Baclofen for the Treatment of Alcohol Drinkers - Full Text View

Purpose

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.

Condition	Intervention	Phase
Alcoholism	Drug: Baclofen Drug: Placebo	Phase 2 Phase 3

Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor) Primary Purpose: Treatment
Official Title:	Alcohol Treatment: Pragmatic Therapeutic Trial Randomized, Double-blind for a Year in Ambulatory Care of Baclofen Versus Placebo.

Resource links provided by NLM:

MedlinePlus related topics: Alcoholism

Drug Information available for: Baclofen

U.S. FDA Resources

Further study details as provided by Assistance Publique - Hôpitaux de Paris:

Primary Outcome Measures:

Proportion of abstainer patients and patients with a low risk consumption [ Time Frame: 12 months after the initiation of treatment ] [ Designated as safety issue: Yes ]
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.

Secondary Outcome Measures:

Distribution of Efficience dosage of baclofen [ Time Frame: 12 months after the initiation of treatment ] [ Designated as safety issue: Yes ]
Published studies indicate that the average dose would be about 140 mg per day without, a priori, report with the weight of the patient. Animal studies show an optimal dose of 3 mg/kg.
To evaluate the tolerance of baclofen [ Time Frame: 12 months after the initiation of treatment ] [ Designated as safety issue: Yes ]
To try, if possible, to differentiate which is due to the molecule, which is due to the stop of drinking alcohol and which is due to the alcohol-baclofen potentiation and looking for all the side effects including at high dosages.
To better characterize the alcoholic patients in whom this molecule is effective [ Time Frame: 12 months after the initiation of treatment ] [ Designated as safety issue: No ]
By using the anxiety/depression HAD scale. By using the scale of craving (Obsessive Compulsive Drinking Scale). By using the DSM - IV for the dependency.
Evolution of patients under treatment [ Time Frame: 12 months after the initiation of treatment ] [ Designated as safety issue: No ]
At each consultation, the consumption self-assessment questionnaire is analysed with the patient (book of follow-up) and missing data are sought and completed.

To describe the evolution of patients under treatment from the point of view of the total consumption of alcohol, the monthly average consumption, the number of days of abstinence, the number of "heavy drinking days".
Cumulative quantity of alcohol drunk in the last month [ Time Frame: 12 months after the initiation of treatment ] [ Designated as safety issue: No ]
To analyse the cumulative quantity of alcohol drunk by the patient during the last month of treatment
Quality of life during treatment [ Time Frame: at Day 1 and 12 months after the initiation of treatment ] [ Designated as safety issue: No ]
To assess the quality of life during treatment by using the scale SF36 at the beginning and at the end of the study.
Evolution of biology [ Time Frame: At day one, 6 months and 12 months after the initiation of treatment ] [ Designated as safety issue: No ]
To study the evolution of biology, including liver, compared to the declaration made by the patient from his response to treatment. Biological examinations will be performed at the beginning, at 6 month and at the end of the trial.

Estimated Enrollment:	320
Study Start Date:	May 2012
Estimated Study Completion Date:	December 2014
Estimated Primary Completion Date:	July 2014 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Experimental: 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: 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.
Placebo Comparator: 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.	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.

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.

Eligibility

Ages Eligible for Study:	18 Years to 65 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT01604330

Contacts

Contact: Philippe JAURY, MD, PhD	+33144 41 23 60	philippe.jaury@parisdescartes.fr
Contact: Laurence LECOMTE, PhD	+33 1 71 19 64 94	laurence.lecomte@nck.aphp.fr

Locations

France
Paris Descartes University	Recruiting
Paris, France, 75014
Contact: Philippe Jaury, MD, PhD +331 44 41 23 60 philippe.jaury@parisdescartes.fr

Sponsors and Collaborators

Assistance Publique - Hôpitaux de Paris

Société de Formation Thérapeutique du Généraliste

Professor Claire Le Jeunne - Chief Scientist (Hôtel Dieu Hospital, Paris)

Investigators

Principal Investigator:

Philippe Jaury, MD, PhD

Paris Descartes University

More Information

No publications provided

Responsible Party:	Assistance Publique - Hôpitaux de Paris
ClinicalTrials.gov Identifier:	NCT01604330 History of Changes
Other Study ID Numbers:	P110112, 2011-005787-17
Study First Received:	May 21, 2012
Last Updated:	March 26, 2013
Health Authority:	France: Ministry of Health

Keywords provided by Assistance Publique - Hôpitaux de Paris:

High dose baclofen
Alcoholism
Abstinence
Low risk consumption
Craving

Additional relevant MeSH terms:

Alcoholism
Alcohol-Related Disorders
Substance-Related Disorders
Mental Disorders
Baclofen
GABA-B Receptor Agonists
GABA Agonists
GABA Agents
Neurotransmitter Agents

Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Physiological Effects of Drugs
Muscle Relaxants, Central
Neuromuscular Agents
Peripheral Nervous System Agents
Central Nervous System Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on May 16, 2013

Baclofen for the Treatment of Alcohol Drinkers (BACLOVILLE)