Alcohol Use Disorder Clinical Trial
Official title:
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
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.
Varenicline (Champix®) and bupropion (Zyban®, patent time expired) are approved and marketed
in Europe and US for smoking cessation in nicotine use disorder, and for treatment of major
depression (bupropion). There is clinical evidence of an additive effect of the drug
combination of varenicline and bupropion on smoking cessation. Varenicline has been shown in
two RCTs to reduce also alcohol intake in subjects with AUD. It is hypothesized that
bupropion will enhance the effect of varenicline and that the combined effect size will be
greater than that of approved therapies for AUD. As efficacy endpoint, the trial uses the
alcohol specific biomarker for alcohol intake, phosphatidylethanol in blood (B-PEth). Outcome
will also be measured by self-reported alcohol consumption, the standard effect measure in
AUD trials.This will be the first trial using the biomarker B-PEth as primary outcome
variable. The use of a specific objective marker is expected to increase chances for
detecting treatment effects.
Development phase: II Number of randomized subjects: 380 subjects with AUD. 95 subjects per
treatment arm will be randomized into the study.
Number of sites: Approximately 5 study sites in Sweden
Investigational medicinal products, dosages and administration:
There will be two separate study kits for IMP 1 and IMP 2
Investigational medicinal product 1 (IMP1): Varenicline 1 mg x 2 p.o. daily. The
pharmaceutical formulation will be encapsulated tablets for oral use. Varenicline will be
escalated from 0.5 to 2 mg daily during the first week.
Investigational medicinal product 2 (IMP 2): Bupropion SR 150 mg x 2 p.o. daily. The
pharmaceutical formulation will be encapsulated sustained release (SR) tablets for oral use.
Bupropion will be escalated from 150 to 300 mg daily during the first week.
IMP 1 and IMP 2 are distributed at 7 occasions: Day 0, Day 7, Day 21, Day 35, Day 49, Day 63
and Day 77. The doses and route of administration for varenicline and bupropion are those
approved and recommended as oral formulations for smoking cessation.
The trial comprises 9 study visits over 91 days: Screening visit,Day 0, Day 7, Day 21, Day
35, Day 49, Day 63, Day 77 and Day 91. Randomization is carried out according to block
randomization and eligible subjects are randomized to one of the below described intervention
arms.
The study will be performed in accordance with the study protocol, with the latest version of
the Declaration of Helsinki, in accordance with GCP principles (ICH-GCP E6-R2), and
applicable regulatory requirements in Sweden . The study is approved by competent authority
(the Swedish Medical Product Agency) and the Etics committee. The trial is monitored by an
independent monitor according to GCP principles.
;
Status | Clinical Trial | Phase | |
---|---|---|---|
Recruiting |
NCT04788004 -
Long-term Recovery: Longitudinal Study of Neuro-behavioral Markers of Recovery and Precipitants of Relapse
|
||
Recruiting |
NCT05684094 -
Mechanisms of Risky Alcohol Use in Young Adults: Linking Sleep to Reward- and Stress-Related Brain Function
|
N/A | |
Completed |
NCT03406039 -
Testing the Efficacy of an Online Integrated Treatment for Comorbid Alcohol Misuse and Emotional Problems
|
N/A | |
Completed |
NCT03573167 -
Mobile Phone-Based Motivational Interviewing in Kenya
|
N/A | |
Completed |
NCT04817410 -
ED Initiated Oral Naltrexone for AUD
|
Phase 1 | |
Active, not recruiting |
NCT04267692 -
Harm Reduction Talking Circles for American Indians and Alaska Natives With Alcohol Use Disorders
|
N/A | |
Completed |
NCT03872128 -
The Role of Neuroactive Steroids in Stress, Alcohol Craving and Alcohol Use in Alcohol Use Disorders
|
Phase 1 | |
Recruiting |
NCT06030154 -
Amplification of Positivity for Alcohol Use
|
N/A | |
Active, not recruiting |
NCT05419128 -
Family-focused vs. Drinker-focused Smartphone Interventions to Reduce Drinking-related Consequences of COVID-19
|
N/A | |
Completed |
NCT04564807 -
Testing an Online Insomnia Intervention
|
N/A | |
Completed |
NCT04284813 -
Families With Substance Use and Psychosis: A Pilot Study
|
N/A | |
Completed |
NCT04203966 -
Mental Health and Well-being of People Who Seek Help From Their Member of Parliament
|
||
Recruiting |
NCT05861843 -
Craving Assessment in Patients With Alcohol Use Disorder Using Virtual Reality Exposure
|
||
Terminated |
NCT04404712 -
FAAH Availability in Psychiatric Disorders: A PET Study
|
Early Phase 1 | |
Enrolling by invitation |
NCT04128761 -
Decreasing the Temporal Window in Individuals With Alcohol Use Disorder
|
N/A | |
Not yet recruiting |
NCT06163651 -
Evaluating a One-Year Version of the Parent-Child Assistance Program
|
N/A | |
Not yet recruiting |
NCT06337721 -
Preventing Alcohol Use Disorders and Alcohol-Related Harms in Pacific Islander Young Adults
|
N/A | |
Enrolling by invitation |
NCT02544581 -
Preliminary Analysis of the Soberlink Alcohol Breath Analyzer System's (SABA) Clinical Utility During Aftercare
|
N/A | |
Completed |
NCT02511886 -
A Dose-Escalation Study to Determine the Maximum Tolerated Dose of Arbaclofen Placarbil in Subjects With Alcohol Use Disorder
|
Phase 2 | |
Active, not recruiting |
NCT02185131 -
Double-blind Pilot Trial of Mirtazapine for the Treatment of Co-occurring AD/MDD.
|
Phase 2 |