CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 388 enrolled
Drug / intervention
Varenicline Tartrate 1 mg b.i.d +3 moredrug
Likely dose
Varenicline Tartrate 1 mg b.i.dfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT04167306
NCT04167306Phase 2Completed

A Randomized, Double-blind, Placebo-controlled Multicenter Trial on the Efficacy of Varenicline and Bupropion in Combination and Alone, for Treatment of Alcohol Use Disorder

Vastra Gotaland Region·interventional·Posted Nov 18, 2019·Updated Jun 7, 2024

In Brief

A Phase 2 clinical trial evaluating Varenicline Tartrate 1 mg b.i.d, Bupropion Hydrochloride 150 mg b.i.d, and 2 other interventions for Alcohol Use Disorder and 2 related conditions. Completed, enrolled 388 participants across 4 sites.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesSweden
Collaborators--

Timeline

Phase 2CompletedFinished
20192020202120222023202420252026
First PostedNov 18, 2019
Enrollment StartMar 4, 2019
Primary CompletionDec 15, 2022
TodayJul 2, 2026
Enrollment to primary: 3.8 yearsPosted 6.6 years ago

Interventions

Varenicline Tartrate 1 mg b.i.ddrug

Capsules for oral use

Bupropion Hydrochloride 150 mg b.i.ddrug

Capsules for oral use

Placebo for vareniclineother

Capsules for oral use

Placebo for bupropionother

Capsules for oral use