Baclofen for the Treatment of Alcohol Dependence

NCT01266655 | Completed Phase 2

• 1 other identifier: BACLAD
• Study Type: interventional
• Target: 56
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Alcohol Dependence

Outcome Measures

Primary Outcomes (1)

• Total abstinence from alcohol and cumulative abstinence duration

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

Secondary Outcomes (1)

• Number of adverse events

  24 weeks

Study Arms (2)

Baclofen

EXPERIMENTAL

Drug: Baclofen

Placebo

PLACEBO COMPARATOR

Drug: Placebo

Interventions

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.

Baclofen

Placebo DRUG

Placebo

Placebo

Eligibility Criteria

• Age: 18 Years - 64 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Charite University, Berlin, Germany: lead

Study Sites (1)

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

Berlin, State of Berlin, 10117, Germany

Location

Related Publications (1)

• Beck A, Pelz P, Lorenz RC, Charlet K, Geisel O, Heinz A, Wustenberg T, Muller CA. Effects of high-dose baclofen on cue reactivity in alcohol dependence: A randomized, placebo-controlled pharmaco-fMRI study. Eur Neuropsychopharmacol. 2018 Nov;28(11):1206-1216. doi: 10.1016/j.euroneuro.2018.08.507. Epub 2018 Sep 11.

  PMID: 30217552 DERIVED

MeSH Terms

Conditions

Alcoholism

Interventions

Baclofen

Condition Hierarchy (Ancestors)

Alcohol-Related Disorders; Substance-Related Disorders; Chemically-Induced Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

gamma-Aminobutyric Acid; Aminobutyrates; Butyrates; Acids, Acyclic; Carboxylic Acids; Organic Chemicals

Study Officials

• Andreas Heinz, Prof., M.D.

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

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: December 23, 2010
• First Posted: December 24, 2010
• Study Start: February 1, 2011
• Primary Completion: May 1, 2014
• Study Completion: May 1, 2014
• Last Updated: September 5, 2014

Record last verified: 2014-09

Locations

DE (1)