E-cigarette Cessation in Adults Who Co-use Cannabis

Part of paid clinical trials in Charleston, South Carolina.

Sponsor
Medical University of South Carolina
Study ID
NCT06688539
Phase
PHASE4
Status
Recruiting
Apply to this trial

Conditions

  • Nicotine Dependence
  • Tobacco Use Disorder

Eligibility Criteria

Sex
ALL
Age
18 Years - 40 Years
Healthy Volunteers
Accepted

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

Study Details

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.

Key Dates

Start date
Feb 19, 2025
Status verified
Jul 2025
Primary completion
Jun 1, 2026
Completion
Sep 1, 2026

Study Design

Enrollment
105 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Other: Co-use group
    E-cigarette and cannabis co-use group

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

Locations (3)

FacilityCityStateZIPSite coordinators
MUSC CharlestonCharlestonSouth Carolina29425
Ela Williams
[email protected]
843-497-4092
Erin A McClure, PhD (PRINCIPAL_INVESTIGATOR)
MUSC LancasterLancasterSouth Carolina29720
Frances Hakes
[email protected]
864-898-2992
Behavioral Health Services of Pickens CountyPickensSouth Carolina29671
Elizabeth Chapman, LPC
[email protected]
864-898-2992

Find similar trials in Charleston, SC

By research site
MUSC Charleston· Charleston, SCMUSC Lancaster· Lancaster, SCBehavioral Health Services of Pickens County· Pickens, SC

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