drugset / Trial / NCT04602494

Varenicline For Nicotine Vaping Cessation In Non Smoker Vaper Adolescents

NCT04602494

RandomizedParallel-groupTriple-blindTreatment

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 among nicotine dependent adolescents who vape, do not smoke regularly, and are willing to try treatment to stop vaping compared to placebo added to group behavioral and texting support. The study will consist of a three-arm randomized, placebo-controlled, parallel-group study of (1) varenicline up to 1 mg bid for 12 weeks added to behavioral and texting support compared with (2) behavioral and texting support and placebo and (3) monitoring only. The primary comparison will be of vaping cessation rates in those assigned to varenicline vs placebo.To do this, the investigators propose to enroll 300 adolescents aged 16-25 who meet eligibility criteria.

Timeline

Start
2020-12-18
Primary completion
2022-06-27
Completion
2022-06-27

Drugs

EvaluationDrugModalityDoseRoute
Subject Varenicline Small molecule 1 mg

Indications