Recruiting

Observational Study

Sponsor:

Medical University of South Carolina

Code:

NCT06239350

Conditions

Tobacco Use Disorder

Nicotine Dependence

Eligibility Criteria

Sex: All

Age: 18 - 25

Healthy Volunteers: Accepted

Interventions

Counseling

Contingency management

Text-based support

Study Details

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.

Conditions

Tobacco Use Disorder

Nicotine Dependence

Study ID

NCT06239350

Start date

May 13, 2024

Status verified date

Jul, 2026

Completion date

Jan 3, 2028

Anticipated

Primary completion date

Oct 1, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18 - 25

Healthy Volunteers: Accepted

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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

Study Design

Enrollment

350 participants

Anticipated

Intervention Model

Single group

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

other: Nicotine treatment

All participants recieve active nicotine treatment for 12 weeks.

Interventions

Counseling

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

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 support

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.

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) ]

Central Contacts and Locations

Central contacts

Elizabeth Chapman

864.898.2992chapmanb@musc.edu

Locations

Medical University of South Carolina - Charleston

Recruiting

Charleston, South Carolina, United States, 29403

Contacts

Ela Williams

843-792-4097williela@musc.edu

More Information

Sponsor

Medical University of South Carolina

Last update posted

Jul 6, 2026

Last verified

Jul, 2026

Keywords

  • tobacco
  • vaping
  • cessation
  • cannabis/marijuana

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Medical University of South Carolina on 2026-07-06.