Varenicline and Bupropion for Alcohol Use Disorder

• Status: Recruiting
• Trial end date: 2022-12-30
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: Vastra Gotaland Region
• Treatments: Bupropion; Varenicline

Criteria

Inclusion Criteria:

1. Signed informed consent

2. Blood alcohol level below <0.1‰ (0.1 g/L) at signing informed consent

3. 25-70 years of age at screening

4. Moderate and severe AUD according to DSM-V (meeting ≥4 out of 11 criteria)

5. B-PEth levels of ≥0.5 µmol/L at screening visit (visit 1)

6. Continuous high alcohol consumption over the last 3 months prior to screening as defined by at least 2 HDD per week on a typical week

7. Available phone number for contact

8. Ability to speak and write in Swedish

Exclusion Criteria:

1. Total abstinence between screening and randomization visit

2. Treatment of alcohol withdrawal within 30 days of study initiation

3. Pharmacological treatment within 3 months of study initiation and during the study period that may affect alcohol consumption, including but not exclusive to, varenicline, bupropion, disulfiram, acamprosate, naltrexone, nalmefene, baclofen, topiramate, ondansetron, mirtazapine, methylphenidate, dexamphetamine, atomoxetine, pregabalin, buprenorphine and methadone

4. Non-pharmacological treatment within 3 months of study initiation and during the study period that may affect alcohol consumption

5. Current continuous use of antidepressants, opioid analgesics, benzodiazepines, zopiclone, zolpidem, hydroxyzine, alimemazine, propiomazine, or other sedatives. (The sporadic use of these compounds is accepted.)

6. Any concurrent medication that may affect the results of the trial or is considered to compromise the safety of the participants in the trial. (See SmPCs for possible interactions.)

7. Laboratory hepatic values of >3 times the upper limit of the normal range, creatinine clearance <30 ml/min, or other clinically significant abnormalities in the screening laboratory values

8. Blood pressure ≥180/110 at screening

9. 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.

10. Diabetes mellitus type 1 and diabetes mellitus type 2 in need of insulin treatment

11. Any current psychiatric or somatic disorder or condition that may affect assessments or compromise participant's safety during the trial

12. ASRS- v1.1, part A score ≥4 in the marked cut-off section

13. MADRS score ≥ 20

14. Current depression that is not mild (mild depression is accepted)

15. Suicidality

16. Current illicit drug use based on urine-toxicity test and DUDIT

17. History of delirium tremens or abstinence-induced seizures within 5 years of study initiation

18. Epilepsy or seizures other than alcohol-induced, lifetime

19. Severe sleep disturbances

20. Need of alcohol detoxification

21. Living conditions not appropriate to fulfil study requirements

22. Use of herbal drugs/tea and supplementations possibly affecting outcome or safety

23. Previous randomization in this trial or participation in another trial within 3 months of enrollment into this trial.

24. Additional factors that render the participant unable to complete the study, as judged by the investigator