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

Baclofen as Add-On to Standard Treatment of Alcohol- Dependent Patients and Its Effect on Quality of Life, Clinical and Psychosocial Features: A 12-Week Double-Blind Randomized Controlled Trial

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

Study Overview

• Status: Completed
• Conditions: Alcohol Dependence
• Intervention / Treatment: Drug: Baclofen; Other: Control group

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.

• Study Type: Interventional
• Enrollment (Actual): 75
• Phase: Phase 4

Contacts and Locations

Study Locations

• Israel
  • Hadera, Israel, Mobil Post Hefer 37806
    • Alexander Grinshpoon

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 64 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Single Group Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 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.	Drug: Baclofen; Baclofen 50mg per day for 12 weeks and psychosocial intervention
Other: Psychosocial intervention; Intervention of the addition of placebo to low-intensity psychosocial intervention program. This was the control group	Other: Control group; psychosocial intervention and placebo for 12 weeks; Other Names: Placebo group

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	one year

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	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.	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.	baseline, 6 weeks, 12 weeks, 26 weeks, 52 weeks
Multidimensional Scale of Perceived Social Support	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.	Baseline, 52 weeks
Quality of Life Enjoyment and Satisfaction Questionnaire (Q-LES-Q)	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.	baseline, 6 weeks, 12 weeks, 26 weeks, 52 weeks

Collaborators and Investigators

• Sponsor: Sha'ar Menashe Mental Health Center
• Collaborators: Ministry of Health, Israel
• Investigators: Study Director: Alexander M Ponizovsky, MD, PhD, Ministry of health, State of Israel

Study record dates

Study Major Dates

• Study Start: January 1, 2010
• Primary Completion (Actual): May 1, 2012
• Study Completion (Actual): December 1, 2012

Study Registration Dates

• First Submitted: October 19, 2009
• First Submitted That Met QC Criteria: October 26, 2009
• First Posted (Estimate): October 27, 2009

Study Record Updates

• Last Update Posted (Estimate): January 27, 2017
• Last Update Submitted That Met QC Criteria: November 30, 2016
• Last Verified: November 1, 2016

More Information

Terms related to this study

• Keywords: Alcohol; Baclofen; Baclofen as add-on to standard treatment of alcohol
• Additional Relevant MeSH Terms: Mental Disorders; Chemically-Induced Disorders; Alcohol-Related Disorders; Substance-Related Disorders; Alcoholism; Physiological Effects of Drugs; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; Peripheral Nervous System Agents; GABA Agents; Neuromuscular Agents; Muscle Relaxants, Central; GABA Agonists; GABA-B Receptor Agonists; Baclofen
• Other Study ID Numbers: AGRIN4CTIL

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No