Does Varenicline Influence Alcohol Consumption in Alcohol Dependent Individuals?
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT00846859|
Recruitment Status : Completed
First Posted : February 19, 2009
Last Update Posted : July 21, 2011
|Condition or disease||Intervention/treatment||Phase|
|Alcohol Dependence||Drug: varenicline (Champix/Chantix) Drug: placebo for varenicline||Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||162 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)|
|Official Title:||Does Varenicline Influence Alcohol Consumption in Alcohol Dependent Individuals?|
|Study Start Date :||March 2009|
|Actual Primary Completion Date :||August 2010|
|Actual Study Completion Date :||January 2011|
Drug: varenicline (Champix/Chantix)
14 weeks of per oral tablet treatment in an escalating dosing regimen (0.5 mg - 1.0 mg/day; 1 - 2 tablets/day).
Other Name: Champix(R)/Chantix(R)
|Placebo Comparator: placebo||
Drug: placebo for varenicline
14 weeks of per oral tablet treatment in an escalating dosing regimen (1 - 2 tablets/day)
Other Name: placebo for Champix(R) / Chantix(R)
- 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
- 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.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00846859
|Addiction Biology Unit, Beroendekliniken, University of Gothenburg and Sahlgrenska University Hospital|
|Gothenburg, Sweden, 413 45|
|Beroendecentrum, Malmö University Hospital (UMAS), Sweden|
|Malmö, Sweden, 205 02|
|Department of Clinical Neuroscience Section of Dependence Research Magnus Huss Clinic: M4:02 Karolinska University Hospital|
|Stockholm, Sweden, 171 76|
|Study Director:||Elin Löf, PhD||Addiction Biology Unit, University of Gothenburg and Beroendekliniken, Sahlgrenska University Hospital, Sweden|
|Principal Investigator:||Bo Söderpalm, MD, PhD||Addiction Biology Unit, University of Gothenburg and Beroendekliniken, Sahlgrenska University Hospital, Sweden|