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Completed

NCT Number: NCT01266655

Baclofen for the Treatment of Alcohol Dependence

There is first evidence from preclinical and clinical studies for the efficacy of the selective GABA-B receptor agonist baclofen in the treatment of alcohol dependence. The aim of this trial is to evaluate the efficacy and safety of individually titrated high-dose baclofen for relapse prevention in alcohol-dependent patients.

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Key information

Conditions

Alcohol Dependence Alcohol-Related Disorders Alcoholism Chemically-Induced Disorders Mental Disorders Substance-Related Disorders

Age range

18 year–64 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2 / Phase 3

Primary location

Department of Psychiatry, Charité Campus Mitte, Charité - Universitätsmedizin Berlin

Berlin, State of Berlin, 10117, Germany

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Diagnosis of alcohol dependence according to ICD-10 (International Classification of Mental and Behavioural Disorders, 10th revision) and DSM-IV (Diagnostic and Statistical Manual of Mental Disorders, 4th revision) criteria
  • An alcohol intake of at least two heavy drinking days per week on average (men ≥ 5 drinks per day; women ≥ 4 drinks per day) and an average overall consumption of 21 drinks per week or more for men and 14 drinks per week or more for women during the 4 weeks before detoxification (one standard drink is equal to 12 g absolute alcohol)
  • Last alcohol consumption within 7-21 days before randomisation
  • Sufficient German language capabilities

Exclusion criteria

  • Pregnancy and/or currently breastfeeding
  • Clinical significant medical conditions or observed abnormalities
  • Psychiatric illness undergoing treatment with psychoactive drugs
  • Epilepsy or epileptiform convulsions
  • Addiction to drugs other than nicotine

Treatment and study plan

Baclofen

Drug

Baclofen will be administered orally for a maximum of 20 consecutive weeks. For the first 3 days, patients will receive baclofen in a dose of 5 milligrams t.i.d.; subsequently, the daily dose of baclofen will be increased to a maximum of 90 milligrams t.i.d. within 4 weeks. In case of intolerance, dosage can be decreased to a minimum of 10 mg t.i.d.. Patients will receive maximum tolerated dosage of baclofen for 12 weeks. Medication will then gradually be tapered over a maximum of 4 weeks.

Placebo

Drug

Placebo

Primary outcomes

  1. Total abstinence from alcohol and cumulative abstinence duration

    Time frame: 13-16 weeks (depending on the individually tolerated baclofen dose)

Secondary outcomes

  1. Number of adverse events

    Time frame: 24 weeks

Sponsors and collaborators

Lead sponsor

Charite University, Berlin, Germany

Other

Registry information

Official study title

Baclofen for the Treatment of Alcohol Dependence - BACLAD

Acronym: BACLAD

Important dates

Study start
2011
Primary completion
2014
Study completion
2014
First posted
Dec 24, 2010
Registry last updated
Sep 5, 2014

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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