Back to resultsDoes Varenicline Influence Alcohol Consumption in Alcohol Dependent Individuals?
Primary Purpose
Alcohol Dependence
Status
Completed
Phase
Phase 2
Locations
Sweden
Study Type
Interventional
Intervention
varenicline (Champix/Chantix)
placebo for varenicline
Sponsored by
About this trial
This is an interventional treatment trial for Alcohol Dependence focused on measuring alcohol dependence, nicotine dependence, alcohol abuse, varenicline, Champix, Chantix, smoking, drinking, snuffing, diary, phosphatidyl ethanol, PEth
Eligibility Criteria
Inclusion Criteria:
- 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 Criteria:
- 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
Sites / Locations
- Addiction Biology Unit, Beroendekliniken, University of Gothenburg and Sahlgrenska University Hospital
- Beroendecentrum, Malmö University Hospital (UMAS), Sweden
- Department of Clinical Neuroscience Section of Dependence Research Magnus Huss Clinic: M4:02 Karolinska University Hospital
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Placebo Comparator
Arm Label
varenicline
placebo
Arm Description
Outcomes
Primary Outcome Measures
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
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.
Full Information
NCT ID
NCT00846859
First Posted
February 17, 2009
Last Updated
July 20, 2011
Sponsor
Sahlgrenska University Hospital, Sweden
Collaborators
Karolinska University Hospital, Malmö University
1. Study Identification
Unique Protocol Identification Number
NCT00846859
Brief Title
Does Varenicline Influence Alcohol Consumption in Alcohol Dependent Individuals?
Official Title
Does Varenicline Influence Alcohol Consumption in Alcohol Dependent Individuals?
Study Type
Interventional
2. Study Status
Record Verification Date
July 2011
Overall Recruitment Status
Completed
Study Start Date
March 2009 (undefined)
Primary Completion Date
August 2010 (Actual)
Study Completion Date
January 2011 (Actual)
3. Sponsor/Collaborators
Name of the Sponsor
Sahlgrenska University Hospital, Sweden
Collaborators
Karolinska University Hospital, Malmö University
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Alcohol Dependence
Keywords
alcohol dependence, nicotine dependence, alcohol abuse, varenicline, Champix, Chantix, smoking, drinking, snuffing, diary, phosphatidyl ethanol, PEth
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
162 (Actual)
8. Arms, Groups, and Interventions
Arm Title
varenicline
Arm Type
Experimental
Arm Title
placebo
Arm Type
Placebo Comparator
Intervention Type
Drug
Intervention Name(s)
varenicline (Champix/Chantix)
Other Intervention Name(s)
Champix(R)/Chantix(R)
Intervention Description
14 weeks of per oral tablet treatment in an escalating dosing regimen (0.5 mg - 1.0 mg/day; 1 - 2 tablets/day).
Intervention Type
Drug
Intervention Name(s)
placebo for varenicline
Other Intervention Name(s)
placebo for Champix(R) / Chantix(R)
Intervention Description
14 weeks of per oral tablet treatment in an escalating dosing regimen (1 - 2 tablets/day)
Primary Outcome Measure Information:
Title
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 Measure Information:
Title
Alcohol consumption as measured by diary and questionnaires: total amount (grams) of consumed alcohol compared to baseline.
Title
Percentage (and number) of abstaining days compared to baseline.
Title
Drinks per drinking day compared to baseline.
Title
Alcohol consumption as measured by alcohol markers in blood compared to baseline.
Title
Nicotine use in alcohol dependent subjects as measured by diary and questionnaires compared to baseline.
Title
Compliance as measured by diary and returned medication packages.
10. Eligibility
Sex
All
Minimum Age & Unit of Time
30 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
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 Criteria:
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Elin Löf, PhD
Organizational Affiliation
Addiction Biology Unit, University of Gothenburg and Beroendekliniken, Sahlgrenska University Hospital, Sweden
Official's Role
Study Director
First Name & Middle Initial & Last Name & Degree
Bo Söderpalm, MD, PhD
Organizational Affiliation
Addiction Biology Unit, University of Gothenburg and Beroendekliniken, Sahlgrenska University Hospital, Sweden
Official's Role
Principal Investigator
Facility Information:
Facility Name
Addiction Biology Unit, Beroendekliniken, University of Gothenburg and Sahlgrenska University Hospital
City
Gothenburg
ZIP/Postal Code
413 45
Country
Sweden
Facility Name
Beroendecentrum, Malmö University Hospital (UMAS), Sweden
City
Malmö
ZIP/Postal Code
205 02
Country
Sweden
Facility Name
Department of Clinical Neuroscience Section of Dependence Research Magnus Huss Clinic: M4:02 Karolinska University Hospital
City
Stockholm
ZIP/Postal Code
171 76
Country
Sweden
12. IPD Sharing Statement
Citations:
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19126781
Citation
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Does Varenicline Influence Alcohol Consumption in Alcohol Dependent Individuals?
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