Recruiting

E-cigarette Cessation

Sponsor:

Medical University of South Carolina

Code:

NCT06688539

Conditions

Nicotine Dependence

Tobacco Use Disorder

Eligibility Criteria

Sex: All

Age: 18 - 40

Healthy Volunteers: Accepted

Interventions

Varenicline Pill

Contingency management

Counseling

Study Details

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

Study ID

NCT06688539

Start date

Feb 19, 2025

Status verified date

Jun, 2026

Completion date

Jun 1, 2027

Anticipated

Primary completion date

Mar 1, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18 - 40

Healthy Volunteers: Accepted

Inclusion Criteria:

  • 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)

Exclusion Criteria:

  • 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

Study Design

Enrollment

105 participants

Anticipated

Intervention Model

Single group

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

other: Co-use group

E-cigarette and cannabis co-use group

Interventions

Varenicline Pill

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.

Contingency management

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.

Counseling

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

Primary outcome measure

  • 7-day point prevalence tobacco abstinence at the end of treatment (Week 12) [ Time Frame: Final 7 days of treatment (Week 12) ]

Central Contacts and Locations

Central contacts

Elizabeth Chapman, MA, LPC, LAC, AADC

864.898.2992chapmanb@musc.edu

Locations

MUSC Charleston

Recruiting

Charleston, South Carolina, United States, 29425

Contacts

Ela Williams

843-497-4092williela@musc.edu

Principal Investigator:

Erin A McClure, PhD

MUSC Lancaster

Recruiting

Lancaster, South Carolina, United States, 29720

Contacts

Elizabeth Chapman

864-898-2992chapmanb@musc.edu

Behavioral Health Services of Pickens County

Recruiting

Pickens, South Carolina, United States, 29671

Contacts

Elizabeth Chapman, LPC

864-898-2992chapmanb@musc.edu

More Information

Sponsor

Medical University of South Carolina

Last update posted

Jun 12, 2026

Last verified

Jun, 2026

Keywords

  • e-cigarettes
  • cannabis
  • treatment

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 2026-06-12.