Baclofen as Add-On to Standard Treatment of Alcohol- Dependent Patients

Sha'ar Menashe Mental Health Center75 enrolled

Overview

This is a study of Baclofen as an add-on to standard treatment for alcohol-dependent patients.

Double-blind, placebo-controlled, randomized trial comparing 50 mg/day of baclofen to placebo over 12 weeks, in addition to a low-intensity psychosocial intervention program, with 26-week and 52-week follow-up observations. The percentages of heavy drinking days and abstinent days were the primary outcome measures, and craving; distress and depression levels; self-efficacy; social support from family, friends and significant others; and health-related quality of life (HRQL) were secondary outcomes. Tolerability was also examined.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Enrollment

Conditions

Alcohol Dependence

Interventions

BaclofenDRUG

Baclofen 50mg per day for 12 weeks and psychosocial intervention

Control groupOTHER

psychosocial intervention and placebo for 12 weeks

Eligibility

Sex: ALLMin age: 18 YearsMax age: 64 Years

Medical Language ↔ Plain English

Inclusion Criteria: 1. ICD-10 diagnosis of alcohol dependence (World Health Organization, 1993); 2. Seeking treatment with the aim to stop alcohol consumption; 3. Age ranging from 18 to 60 years; 4. Last alcohol intake reported in the 24 h preceding observation; 5. Presence of a referred family member; 6. Written informed consent provision. Exclusion Criteria:. 1. Serious hepatic, kidney, lung, neurological and cardiovascular, diseases); 2. Suicide risk, acute psychosis, severe depression, organic brain syndromes; 3. Dependence on psychoactive substances other than nicotine.

Locations (1)

Alexander Grinshpoon

Hadera, Israel

Outcomes

Primary Outcomes

Percent Abstinent Days

Percent abstinent days at 52 weeks. % of abstinent days were assessed by (1) patient's self-evaluation; (2) family member interview; (3) calculation of cumulative abstinence duration (CAD), defined as the total number of days of abstinence, Abstinent days was calculated for each Arm as a whole.

Time frame: one year

Secondary Outcomes

Obsessive-Compulsive Drinking Scale Scores

Used to evaluate self-reported alcohol craving. 14 items that provided a total (OCDS) as well as two subscale scores - obsessive drinking (OD) and compulsive drinking (CD). Each of the 14 items are scored from 0 to 4 with the inclusion of 4 split items with only the higher of the two scored items to be used in the total or subscale scores. The OCDS total score ranges from 0-40; the subscales both range from 0 to 20. On all scales, higher scores represent a worse outcome. Data for CD at 6 weeks not available to report

Time frame: baseline, 6 weeks, 12 weeks, 26 weeks, 52 weeks

General Health Questionnaire

The General Health Questionnaire measures whether the respondent has recently experienced a particular symptom or behavior and ranges from 0-much less than usual to 3-much more than usual. Total scores range from 0 to 36 and vary by study population: total scores of about 11-12 are typical, and a score higher than 20 suggests severe problems and psychological distress.

Time frame: baseline, 6 weeks, 12 weeks, 26 weeks, 52 weeks

General Self-Efficacy Scale

The GSES measures one's belief in his/her ability to cope with stressful situations. The scale consists of 10 items (e.g. "Usually I am able to control a situation" or "In unexpected situations, I always know how I must behave myself"). Responses are rated on a 4- point Likert-scale ranging from "absolutely not true" (weighted as 1) to "absolutely true" (weighted as 4), where the higher GSES total scores indicate stronger self-efficacy beliefs.All responses are added to a sum score. The range is from 10 to 40 points with a higher score indicating more self-efficiency.

Data from ClinicalTrials.gov

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