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Varenicline and Bupropion for Alcohol Use Disorder

NCT04167306 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 388

Last updated 2024-06-07

Study results available
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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.

Conditions

Interventions

DRUG

Varenicline Tartrate 1 mg b.i.d

Capsules for oral use

DRUG

Bupropion Hydrochloride 150 mg b.i.d

Capsules for oral use

OTHER

Placebo for varenicline

Capsules for oral use

OTHER

Placebo for bupropion

Capsules for oral use

Sponsors & Collaborators

  • Vastra Gotaland Region

    lead OTHER_GOV

Principal Investigators

  • Bo Söderpalm, Prof, MD · Sahlgrenska University Hospital, Västra Götaland

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
25 Years
Max Age
70 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2019-03-04
Primary Completion
2022-12-15
Completion
2022-12-15

Countries

  • Sweden

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04167306 on ClinicalTrials.gov