Does Varenicline Influence Alcohol Consumption in Alcohol Dependent Individuals?

Sponsor

Sahlgrenska University Hospital, Sweden (Other)

Overall Status

Completed

CT.gov ID

NCT00846859

Collaborator

Karolinska University Hospital (Other), Malmö University (Other)

162

Enrollment

3

Locations

2

Arms

22

Duration (Months)

54

Patients Per Site

2.4

Patients Per Site Per Month

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Alcohol Dependence	Drug: varenicline (Champix/Chantix) Drug: placebo for varenicline	Phase 2

Study Design

Study Type:

Interventional

Actual Enrollment :

162 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

Primary Purpose:

Treatment

Official Title:

Does Varenicline Influence Alcohol Consumption in Alcohol Dependent Individuals?

Study Start Date :

Mar 1, 2009

Actual Primary Completion Date :

Aug 1, 2010

Actual Study Completion Date :

Jan 1, 2011

Arms and Interventions

Arm

Intervention/Treatment

Experimental: varenicline

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 Names:

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 Names:

placebo for Champix(R) / Chantix(R)

Outcome Measures

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. []

Eligibility Criteria

Criteria

Ages Eligible for Study:

30 Years to 70 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

No

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Addiction Biology Unit, Beroendekliniken, University of Gothenburg and Sahlgrenska University Hospital	Gothenburg		Sweden	413 45
2	Beroendecentrum, Malmö University Hospital (UMAS), Sweden	Malmö		Sweden	205 02
3	Department of Clinical Neuroscience Section of Dependence Research Magnus Huss Clinic: M4:02 Karolinska University Hospital	Stockholm		Sweden	171 76

Sponsors and Collaborators

Sahlgrenska University Hospital, Sweden
Karolinska University Hospital
Malmö University

Investigators

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

Study Documents (Full-Text)

None provided.

More Information

Publications

Responsible Party:

, ,

ClinicalTrials.gov Identifier:

NCT00846859

Other Study ID Numbers:

GOTABU-BO2

First Posted:

Feb 19, 2009

Last Update Posted:

Jul 21, 2011

Last Verified:

Jul 1, 2011

Keywords provided by , ,

alcohol dependence

nicotine dependence

phosphatidyl ethanol

Additional relevant MeSH terms:

Alcohol Drinking

Study Results

No Results Posted as of Jul 21, 2011