Baclofen for the Treatment of Alcohol Drinkers

PHASE2/PHASE3CompletedINTERVENTIONAL
Enrollment

323

Participants

Timeline

Start Date

May 29, 2012

Primary Completion Date

September 30, 2014

Study Completion Date

October 31, 2015

Conditions
Alcoholism
Interventions
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.

Trial Locations (1)

75014

Paris Descartes University, Paris

All Listed Sponsors
collaborator

Société de Formation Thérapeutique du Généraliste

OTHER

collaborator

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

UNKNOWN

collaborator

URC-CIC Paris Descartes Necker Cochin

OTHER

lead

Assistance Publique - Hôpitaux de Paris

OTHER

NCT01604330 - Baclofen for the Treatment of Alcohol Drinkers | Biotech Hunter | Biotech Hunter