Does varenicline influence alcohol consumption in alcohol dependent individuals? - Clinical Trial Champix - Consumption (BO2)

Active, not recruiting

• Conditions: Alcohol dependenceNicotine dependence in alcohol dependent individuals

• Registration Number: EUCTR2007-004954-99-SE
• Lead Sponsor: Göteborg University, Sect. Psyhiatry and Neurochemistry

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2008-06-27
• Last Update Posted: 19 March 2012

Recruitment & Eligibility

• Status: Not Recruiting
• Sex: All
• Target Recruitment: Not specified

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

Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range

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, mirtazepine, 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 hydroxizin, alimemazin, 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
12) The need for detoxification
13) Diabetes Mellitus Type 1
14) Suicidal risk
15) Additional factors that implies to the investigator/physician that the participant will not be completing the study

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified