Does Varenicline Influence Alcohol Consumption in Alcohol Dependent Individuals?

This study has been completed.
Sponsor:
Collaborators:
Karolinska University Hospital
Malmö University
Information provided by:
Sahlgrenska University Hospital, Sweden
ClinicalTrials.gov Identifier:
NCT00846859
First received: February 17, 2009
Last updated: July 20, 2011
Last verified: July 2011
  Purpose

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 Intervention Phase
Alcohol Dependence
Drug: varenicline (Champix/Chantix)
Drug: placebo for varenicline
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Does Varenicline Influence Alcohol Consumption in Alcohol Dependent Individuals?

Resource links provided by NLM:


Further study details as provided by Sahlgrenska University Hospital, Sweden:

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 [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Alcohol consumption as measured by diary and questionnaires: total amount (grams) of consumed alcohol compared to baseline. [ Designated as safety issue: No ]
  • Percentage (and number) of abstaining days compared to baseline. [ Designated as safety issue: No ]
  • Drinks per drinking day compared to baseline. [ Designated as safety issue: No ]
  • Alcohol consumption as measured by alcohol markers in blood compared to baseline. [ Designated as safety issue: No ]
  • Nicotine use in alcohol dependent subjects as measured by diary and questionnaires compared to baseline. [ Designated as safety issue: No ]
  • Compliance as measured by diary and returned medication packages. [ Designated as safety issue: No ]

Enrollment: 162
Study Start Date: March 2009
Study Completion Date: January 2011
Primary Completion Date: August 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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 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)

  Eligibility

Ages Eligible for Study:   30 Years to 70 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
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Please refer to this study by its ClinicalTrials.gov identifier: NCT00846859

Locations
Sweden
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
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
  More Information

Publications:

Responsible Party: Bo Söderpalm/ MD, PhD, sponsor, Addiction Biology Unit, Sahlgrenska University Hospital, Sweden
ClinicalTrials.gov Identifier: NCT00846859     History of Changes
Other Study ID Numbers: GOTABU-BO2
Study First Received: February 17, 2009
Last Updated: July 20, 2011
Health Authority: Sweden: Medical Products Agency

Keywords provided by Sahlgrenska University Hospital, Sweden:
alcohol dependence
nicotine dependence
alcohol abuse
varenicline
Champix
Chantix
smoking
drinking
snuffing
diary
phosphatidyl ethanol
PEth

Additional relevant MeSH terms:
Alcohol Drinking
Alcoholism
Drinking Behavior
Alcohol-Related Disorders
Substance-Related Disorders
Chemically-Induced Disorders
Mental Disorders
Ethanol
Varenicline
Anti-Infective Agents, Local
Anti-Infective Agents
Therapeutic Uses
Pharmacologic Actions
Central Nervous System Depressants
Physiological Effects of Drugs
Central Nervous System Agents
Nicotinic Agonists
Cholinergic Agonists
Cholinergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on August 27, 2014