NCT01604330

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
323

participants targeted

Target at P75+ for phase_2

Timeline
Completed

Started May 2012

Typical duration for phase_2

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

May 21, 2012

Completed
2 days until next milestone

First Posted

Study publicly available on registry

May 23, 2012

Completed
6 days until next milestone

Study Start

First participant enrolled

May 29, 2012

Completed
2.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2014

Completed
1.1 years until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2015

Completed
Last Updated

September 5, 2025

Status Verified

August 1, 2025

Enrollment Period

2.3 years

First QC Date

May 21, 2012

Last Update Submit

August 29, 2025

Conditions

Alcoholism

Keywords

High dose baclofenAlcoholismAbstinenceLow risk consumptionCraving

Outcome Measures

Primary Outcomes (1)

  • Proportion of abstainer patients and patients with a low risk consumption

    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.

    12 months after the initiation of treatment

Secondary Outcomes (7)

  • Distribution of Efficience dosage of baclofen

    12 months after the initiation of treatment

  • To evaluate the tolerance of baclofen

    12 months after the initiation of treatment

  • To better characterize the alcoholic patients in whom this molecule is effective

    12 months after the initiation of treatment

  • Evolution of patients under treatment

    12 months after the initiation of treatment

  • Cumulative quantity of alcohol drunk in the last month

    12 months after the initiation of treatment

  • +2 more secondary outcomes

Study Arms (2)

Baclofen

EXPERIMENTAL

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: Baclofen

Placebo

PLACEBO COMPARATOR

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.

Drug: Placebo

Interventions

BaclofenDRUG

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.

Baclofen
PlaceboDRUG

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.

Placebo

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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).

You may not qualify if:

  • 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 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Paris Descartes University

Paris, 75014, France

Location

Related Publications (2)

  • 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.

    PMID: 31833590BACKGROUND

  • 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.

    PMID: 33012365DERIVED

MeSH Terms

Conditions

Alcoholism

Interventions

Baclofen

Condition Hierarchy (Ancestors)

Alcohol-Related DisordersSubstance-Related DisordersChemically-Induced DisordersMental Disorders

Intervention Hierarchy (Ancestors)

gamma-Aminobutyric AcidAminobutyratesButyratesAcids, AcyclicCarboxylic AcidsOrganic Chemicals

Study Officials

  • Philippe Jaury, MD, PhD

    University of Paris 5 - Rene Descartes

    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
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 21, 2012

First Posted

May 23, 2012

Study Start

May 29, 2012

Primary Completion

September 1, 2014

Study Completion

October 1, 2015

Last Updated

September 5, 2025

Record last verified: 2025-08

Data Sharing

IPD Sharing
Will not share

Locations

FR(1)