Phase 2
Completed N=388
Varenicline and Bupropion for Alcohol Use Disorder
Alcohol Use Disorder · Alcoholism · alcohol dependence
Source: ClinicalTrials.gov NCT04167306 ↗
Enrolled (actual)
388
Serious AEs
2.9%
Results posted
Jun 2024
Primary outcomePrimary: Alcohol Consumption as Measured by Phosphatidylethanol (PEth) in Blood — -0.406; -0.417; -0.315; 0.250 mikromol/litre
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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Alcohol Consumption as Measured by Phosphatidylethanol (PEth) in Blood |
-0.406; -0.417; -0.315; 0.250 | — |
| PRIMARY Alcohol Consumption as Measured by Heavy Drinking Days (HDD) |
-0.322; -0.314; -0.298; -0.217 | — |
| SECONDARY CDT |
— | — |
| SECONDARY GGT |
— | — |
| SECONDARY Self-reported Alcohol Consumption Measured by Time-lime-follow-back |
— | — |
| SECONDARY Alcohol Use Identification Test |
— | — |
| SECONDARY Self-reported Alcohol Craving |
— | — |
| SECONDARY Nicotine Use |
— | — |
| SECONDARY The Temporal Experience of Pleasure Scale (TEPS) |
— | — |
| SECONDARY The Continous Performance Test + Activity Test |
— | — |
| SECONDARY Plasma Concentration of Varenicline (ng/ml) |
— | — |
| SECONDARY Plasma Concentration of Bupropion (ng/ml) |
— | — |
Eligibility Criteria
Inclusion Criteria
- Signed informed consent
- Blood alcohol level below 3 times the upper limit of the normal range, creatinine clearance <30 ml/min, or other clinically significant abnormalities in the screening laboratory values
- Blood pressure ≥180/110 at screening
- Pregnancy, breast-feeding and for premenopausal women, not using one of the contraceptive methods oral contraceptive, intrauterine contraceptive device (copper or hormonal) or subcutaneous inplant.
- Diabetes mellitus type 1 and diabetes mellitus type 2 in need of insulin treatment
- Any current psychiatric or somatic disorder or condition that may affect assessments or compromise participant's safety during the trial
- ASRS- v1.1, part A score ≥4 in the marked cut-off section
- MADRS score ≥ 20
- Current depression that is not mild (mild depression is accepted)
- Suicidality
- Current illicit drug use based on urine-toxicity test and DUDIT
- History of delirium tremens or abstinence-induced seizures within 5 years of study initiation
- Epilepsy or seizures other than alcohol-induced, lifetime
- Severe sleep disturbances
- Need of alcohol detoxification
- Living conditions not appropriate to fulfil study requirements
- Use of herbal drugs/tea and supplementations possibly affecting outcome or safety
- Previous randomization in this trial or participation in another trial within 3 months of enrollment into this trial.
- Additional factors that render the participant unable to complete the study, as judged by the investigator
Data sourced from ClinicalTrials.gov (NCT04167306). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.