E-cigarette Cessation in Adults Who Co-use Cannabis

NCT06688539 | Recruiting Phase 4 DMC FDA Drug

• 2 other identifiers: Pro00136601R37CA237245
• Study Type: interventional
• Target: 105
• Locations: 1 country
• Sites: 3

Brief Summary

The purpose of this study is to better understand tobacco outcomes using a commonly prescribed stop smoking medication (varenicline) and financial incentives for adults who also use cannabis. Varenicline is not FDA approved for e-cigarette cessation, but is FDA approved for cigarette cessation. Investigators are also interested in how cannabis/marijuana and tobacco interact during a tobacco quit attempt. All participants will receive e-cigarette cessation treatment for 12 weeks. To qualify, participants must be between the ages of 18-40 and use both e-cigarettes and cannabis. Participants do not need to be interested in quitting cannabis to qualify. This study is being conducted at three sites: the Medical University of South Carolina in Charleston, SC, Behavioral Health Services in Pickens, SC, and MUSC Lancaster in Lancaster, SC.

Conditions

Nicotine Dependence; Tobacco Use Disorder

Keywords

e-cigarettes; cannabis; treatment

Outcome Measures

Primary Outcomes (1)

• 7-day point prevalence tobacco abstinence at the end of treatment (Week 12)

  7-day point prevalence abstinence from e-cigarettes at the end of treatment (Week 12) will be assessed via biochemical verification (urinary cotinine; ng/ml) and will be compared to cigarette abstinence rates from the parent study (as historical controls)

  Final 7 days of treatment (Week 12)

Secondary Outcomes (2)

• Changes in cannabis use during e-cigarette cessation treatment

  Final 4 weeks of study treatment (Weeks 8-12)

• Cannabis co-use severity on e-cigarette abstinence rates

  Final 7 days of treatment (Week 12)

Study Arms (1)

Co-use group

OTHER

E-cigarette and cannabis co-use group

Drug: Varenicline Pill; Behavioral: Contingency management; Behavioral: Counseling

Interventions

Varenicline Pill DRUG

In this study, all participants will be administered active medication for a 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.

Co-use group

Contingency management BEHAVIORAL

Contingency management procedures will be implemented and financial incentives will be provided at weekly visits contingent on e-cigarette 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.

Co-use group

Counseling BEHAVIORAL

Psychosocial counseling will be administered by trained research staff leading up to the target quit date and throughout the study.

Co-use group

Eligibility Criteria

• Age: 18 Years - 40 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Between the ages of 18 and 40 years old
• Use e-cigarettes daily or near daily in the past month
• Must submit a positive instant-read urine cotinine test at screening (≥ 200 ng/ml)
• Be interested in quitting use of e-cigarettes
• Must be willing to take varenicline for the standard 12-week course of treatment
• Self-reported use of cannabis on at least 10 out of the past 30 days or must submit a positive qualitative urinary cannabinoid test at screening (\> 50 ng/ml)

You may not qualify if:

• Any serious or unstable medical/psychiatric disorder (including severe substance use disorders, other than cannabis or tobacco use disorders) in the past three months that may interfere with study performance
• Use of cigarettes on 10+ days in the past 30
• Currently pregnant or breastfeeding
• Current use of medications with smoking cessation efficacy
• Use of any medications that would interfere with varenicline

Sponsors & Collaborators

• Medical University of South Carolina: lead
• National Cancer Institute (NCI): collaborator

Study Sites (3)

MUSC Charleston

Charleston, South Carolina, 29425, United States

RECRUITING

MUSC Lancaster

Lancaster, South Carolina, 29720, United States

RECRUITING

Behavioral Health Services of Pickens County

Pickens, South Carolina, 29671, United States

RECRUITING

MeSH Terms

Conditions

Tobacco Use Disorder; Vaping; Marijuana Abuse

Interventions

Varenicline; Counseling

Condition Hierarchy (Ancestors)

Substance-Related Disorders; Chemically-Induced Disorders; Mental Disorders; Smoking; Behavior

Intervention Hierarchy (Ancestors)

Benzazepines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds; Quinoxalines; Mental Health Services; Behavioral Disciplines and Activities; Community Health Services; Health Services; Health Care Facilities Workforce and Services

Study Officials

• Erin A McClure, PhD

  Medical University of South Carolina

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Elizabeth Chapman, MA, LPC, LAC, AADC

CONTACT

864.898.2992; chapmanb@musc.edu

Study Design

• Study Type: interventional
• Phase: phase 4
• 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: November 11, 2024
• First Posted: November 14, 2024
• Study Start: February 19, 2025
• Primary Completion (Estimated): June 1, 2026
• Study Completion (Estimated): September 1, 2026
• Last Updated: July 7, 2025

Record last verified: 2025-07

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, ICF

Locations

US (3)