DrugLib.com — Drug Information Portal

Rx drug information, pharmaceutical research, clinical trials, news, and more



Baclofen for the Treatment of Alcohol Drinkers

Information source: Assistance Publique - Hôpitaux de Paris
ClinicalTrials.gov processed this data on August 20, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Alcoholism

Intervention: Baclofen (Drug); Placebo (Drug)

Phase: Phase 2/Phase 3

Status: Active, not recruiting

Sponsored by: Assistance Publique - Hôpitaux de Paris

Official(s) and/or principal investigator(s):
Philippe Jaury, MD, PhD, Principal Investigator, Affiliation: Paris Descartes University

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.

Clinical Details

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

Study design: Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Primary outcome: Proportion of abstainer patients and patients with a low risk consumption

Secondary outcome:

Distribution of Efficience dosage of baclofen

To evaluate the tolerance of baclofen

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

Evolution of patients under treatment

Cumulative quantity of alcohol drunk in the last month

Quality of life during treatment

Evolution of biology

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

Minimum age: 18 Years. Maximum age: 65 Years. Gender(s): Both.

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

Locations and Contacts

Paris Descartes University, Paris 75014, France
Additional Information

Starting date: May 2012
Last updated: April 29, 2015

Page last updated: August 20, 2015

-- advertisement -- The American Red Cross
 
Home | About Us | Contact Us | Site usage policy | Privacy policy

All Rights reserved - Copyright DrugLib.com, 2006-2017