Who is sponsoring BACLOVILLE?

BACLOVILLE is sponsored by Assistance Publique - Hôpitaux de Paris.

What drugs are being tested in BACLOVILLE?

Interventions: Baclofen, Placebo.

What is the status of BACLOVILLE?

BACLOVILLE is currently COMPLETED.

Last reviewed 2025-08-29 · How we verify

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

NCT01604330 Phase 2/Phase 3 COMPLETED

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.

Details

Lead sponsor	Assistance Publique - Hôpitaux de Paris
Phase	Phase 2/Phase 3
Status	COMPLETED
Enrolment	323
Start date	2012-05-29
Completion	2015-10

Conditions

Alcoholism

Interventions

Baclofen
Placebo

Primary outcomes

Proportion of abstainer patients and patients with a low risk consumption — 12 months after the initiation of treatment
Low risk consumption according to the criteria of WHO (World Health Organization). The assessment will be on the declarative of the patient (with autoquestionnaire). It will be compared between the two groups using a Chi-2 test.

Countries

France