Varenicline for Nicotine Vaping Cessation in Adolescents
Summary
The study will test the hypothesis that varenicline, when added to behavioral and texting support for vaping cessation, will improve vaping abstinence rates in adolescents dependent on vaped nicotine over placebo plus behavioral and texting support for vaping cessation. Approximately 225 adolescents will be randomly assigned to one of three arms (1) varenicline up to 1 mg bid for 12 weeks plus behavioral and texting support for vaping cessation (V+BC), (2) identical appearing placebo plus behavioral and texting support (P+BC) and (3) enhanced usual care (EUC). The primary comparison will be the double-blind, placebo-controlled comparison of vaping cessation rates in those assigned to varenicline vs placebo.
Timeline
- Start
- 2022-06-22
- Primary completion
- 2024-03-20
- Completion
- 2024-05-28
Outcome
Met primary endpoint
registry analysis (superiority test); Double Blind Varenicline (V+BC) vs Double Blind Placebo (P+BC); p <0.001; Odds Ratio (OR) 6.5 (95% CI 3.0 to 14.1); Regression, Logistic NCT05367492 ↗
paper continuous abstinence rates were 51% vs 14% during weeks 9 through 12 (adjusted odds ratio [aOR], 6.5 [95% CI, 3.0-14.1]; P < .001) PMID 40266580 ↗
Publications
- Background Schuster RM, Cather C, Pachas GN, Nielsen L, Iroegbulem V, Dufour J, Potter K, Levy S, Gray KM, Evins AE. A randomized controlled trial of varenicline and brief behavioral counseling delivered by lay counselors for adolescent vaping cessation: Study protocol. Front Psychiatry. 2023 Mar 15;14:1083791. doi: 10.3389/fpsyt.2023.1083791. eCollection 2023.
- Gilman JM, Cather C, Reeder HT, Evohr B, Pachas GN, Gray KM, McClure EA, Schuster RM, Evins AE. Cannabis Use and Nicotine Vaping Cessation Outcomes: A Secondary Analysis of a Randomized Clinical Trial. JAMA Netw Open. 2025 Dec 1;8(12):e2547799. doi: 10.1001/jamanetworkopen.2025.47799.
- Evins AE, Cather C, Reeder HT, Evohr B, Potter K, Pachas GN, Gray KM, Levy S, Rigotti NA, Iroegbulem V, Dufour J, Casottana K, Costello MA, Gilman JM, Schuster RM. Varenicline for Youth Nicotine Vaping Cessation: A Randomized Clinical Trial. JAMA. 2025 Jun 3;333(21):1876-1886. doi: 10.1001/jama.2025.3810.
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Varenicline | Small molecule | 0.5 mg | — |
| Subject | Varenicline | Small molecule | 1 mg | — |