Home
Search
Study Topics
Glossary
|
|
|
|
|
Sponsors and Collaborators: |
Sahlgrenska University Hospital, Sweden Karolinska University Hospital Malmö University Hospital, Sweden |
---|---|
Information provided by: | Sahlgrenska University Hospital, Sweden |
ClinicalTrials.gov Identifier: | NCT00846859 |
The aim of the present clinical trial is to investigate whether 14 weeks of treatment with a prescription medication for smoking cessation, Champix(R)/Chantix(R), can reduce alcohol consumption in alcohol dependent individuals.
Condition | Intervention | Phase |
---|---|---|
Alcohol Dependence |
Drug: varenicline Drug: placebo for varenicline |
Phase II |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Placebo Control, Parallel Assignment, Efficacy Study |
Official Title: | Does Varenicline Influence Alcohol Consumption in Alcohol Dependent Individuals? |
Estimated Enrollment: | 162 |
Study Start Date: | March 2009 |
Estimated Study Completion Date: | July 2011 |
Estimated Primary Completion Date: | July 2011 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
---|---|
varenicline: Experimental |
Drug: varenicline
14 weeks of per oral tablet treatment in an escalating dosing regimen (0.5 mg - 1.0 mg/day; 1 - 2 tablets/day).
|
placebo: Placebo Comparator |
Drug: placebo for varenicline
14 weeks of per oral tablet treatment in an escalating dosing regimen (1 - 2 tablets/day)
|
Ages Eligible for Study: | 30 Years to 70 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contact: Elin Löf, PhD | +46-31-342 ext 4223 | elin.lof@neuro.gu.se |
Contact: Andrea deBejczy, MD | +46-31+342 ext 2160 | andrea.deBejczy@neuro.gu.se |
Sweden | |
Addiction Biology Unit, Beroendekliniken, University of Gothenburg and Sahlgrenska University Hospital | Recruiting |
Gothenburg, Sweden, 413 45 | |
Contact: Elin Löf, PhD elin.lof@neuro.gu.se | |
Sub-Investigator: Elin Löf, PhD | |
Sub-Investigator: Andrea deBejczy, MD | |
Principal Investigator: Bo Söderpalm, MD, PhD | |
Department of Clinical Neuroscience Section of Dependence Research Magnus Huss Clinic: M4:02 Karolinska University Hospital | Not yet recruiting |
Stockholm, Sweden, 171 76 | |
Contact: Anders Hammarberg anders.hammarberg@ki.se | |
Sub-Investigator: Anders Hammarberg | |
Principal Investigator: Johan Franck, MD, PhD | |
Beroendecentrum, Malmö University Hospital (UMAS), Sweden | Not yet recruiting |
Malmö, Sweden, 205 02 | |
Contact: Therése Grahn therese.grahn@skane.se | |
Sub-Investigator: Therese Grahn | |
Principal Investigator: Gulber Asanovska, MD |
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 |
Responsible Party: | Addiction Biology Unit, Sahlgrenska University Hospital, Sweden ( Bo Söderpalm/ MD, PhD, sponsor ) |
Study ID Numbers: | GOTABU-BO2 |
Study First Received: | February 17, 2009 |
Last Updated: | March 18, 2009 |
ClinicalTrials.gov Identifier: | NCT00846859 History of Changes |
Health Authority: | Sweden: Medical Products Agency |
alcohol dependence nicotine dependence alcohol abuse varenicline Champix Chantix |
smoking drinking snuffing diary phosphatidyl ethanol PEth |
Nicotine polacrilex Smoking Nicotine Mental Disorders Alcoholism Substance-Related Disorders |
Drinking Behavior Disorders of Environmental Origin Alcohol-Related Disorders Alcohol Drinking Varenicline Ethanol |
Mental Disorders Alcoholism Substance-Related Disorders Drinking Behavior |
Disorders of Environmental Origin Alcohol-Related Disorders Alcohol Drinking |