Cannabis and Tobacco Co-use Study

PHASE4CompletedINTERVENTIONAL
Enrollment

181

Participants

Timeline

Start Date

January 28, 2020

Primary Completion Date

June 12, 2024

Study Completion Date

September 13, 2024

Conditions
Tobacco Use Disorder
Interventions
DRUG

Varenicline

Varenicline is a medication approved by the Food and Drug Administration for the treatment of tobacco use disorder among adults (ages 18 and over). In this study, all participants will be administered active medication for the recommended 12 week treatment period. The standard dose titration schedule will be used, which includes 0.5 mg once per day (q.d.) on Days 1-3, 0.5 mg twice per day (b.i.d.) on Days 4-7, and 1.0 mg b.i.d. starting on Day 8. Dosing of 2.0 mg per day will be maintained for the next 11 weeks, for a total of 12 weeks of active treatment for all study participants.

BEHAVIORAL

Contingency Management

Contingency management procedures will be implemented and financial incentives will be provided at weekly visits contingent on tobacco abstinence verified through urinary qualitative cotinine (starting at Week 2). A set amount of $20 per study visit will be delivered based on a negative qualitative urinary cotinine result.

BEHAVIORAL

Counseling

Psychosocial counseling will be administered by trained research staff leading up to the target quit date and throughout the study. Counseling will include motivational enhancement for medication adherence and tobacco cessation. The content of counseling will be skills-based and will focus on enlisting social support, recognizing smoking triggers, managing craving/withdrawal/stress, etc.

Trial Locations (3)

29403

Medical University of South Carolina - Charleston, Charleston

29505

Medical University of South Carolina - Florence, Florence

29671

Behavioral Health Services of Pickens County, Pickens

All Listed Sponsors
collaborator

National Cancer Institute (NCI)

NIH

collaborator

National Institutes of Health (NIH)

NIH

lead

Medical University of South Carolina

OTHER

NCT04228965 - Cannabis and Tobacco Co-use Study | Biotech Hunter | Biotech Hunter