Varenicline For Vaping Cessation In Non Smoker Vaper Adolescents

• Status: Not yet recruiting
• Trial end date: 2025-12-01
• Target enrollment: 0
• Participant gender: All

Summary

The Investigators propose a randomized, placebo-controlled trial to test the hypothesis that varenicline added to group behavioral and texting support will be well tolerated and improve vaping cessation rates over behavioral treatment alone in nicotine-dependent adolescents who vape, do not smoke, and want to quit. To do so, the investigators propose to enroll 300 adolescents in Greater Boston meeting these criteria in a double-blind, placebo-controlled, parallel group, study of varenicline up to 1 mg bid for 12 weeks added to 12 weeks of group behavioral and texting support specifically designed for teen vaping cessation.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Massachusetts General Hospital
• Collaborator: National Institute on Drug Abuse (NIDA)
• Treatments: Varenicline

Criteria

Inclusion Criteria:

• Ages 18-23 inclusive

• Report nicotine vaping daily or near daily (≥5 or days per week) for the prior ≥ 3 months, with a positive salivary cotinine >10ng/ml at the enrollment visit.

• Score of ≥4 on the 10-item E-cigarette Dependence Inventory (ECDI)

• Urine Tobacco-specific nitrosamine 4-(methylnitrosamino)-1-(3-pyridyl)-1-butanol (NNAL) at baseline <10pg/ml to confirm self-report of no use of combusted tobacco in the past 2 months.

• Report motivation to quit vaping in the next 30 days

• Able to understand study procedures and read and write in English

• Competent and willing to consent to participation in study procedures.

Exclusion Criteria:

• Smokes more than one cigarette (or other combusted tobacco product) per month on average

• Use of a smoking cessation medication in prior month (nicotine patch, gum, nasal spray, or inhaler, varenicline, bupropion)

• Unwillingness to agree to abstain from using smoking cessation aids during the study

• Unstable medical condition, epilepsy, severe renal impairment

• Lifetime history of schizophrenia or bipolar disorder, inpatient psychiatric hospitalization in the prior 6 months, prior suicide attempt (lifetime), treated for suicidal ideation within 6 months of enrollment, active suicidal ideation or suicidal behavior identified at screening or baseline visits

• Evidence of active problem substance use severe enough in the investigator's opinion to compromise ability to safely participate

• Prior adverse drug reaction to varenicline

• Unwilling to provide saliva or urine samples

• Any other condition or situation that would, in the investigator's opinion, make it unlikely that the participant could adhere safely to the study protocol.