RECRUITING

Cannabis-Tobacco Co-Use Treatment Study

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

The purpose of the RECLAIM study is to evaluate the effectiveness of varenicline (sometimes known as Chantix) compared to placebo (an inactive substance) for the treatment of cigarettes and cannabis (marijuana). Varenicline is not FDA approved for the combination treatment of cigarette abstinence and cannabis reduction or abstinence. All participants will also receive counseling and access to online treatment modules during a quit attempt for cigarettes and a reduction attempt for cannabis. 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. To qualify, participants must be 18 or older, live in South Carolina, use cigarettes and cannabis, and are interested in quitting cigarettes and reducing cannabis.

Official Title

Randomized Controlled Trial of Varenicline to Treat Tobacco and Cannabis Co-Use (RECLAIM)

Quick Facts

Study Start:2025-05-06
Study Completion:2029-01-01
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT06883162

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:Yes
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. 1. Ages 18 and over (no upper age limit)
  2. 2. Must smoke at least 5 tobacco cigarettes per day on at least 20 out of the past 30 days for the past 3 months
  3. 3. Must express interest in quitting tobacco
  4. 4. Must express interest in cannabis reduction and/or cessation
  5. 5. Must submit a positive instant-read test for cotinine and cannabis prior to enrollment
  6. 6. Must self-report cannabis use (THC-dominant products) on at 3 days per week out of the past 30 days
  7. 7. Must be willing to take varenicline or placebo for 12 weeks
  8. 8. Must reside in South Carolina
  1. 1. Any significant or acutely unstable medical, psychiatric, or substance use problem (including clinically significant disorders) that would contraindicate research, interfere with safety, compromise data integrity, or preclude consistent study participation
  2. 2. Pregnant or trying to become pregnant
  3. 3. Use of medications with smoking cessation efficacy
  4. 4. Regular use of e-cigarettes or other tobacco products (\<10 days in the past month)
  5. 5. Self-reported use of cannabis exclusively for medical purposes

Contacts and Locations

Study Contact

Erin Mcclure
CONTACT
843-792-7192
mccluree@musc.edu
Elizabeth Chapman
CONTACT
864-898-2992
chapmanb@musc.edu

Principal Investigator

Erin Mcclure
PRINCIPAL_INVESTIGATOR
Medical University of South Carolina

Study Locations (Sites)

Medical University of South Carolina - Charleston
Charleston, South Carolina, 29403
United States

Collaborators and Investigators

Sponsor: Medical University of South Carolina

  • Erin Mcclure, PRINCIPAL_INVESTIGATOR, Medical University of South Carolina

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2025-05-06
Study Completion Date2029-01-01

Study Record Updates

Study Start Date2025-05-06
Study Completion Date2029-01-01

Terms related to this study

Additional Relevant MeSH Terms

  • Tobacco Use Disorder
  • Tobacco Use Cessation
  • Cannabis Use
  • Cannabis Use Disorder
  • Marijuana Use