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

Phase 4

Completed

Conditions: Alcohol Dependence

Interventions: Other: Control group
Drug: Baclofen

Registration Number: NCT01002105

Lead Sponsor: Sha'ar Menashe Mental Health Center

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

Detailed Description: 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.

Recruitment & Eligibility

Status: COMPLETED

Sex: All

Target Recruitment: 75

Inclusion Criteria

ICD-10 diagnosis of alcohol dependence (World Health Organization, 1993);
Seeking treatment with the aim to stop alcohol consumption;
Age ranging from 18 to 60 years;
Last alcohol intake reported in the 24 h preceding observation;
Presence of a referred family member;
Written informed consent provision.

Exclusion Criteria

Serious hepatic, kidney, lung, neurological and cardiovascular, diseases);
Suicide risk, acute psychosis, severe depression, organic brain syndromes;
Dependence on psychoactive substances other than nicotine.

Study & Design

Study Type: INTERVENTIONAL

Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Psychosocial intervention	Control group	Intervention of the addition of placebo to low-intensity psychosocial intervention program. This was the control group
Baclofen	Baclofen	The study was a 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.

Primary Outcome Measures

Name	Time	Method
Percent Abstinent Days	one year	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.

Secondary Outcome Measures

Name	Time	Method
Obsessive-Compulsive Drinking Scale Scores	baseline, 6 weeks, 12 weeks, 26 weeks, 52 weeks	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
General Health Questionnaire	baseline, 6 weeks, 12 weeks, 26 weeks, 52 weeks	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.
General Self-Efficacy Scale	baseline, 6 weeks, 12 weeks, 26 weeks, 52 weeks	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.
Multidimensional Scale of Perceived Social Support	Baseline, 52 weeks	The MSPSS is a self-report instrument for assessment of emotional help and the level of satisfaction with the social support obtained from three sources - family, friends and significant others. The scale includes 12 items, each of which refer to the people to whom the respondent would turn if he/she had problems of a personal, health or family nature, as well as financial and employment problems. Responses are scored on a 7-point scale from 1 ('completely disagree') to 7 ('completely agree'). The MSPSS index and three subscales - family, friends and significant others - are computed. MSPSS total score ranged from 12 to 84, with a higher score indicating greater satisfaction with total support. Subscores ranged from 4 to 28, with higher score indicating greater satisfaction.
Quality of Life Enjoyment and Satisfaction Questionnaire (Q-LES-Q)	baseline, 6 weeks, 12 weeks, 26 weeks, 52 weeks	Quality of Life Enjoyment and Satisfaction Questionnaire (Q-LES-Q) is a self-report form composed of 16 items, each rated on a 5-point scale that indicates the degree of enjoyment or satisfaction with: physical health; social relations; ability to function in daily life; ability to get around physically; mood; family relations; sexual drive and interest; ability to work on hobbies, work, leisure time activities; economic status; household activities; and living/housing situation. A total score of 1 to 15 items was computed while item 16 assessing "overall life satisfaction" was not included to avoid exaggerated scores. The total score was averaged from items 1 to 15 and ranged from 1 to 5, with higher scores indicating higher satisfaction.