Smoking Cessation Study In Healthy Adolescent Smokers
Summary
The study is designed to see if varenicline combined with age appropriate (adolescent) smoking cessation counseling will help teens quit smoking.
Timeline
- Start
- 2011-04
- Primary completion
- 2018-01
- Completion
- 2018-01
Outcome
Missed primary endpoint
registry analysis (superiority test); Varenicline High Dose vs Placebo; p = 0.6337; Odds Ratio (OR) 1.18 (95% CI 0.59 to 2.37); NCT01312909 ↗
registry analysis (superiority test); Varenicline Low Dose vs Placebo; p = 0.1114; Odds Ratio (OR) 1.73 (95% CI 0.88 to 3.39); NCT01312909 ↗
paper Abstinence rates between high-dose varenicline and placebo groups (odds ratio [OR] 1·18 [95% CI 0·59-2·37]; p=0·63) and between low-dose varenicline and placebo groups (1·73 [0·88-3·39]; p=0·11) did not differ significantly. PMID 32979939 ↗
Publications
- Fediuk DJ, Sweeney K, Sahasrabudhe V, McRae T, Byon W. Population pharmacokinetics and exposure-response analyses of varenicline in adolescent smokers. CPT Pharmacometrics Syst Pharmacol. 2021 Jul;10(7):769-781. doi: 10.1002/psp4.12645. Epub 2021 Jun 17.
- Gray KM, Rubinstein ML, Prochaska JJ, DuBrava SJ, Holstein AR, Samuels L, McRae TD. High-dose and low-dose varenicline for smoking cessation in adolescents: a randomised, placebo-controlled trial. Lancet Child Adolesc Health. 2020 Nov;4(11):837-845. doi: 10.1016/S2352-4642(20)30243-1. Epub 2020 Sep 25.
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Varenicline | Small molecule | 0.5 mg | Oral |
| Subject | Varenicline | Small molecule | 1 mg | Oral |
Indications
No indication recorded.