Baclofen for the Treatment of Alcohol Drinkers

NCT ID: NCT01604330

Last Updated: 2025-09-05

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2/PHASE3
• Total Enrollment: 323 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2012-05-29
• Study Completion Date: 2015-10-31

Brief Summary

The main objective of this study is to show the effectiveness to a year of baclofen compared to placebo, on the proportion of patients with a low risk alcohol consumption or no, according to the WHO standards.

Detailed Description

Baclofen, a gamma-aminobutyric acid 'B-receptor' agonist, has long been used to treat spasticity from neurological diseases, at a dose of 30-90 mg/day. It appears today to be a promising but controversial candidate for treating alcoholic patients (Enserick, 2011) by reducing or even suppressing their craving to drink. A few case reports (Ameisen, 2005; Bucknam, 2007; Dore et al., 2011) and a retrospective study (Rigal et al, 2012) suggest that some patients might respond favorably to baclofen at higher doses than 90 mg/day. This is a randomized controlled trial versus placebo testing such doses.

An extraction of patients DNA and a genetic analysis will be done after the end of the trial. In a gene candidate approach, the association of several genes with the efficiency of the treatment and its side effects, based on the literature, will be investigated using micro-array technology.

Conditions

Alcoholism

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: QUADRUPLE

Study Groups

Baclofen

Baclofen will be administered orally for a maximum of 52 consecutive weeks. For the first 3 days, patients will receive baclofen in a dose of 5 milligrams three times a day; then the dose of baclofen will be increased to a maximum of 300 milligrams a day. In case of intolerance, dosage can be decreased.

Group Type: EXPERIMENTAL

Baclofen

Intervention Type: DRUG

Baclofen will be administered orally for a maximum of 52 consecutive weeks. For the first 3 days, patients will receive baclofen in a dose of 5 milligrams three times a day; then the dose of baclofen will be increased to a maximum of 300 milligrams a day. In case of intolerance, dosage can be decreased.

Placebo

Sugar pill will be administered orally for a maximum of 52 consecutive weeks. For the first 3 days, patients will receive sugar pill in a dose of 5 milligrams three times a day; then the dose of sugar pill will be increased to a maximum of 300 milligrams a day. In case of intolerance, dosage can be decreased.

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: DRUG

Sugar pill will be administered orally for a maximum of 52 consecutive weeks. For the first 3 days, patients will receive sugar pill in a dose of 5 milligrams three times a day; then the dose of sugar pill will be increased to a maximum of 300 milligrams a day. In case of intolerance, dosage can be decreased.

Interventions

Baclofen

Baclofen will be administered orally for a maximum of 52 consecutive weeks. For the first 3 days, patients will receive baclofen in a dose of 5 milligrams three times a day; then the dose of baclofen will be increased to a maximum of 300 milligrams a day. In case of intolerance, dosage can be decreased.

Intervention Type: DRUG

Placebo

Sugar pill will be administered orally for a maximum of 52 consecutive weeks. For the first 3 days, patients will receive sugar pill in a dose of 5 milligrams three times a day; then the dose of sugar pill will be increased to a maximum of 300 milligrams a day. In case of intolerance, dosage can be decreased.

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

• Patient coming for a problem with alcohol (alcohol at high risk during the past three months (at least two times during each month) according to the WHO standards;. i.e.: in women more than 40 g per day or 280 g per week or more of 40 g at once; the man more than 60 g per day or 420 g per week or more than 60 g in once, and expressing the desire to be abstinent or to have a consumption to low level of risk).
• Volunteer to participate in the trial and having given his consent written after appropriate information
• Patient having no treatment for the maintenance of abstinence (acamprosate, naltrexone) and the prevention of relapse (disulfiram) for at least 15 days before the beginning of the trial
• Patient informed about the possibility of drowsiness in relation to the treatment and the associated risks to drive vehicles (motorized or not), the use of machines (including domestic use or recreation) and the execution of tasks requiring attention and precision
• Including woman of childbearing age (but taking effective contraception).

Exclusion Criteria

• Patient taking already baclofen or having taken baclofen
• Patient pregnant, lactating, or childbearing years in the absence of effective contraception
• Patient with porphyria
• Patient with Parkinson's disease
• Patient with severe psychiatric pathology (psychosis, including schizophrenia and bipolar disorders) that can compromise the observance
• Patient with organic disease serious enough to not to allow its inclusion in the study according to the opinion of the investigator
• Patient homeless
• Patient without social cover
• Patient unable to properly follow-up book, cannot commit to one year of follow-up
• Patient with a contraindication to taking baclofen (intolerance to gluten by the presence of wheat starch
• Patient with a severe intolerance known about the lactose

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Société de Formation Thérapeutique du Généraliste

OTHER

Sponsor Role: collaborator

Cochin Hospital, Paris, Professor Claire Le Jeunne - Chief Scientist

UNKNOWN

Sponsor Role: collaborator

URC-CIC Paris Descartes Necker Cochin

OTHER

Sponsor Role: collaborator

Assistance Publique - Hôpitaux de Paris

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Philippe Jaury, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

University of Paris 5 - Rene Descartes

Locations

Paris Descartes University

Paris, , France

Countries

France

References

Rigal L, Sidorkiewicz S, Treluyer JM, Perrodeau E, Le Jeunne C, Porcher R, Jaury P. Titrated baclofen for high-risk alcohol consumption: a randomized placebo-controlled trial in out-patients with 1-year follow-up. Addiction. 2020 Jul;115(7):1265-1276. doi: 10.1111/add.14927. Epub 2020 Feb 16.

Reference Type: BACKGROUND

PMID: 31833590 (View on PubMed)

Braillon A, Naudet F. Pharmacotherapies for Alcohol Use Disorder: Over Both Sides of the Atlantic Ocean. Mayo Clin Proc. 2020 Oct;95(10):2294-2295. doi: 10.1016/j.mayocp.2020.08.005. No abstract available.

Reference Type: DERIVED

PMID: 33012365 (View on PubMed)

Other Identifiers

2011-005787-17

Identifier Type: EUDRACT_NUMBER

Identifier Source: secondary_id

P110112

Identifier Type: -

Identifier Source: org_study_id