Young Adult Tobacco/Nicotine and Cannabis Co-use
YouthCAT
The Impact of Cannabis and Tobacco/Nicotine Product Co-use in Young Adults: Prospective Cessation Evaluation and Substitution
2 other identifiers
interventional
350
1 country
1
Brief 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. 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started May 2024
Longer than P75 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
January 17, 2024
CompletedFirst Posted
Study publicly available on registry
February 2, 2024
CompletedStudy Start
First participant enrolled
May 13, 2024
CompletedPrimary Completion
Last participant's last visit for primary outcome
October 1, 2027
ExpectedStudy Completion
Last participant's last visit for all outcomes
January 3, 2028
June 12, 2026
June 1, 2026
3.4 years
January 17, 2024
June 10, 2026
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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.
Final 7 days of treatment (Weeks 11-12 of tobacco treatment)
Secondary Outcomes (1)
Changes in cannabis use during nicotine cessation treatment
Final 4 weeks of study treatment (Weeks 8-12)
Other Outcomes (1)
Behavioral economic demand for cannabis during nicotine treatment
Throughout tobacco treatment (Weeks 1-12)
Study Arms (1)
Nicotine treatment
OTHERAll participants recieve active nicotine treatment for 12 weeks.
Interventions
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.
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.
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).
Eligibility Criteria
You may qualify if:
- 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, oral fluid 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Medical University of South Carolina - Charleston
Charleston, South Carolina, 29403, United States
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Associate Professor - Faculty
Study Record Dates
First Submitted
January 17, 2024
First Posted
February 2, 2024
Study Start
May 13, 2024
Primary Completion (Estimated)
October 1, 2027
Study Completion (Estimated)
January 3, 2028
Last Updated
June 12, 2026
Record last verified: 2026-06
Data Sharing
- IPD Sharing
- Will share
- Shared Documents
- STUDY PROTOCOL, ICF, 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.
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.