Varenicline and Bupropion for Alcohol Use Disorder

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

Outcome

Met primary endpoint

paper Varenicline + Bupropion reduced B-PEth (Cohen's d [d] = 0·39, p = 0·004) PMID 40487775 ↗

paper and %HDD (d = 0·31, p = 0·008) vs Placebo + Placebo. PMID 40487775 ↗

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

Indications