Does Varenicline Influence Alcohol Consumption in Alcohol Dependent Individuals?

July 20, 2011 updated by: Sahlgrenska University Hospital, Sweden
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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

162

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Sweden
      • Gothenburg, Sweden, 413 45
        • Addiction Biology Unit, Beroendekliniken, University of Gothenburg and Sahlgrenska University Hospital
      • Malmö, Sweden, 205 02
        • Beroendecentrum, Malmö University Hospital (UMAS), Sweden
      • Stockholm, Sweden, 171 76
        • Department of Clinical Neuroscience Section of Dependence Research Magnus Huss Clinic: M4:02 Karolinska University Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

30 years to 70 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  1. Age: 30-70 years at screening
  2. Alcohol dependence according to DSM-IV (meeting ≥3 out of 7 criteria)
  3. ≥ 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
  4. Participants must have signed the informed consent

Exclusion Criteria:

  1. Subject to treatment of alcohol withdrawal within 30 days of study initiation
  2. 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
  3. Subject to treatment of depression within 3 months of study initiation
  4. The continuous use of drugs such as codeine, hydroxyzine, alimemazine, benzodiazepines or sedatives (the sporadic use of these compounds is accepted)
  5. Any concurrent medication that may affect the results of the trial or is considered to compromise the safety of the participants in the trial
  6. History of Delirium Tremens the last 5 years or any history of abstinence-induced seizures
  7. 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.
  8. 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.
  9. Any ongoing serious psychiatric or somatic disorder
  10. Any psychiatric Axel I diagnoses (except for nicotine or alcohol dependence)
  11. The concurrent use of illicit drugs based on urine-toxicity test
  12. The need for detoxification
  13. Diabetes Mellitus Type 1
  14. Suicidal risk
  15. Homelessness
  16. Additional factors that implies to the investigator/physician that the participant will not be completing the study

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: QUADRUPLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
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)
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)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
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

Outcome Measure
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.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sahlgrenska University Hospital, Sweden

Collaborators

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

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

March 1, 2009

Primary Completion (ACTUAL)

August 1, 2010

Study Completion (ACTUAL)

January 1, 2011

Study Registration Dates

First Submitted

February 17, 2009

First Submitted That Met QC Criteria

February 17, 2009

First Posted (ESTIMATE)

February 19, 2009

Study Record Updates

Last Update Posted (ESTIMATE)

July 21, 2011

Last Update Submitted That Met QC Criteria

July 20, 2011

Last Verified

July 1, 2011

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • GOTABU-BO2

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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