
- Last updated
- 4 Nov 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- 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.
Publications
Dowd AN, Baker NL, Koffarnus MN, Raiff BR, Tomko RL, Gray KM, McClure EA. Evaluating cannabis-nicotine substitution and demand during nicotine cessation treatment in young adults: protocol for a prospective, remote 12-week nicotine cessation trial in the USA. BMJ Open. 2026 Jul 17;16(7):e110992. doi: 10.1136/bmjopen-2025-110992.
PubMed 42468964
Study at a glance
From the registry record, last updated by the sponsor on 4 Nov 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Impact of Cannabis and Tobacco/Nicotine Product Co-use in Young Adults: Prospective Cessation Evaluation and Substitution
- ClinicalTrials.gov ID
- NCT06239350
- Acronym / sponsor ID
- YouthCAT / Pro00131124
- Conditions
- Tobacco Use Disorder, Nicotine Dependence
- Keywords
- tobacco, vaping, cessation, cannabis/marijuana
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 350 participants (estimated)
- Lead sponsor
- Medical University of South CarolinaUniversity, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Study start
- 13 May 2024 (actual)
- Primary completion
- 1 Oct 2027 (estimated)
- Study completion
- 3 Jan 2028 (estimated)
- First posted
- 2 Feb 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Nicotine treatment | Other | Behavioral: Counseling, Behavioral: Contingency management, Behavioral: Text-based supportAll participants recieve active nicotine treatment for 12 weeks. |
Who may qualify
- Ages
- 18 to 25 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (7 listed)
- Between the ages of 18 and 25 years old
- Must use at least one nicotine or tobacco product (nicotine vaping and/or cigarettes) on at least 20 out of the past 30 days for at least the past 3 months
- Must express interest in nicotine cessation (all products)
- Must submit a positive instant-read cotinine sample prior to enrollment
- Must report use of cannabis on at least 10 out of the past 30 days
Key exclusion criteria (4 listed)
- Any significant or acutely unstable medical, psychiatric, or substance use problem that would contraindicate research, interfere with safety, compromise data integrity, or preclude consistent study participation
- Pregnant (self-report) or trying to become pregnant
- Self-reported use of medications with smoking cessation efficacy
- Immediate interest in cannabis cessation or treatment
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| CounselingResearch 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. | Behavioural | Nicotine treatment |
| Contingency managementContingency 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). | Behavioural | Nicotine treatment |
| Text-based supportAll 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. | Behavioural | Nicotine treatment |
Primary outcome
7-day point prevalence nicotine abstinence at the end of treatment (Week 12)
Time frame: Final 7 days of treatment (Weeks 11-12 of tobacco treatment)
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.
1 secondary outcome
Changes in cannabis use during nicotine cessation treatment
Time frame: Final 4 weeks of study treatment (Weeks 8-12)
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Nov 2026.
- Derived from this study: PubMed 42468964Dowd AN, Baker NL, Koffarnus MN, Raiff BR, Tomko RL, Gray KM, McClure EA. Evaluating cannabis-nicotine substitution and demand during nicotine cessation treatment in young adults: protocol for a prospective, remote 12-week nicotine cessation trial in the USA. BMJ Open. 2026 Jul 17;16(7):e110992. doi: 10.1136/bmjopen-2025-110992.
- Individual participant dataSharing planned: 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Counseling, Contingency management and Text-based support in people with Tobacco Use Disorder and Nicotine Dependence, run by Medical University of South Carolina at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 4 Nov 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Elizabeth Chapman (864.898.2992, chapmanb@musc.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
7-day point prevalence nicotine abstinence at the end of treatment (Week 12) (time frame: Final 7 days of treatment (Weeks 11-12 of tobacco treatment)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06239350, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Nov 2026.