Does Varenicline Influence Alcohol Consumption in Alcohol Dependent Individuals?

Sahlgrenska University Hospital

Status and phase: Completed; Phase 2

Conditions: Alcohol Dependence

Treatments: Drug: varenicline (Champix/Chantix); Drug: placebo for varenicline

Study type: Interventional

Funder types: Other

Identifiers

NCT00846859

GOTABU-BO2

Details and patient eligibility

About

The aim of the present clinical trial is to investigate whether 14 weeks of treatment with a prescription medication for smoking cessation (European trade name: Champix(R); US trade name: Chantix(R)), can reduce alcohol consumption in alcohol dependent individuals.

Enrollment: 162 patients

Sex: All

Ages: 30 to 70 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

1. Age: 30-70 years at screening
2. Alcohol dependence according to DSM-IV (meeting ≥3 out of 7 criteria)
3. ≥ 20 heavy drinking days (men: ≥ 5 drinks/day, women: ≥4 drinks/day, where 1 std. drink is defined as 12 g ethanol) during the last 60 days
4. Participants must have signed the informed consent

Exclusion criteria

1. Subject to treatment of alcohol withdrawal within 30 days of study initiation
2. Subject to treatment that may affect alcohol consumption including acamprosate, naltrexone, disulfiram, ondansetron, topiramate, SSRIs, varenicline, mirtazapine, rimonabant, methylphenidate or atomoxetine within 3 months of study initiation
3. Subject to treatment of depression within 3 months of study initiation
4. The continuous use of drugs such as codeine, hydroxyzine, alimemazine, benzodiazepines or sedatives (the sporadic use of these compounds is accepted)
5. Any concurrent medication that may affect the results of the trial or is considered to compromise the safety of the participants in the trial
6. History of Delirium Tremens the last 5 years or any history of abstinence-induced seizures
7. Laboratory hepatic values of more than 3 times the upper limit of the normal range or other clinically significant abnormalities in the screening laboratory values.
8. Participants who are pregnant or nursing infant(s), and women of childbearing potential not using a contraceptive method judged by the investigator to be effective.
9. Any ongoing serious psychiatric or somatic disorder
10. Any psychiatric Axel I diagnoses (except for nicotine or alcohol dependence)
11. The concurrent use of illicit drugs based on urine-toxicity test
12. The need for detoxification
13. Diabetes Mellitus Type 1
14. Suicidal risk
15. Homelessness
16. Additional factors that implies to the investigator/physician that the participant will not be completing the study

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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162 participants in 2 patient groups, including a placebo group

varenicline

Experimental group

Treatment:

Drug: varenicline (Champix/Chantix)

placebo

Placebo Comparator group

Treatment:

Drug: placebo for varenicline