NCT01604330

Baclofen for the Treatment of Alcohol Drinkers

Alcohol Treatment: Pragmatic Therapeutic Trial Randomized, Double-blind for a Year in Ambulatory Care of Baclofen Versus Placebo.

• Status: Completed
• Phase: Phase 2 / Phase 3
• Study type: Interventional
• Enrollment: 323 (actual)
• Sponsor: Assistance Publique - Hôpitaux de Paris · Academic / Other
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Not accepted

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

Interventions

Type	Name	Description
DRUG	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.
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.

Timeline

• Start date: 2012-05-29
• Primary completion: 2014-09-01
• Completion: 2015-10-01
• First posted: 2012-05-23
• Last updated: 2025-09-05

Locations

1 site across 1 country: France