Status:
COMPLETED
Does Varenicline Influence Alcohol Consumption in Alcohol Dependent Individuals?
Lead Sponsor:
Sahlgrenska University Hospital
Collaborating Sponsors:
Karolinska University Hospital
Malmö University
Conditions:
Alcohol Dependence
Eligibility:
All Genders
30-70 years
Phase:
PHASE2
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)),...
Eligibility Criteria
Inclusion
- Age: 30-70 years at screening
- Alcohol dependence according to DSM-IV (meeting ≥3 out of 7 criteria)
- ≥ 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
- Participants must have signed the informed consent
Exclusion
- Subject to treatment of alcohol withdrawal within 30 days of study initiation
- 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
- Subject to treatment of depression within 3 months of study initiation
- The continuous use of drugs such as codeine, hydroxyzine, alimemazine, benzodiazepines or sedatives (the sporadic use of these compounds is accepted)
- Any concurrent medication that may affect the results of the trial or is considered to compromise the safety of the participants in the trial
- History of Delirium Tremens the last 5 years or any history of abstinence-induced seizures
- 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.
- 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.
- Any ongoing serious psychiatric or somatic disorder
- Any psychiatric Axel I diagnoses (except for nicotine or alcohol dependence)
- The concurrent use of illicit drugs based on urine-toxicity test
- The need for detoxification
- Diabetes Mellitus Type 1
- Suicidal risk
- Homelessness
- Additional factors that implies to the investigator/physician that the participant will not be completing the study
Key Trial Info
Start Date :
March 1 2009
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
January 1 2011
Estimated Enrollment :
162 Patients enrolled
Trial Details
Trial ID
NCT00846859
Start Date
March 1 2009
End Date
January 1 2011
Last Update
July 21 2011
Active Locations (3)
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1
Addiction Biology Unit, Beroendekliniken, University of Gothenburg and Sahlgrenska University Hospital
Gothenburg, Sweden, 413 45
2
Beroendecentrum, Malmö University Hospital (UMAS), Sweden
Malmo, Sweden, 205 02
3
Department of Clinical Neuroscience Section of Dependence Research Magnus Huss Clinic: M4:02 Karolinska University Hospital
Stockholm, Sweden, 171 76