Does Varenicline Influence Alcohol Consumption in Alcohol Dependent Individuals?

Phase 2

Completed

• Conditions: Alcohol Dependence
• Interventions: Drug: varenicline (Champix/Chantix); Drug: placebo for varenicline

• Registration Number: NCT00846859
• Lead Sponsor: Sahlgrenska University Hospital, Sweden

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2009-02-17
• Study First Submitted QC: 2009-02-17
• Study First Posted: 2009-02-19
• Study Start: 2009-03
• Primary Completion: 2010-08
• Study Completion: 2011-01
• Status Verified: 2011-07
• Last Update Submitted: 2011-07-20
• Last Update Posted: 2011-07-21

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 162

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
varenicline	varenicline (Champix/Chantix)	-
placebo	placebo for varenicline	-

Primary Outcome Measures

Name	Time	Method
Alcohol consumption as measured by diary and questionnaires: the number of heavy drinking days (as percentage) defined as ≥5 standard drinks per day for men and ≥4 standard drinks per day for women

Secondary Outcome Measures

Name	Time	Method
Alcohol consumption as measured by diary and questionnaires: total amount (grams) of consumed alcohol compared to baseline.
Percentage (and number) of abstaining days compared to baseline.
Drinks per drinking day compared to baseline.
Alcohol consumption as measured by alcohol markers in blood compared to baseline.
Nicotine use in alcohol dependent subjects as measured by diary and questionnaires compared to baseline.
Compliance as measured by diary and returned medication packages.

Trial Locations

Locations (3)

Beroendecentrum, Malmö University Hospital (UMAS), Sweden; 🇸🇪 Malmö, Sweden

Addiction Biology Unit, Beroendekliniken, University of Gothenburg and Sahlgrenska University Hospital; 🇸🇪 Gothenburg, Sweden

Department of Clinical Neuroscience Section of Dependence Research Magnus Huss Clinic: M4:02 Karolinska University Hospital; 🇸🇪 Stockholm, Sweden