Young Adult Tobacco/Nicotine and Cannabis Co-use
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-25
SponsorMedical University of South Carolina
About this trial
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.
Eligibility criteria
This trial accepts healthy volunteersQualifiers
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
Disqualifiers
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 design
Design model
Single group
Treatments tested in this trial
Counseling
BehavioralResearch 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
BehavioralContingency 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 support
BehavioralAll 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.
Treatment groups
350 Participants
are divided into 1 treatment groupGroup A: Nicotine treatmentOther 3 interventions
Trial outcomes
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.
Time frame
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.
Time frame
Final 4 weeks of study treatment (Weeks 8-12)Other outcomes
1
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)Sponsors and contacts
Click on the lead sponsor to view all of their trials.
Medical University of South Carolina
Lead sponsor
National Cancer Institute (NCI)
Collaborator
Source ClinicalTrials.gov