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

Primary Purpose

Alcohol Dependence

Status
Completed
Phase
Phase 4
Locations
Israel
Study Type
Interventional
Intervention
Baclofen
Control group
Sponsored by
Sha'ar Menashe Mental Health Center
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Alcohol Dependence focused on measuring Baclofen, Alcohol, Baclofen as add-on to standard treatment of alcohol

Eligibility Criteria

18 Years - 64 Years (Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Alexander Grinshpoon

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Other

Arm Label

Baclofen

Psychosocial intervention

Arm Description

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.

Intervention of the addition of placebo to low-intensity psychosocial intervention program. This was the control group

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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
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.
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.
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.
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.

Full Information

First Posted
October 19, 2009
Last Updated
November 30, 2016
Sponsor
Sha'ar Menashe Mental Health Center
Collaborators
Ministry of Health, Israel
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1. Study Identification

Unique Protocol Identification Number
NCT01002105
Brief Title
Baclofen as Add-On to Standard Treatment of Alcohol- Dependent Patients
Official Title
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
Study Type
Interventional

2. Study Status

Record Verification Date
November 2016
Overall Recruitment Status
Completed
Study Start Date
January 2010 (undefined)
Primary Completion Date
May 2012 (Actual)
Study Completion Date
December 2012 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Sha'ar Menashe Mental Health Center
Collaborators
Ministry of Health, Israel

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Alcohol Dependence
Keywords
Baclofen, Alcohol, Baclofen as add-on to standard treatment of alcohol

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Single Group Assignment
Masking
ParticipantCare Provider
Allocation
Randomized
Enrollment
75 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Baclofen
Arm Type
Experimental
Arm Description
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.
Arm Title
Psychosocial intervention
Arm Type
Other
Arm Description
Intervention of the addition of placebo to low-intensity psychosocial intervention program. This was the control group
Intervention Type
Drug
Intervention Name(s)
Baclofen
Intervention Description
Baclofen 50mg per day for 12 weeks and psychosocial intervention
Intervention Type
Other
Intervention Name(s)
Control group
Other Intervention Name(s)
Placebo group
Intervention Description
psychosocial intervention and placebo for 12 weeks
Primary Outcome Measure Information:
Title
Percent Abstinent Days
Description
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 Outcome Measure Information:
Title
Obsessive-Compulsive Drinking Scale Scores
Description
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
Title
General Health Questionnaire
Description
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
Title
General Self-Efficacy Scale
Description
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.
Time Frame
baseline, 6 weeks, 12 weeks, 26 weeks, 52 weeks
Title
Multidimensional Scale of Perceived Social Support
Description
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.
Time Frame
Baseline, 52 weeks
Title
Quality of Life Enjoyment and Satisfaction Questionnaire (Q-LES-Q)
Description
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.
Time Frame
baseline, 6 weeks, 12 weeks, 26 weeks, 52 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
64 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Alexander M Ponizovsky, MD, PhD
Organizational Affiliation
Ministry of health, State of Israel
Official's Role
Study Director
Facility Information:
Facility Name
Alexander Grinshpoon
City
Hadera
ZIP/Postal Code
Mobil Post Hefer 37806
Country
Israel

12. IPD Sharing Statement

Plan to Share IPD
No

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

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