drugset / Trial / NCT04167306
Varenicline and Bupropion for Alcohol Use Disorder
RandomizedParallel-groupQuadruple-blindTreatment
Summary
The COMB study is a randomized double-blind placebo-controlled multicenter trial in Sweden on the efficacy of varenicline and bupropion, in combination and alone, for treatment of alcohol use disorder (AUD). Study design overview: A 13-weeks (91 days) multicenter clinical trial with four parallel groups. 95 subjects per treatment arm will be randomized into the study. 380 subjects with AUD will be randomized in total.
Timeline
- Start
- 2019-03-04
- Primary completion
- 2022-12-15
- Completion
- 2022-12-15
Publications
- Soderpalm B, Lido H, Franck J, Hakansson A, Lindqvist D, Heilig M, Guterstam J, Samuelson M, Askerup B, Wallmark-Nilsson C, de Bejczy A. Efficacy and safety of varenicline and bupropion, in combination and alone, for alcohol use disorder: a randomized, double-blind, placebo-controlled multicentre trial. Lancet Reg Health Eur. 2025 May 13;54:101310. doi: 10.1016/j.lanepe.2025.101310. eCollection 2025 Jul.
- de Bejczy A, Lido H, Soderpalm B. A randomized, double-blind, placebo-controlled, multicentre trial on the efficacy of varenicline and bupropion in combination and alone for treatment of alcohol use disorder: Protocol for the COMB study. PLoS One. 2024 Jan 11;19(1):e0296118. doi: 10.1371/journal.pone.0296118. eCollection 2024.
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Bupropion | Small molecule | 150 mg | Oral |
| Subject | Varenicline | Small molecule | 1 mg | Oral |