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

• Sponsor: Sha'ar Menashe Mental Health Center (Other)
• Overall Status: Completed
• CT.gov ID: NCT01002105
• Collaborator: Ministry of Health, Israel (Other)
• Enrollment: 75
• Location: 1
• Arms: 2
• Duration (Months): 35
• Patients Per Site Per Month: 2.1

Study Details

Study Description

Brief Summary

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

Condition or Disease	Intervention/Treatment	Phase
Alcohol Dependence	Drug: Baclofen; Other: Control group	Phase 4

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 Design

• Study Type: Interventional
• Actual Enrollment: 75 participants
• Allocation: Randomized
• Intervention Model: Single Group Assignment
• Masking: Double (Participant, Care Provider)
• Primary Purpose: Treatment
• 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 Start Date: Jan 1, 2010
• Actual Primary Completion Date: May 1, 2012
• Actual Study Completion Date: Dec 1, 2012

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures

1. 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

1. 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

2. 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.

3. 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.

4. 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.

5. 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.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 64 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Alexander Grinshpoon	Hadera		Israel	Mobil Post Hefer 37806

Sponsors and Collaborators

• Sha'ar Menashe Mental Health Center
• Ministry of Health, Israel

Investigators

• Study Director: Alexander M Ponizovsky, MD, PhD, Ministry of health, State of Israel

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Alexander Grinshpoon, Dr. Alexander Grinshpoon, Sha'ar Menashe Mental Health Center
• ClinicalTrials.gov Identifier: NCT01002105
• Other Study ID Numbers: AGRIN4CTIL
• First Posted: Oct 27, 2009
• Last Update Posted: Jan 27, 2017
• Last Verified: Nov 1, 2016

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Keywords provided by Alexander Grinshpoon, Dr. Alexander Grinshpoon, Sha'ar Menashe Mental Health Center: Baclofen; Alcohol; Baclofen as add-on to standard treatment of alcohol
• Additional relevant MeSH terms: Alcoholism; Baclofen

Study Results

Participant Flow

Recruitment Details	1/1/2009 - 31 /12/2010, 75 patients recruited from 15 outpatient centers. Of 75, 4 refused and 7 did not meet the inclusion criteria and 64 patients (48 male and 16 female) were randomly assigned either to baclofen (N=32) or placebo (N=32) in a double-bli

Arm/Group Title	Baclofen	Placebo
Arm/Group 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. Baclofen: Baclofen 50mg per day for 12 weeks	Placebo, identical to baclofen was administered to the placebo group for 12 weeks
Period Title: Overall Study
STARTED	32	32
COMPLETED	13	11
NOT COMPLETED	19	21

Baseline Characteristics

Arm/Group Title	Baclofen	Placebo	Total
Arm/Group 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. Baclofen: Baclofen 50mg per day for 12 weeks	Patients were randomly assigned either to baclofen (N=32) or placebo (N=32) in a double-blind study design	Total of all reporting groups
Overall Participants	32	32	64
Age (Count of Participants)
<=18 years	0 0%	0 0%	0 0%
Between 18 and 65 years	32 100%	32 100%	64 100%
>=65 years	0 0%	0 0%	0 0%
Gender (Count of Participants)
Female	8 25%	8 25%	16 25%
Male	24 75%	24 75%	48 75%
Race (NIH/OMB) (Count of Participants)
American Indian or Alaska Native	0 0%	0 0%	0 0%
Asian	0 0%	0 0%	0 0%
Native Hawaiian or Other Pacific Islander	0 0%	0 0%	0 0%
Black or African American	0 0%	0 0%	0 0%
White	32 100%	32 100%	64 100%
More than one race	0 0%	0 0%	0 0%
Unknown or Not Reported	0 0%	0 0%	0 0%
Region of Enrollment (participants) [Number]
Israel	32 100%	32 100%	64 100%
Alcohol intake in last six months (grams 40% alcohol/drinking day) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [grams 40% alcohol/drinking day]	763.6 (149.5)	831 (151.0)	797.3 (150.25)

Outcome Measures

1. Primary Outcome

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

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Baclofen	Placebo
Arm/Group 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. Baclofen: Baclofen 50mg per day for 12 weeks	Patients were randomly assigned either to baclofen (N=32) or placebo (N=32) in a double-blind study design
Measure Participants	13	11
Number [percentage of abstinent days]	40	36

2. Secondary Outcome

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

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Baclofen	Placebo
Arm/Group 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. Baclofen: Baclofen 50mg per day for 12 weeks	Patients were randomly assigned either to baclofen (N=32) or placebo (N=32) in a double-blind study design
Measure Participants	32	32
OCDS at Baseline	28.7 (9.8)	28.6 (12.3)
OD at Baseline	11.4 (4.8)	11.1 (5.1)
CD at Baseline	17.3 (6.8)	17.6 (7.7)
OCDS at 6 weeks (n=21,26)	17.4 (9.2)	15.1 (9.4)
OD at 6 weeks (n=21,26)	6.9 (4.3)	6.1 (3.8)
OCDS at 12 weeks (n=17,23)	11.5 (9.3)	12.8 (11.2)
OD at 12 weeks (n=17,23)	4.5 (3.9)	4.6 (4.3)
CD at 12 weeks (n=17,23)	7.1 (5.9)	8.3 (7.2)
OCDS at 26 weeks (n=16,17)	11.1 (10.1)	7.9 (8.6)
OD at 26 weeks (n=16,17)	4.6 (4.3)	3.4 (3.3)
CD at 26 weeks (n=16,17)	6.5 (6.6)	4.3 (5.5)
OCDS at 52 weeks (n=13,12)	10.5 (10.1)	7.8 (8.7)
OD at 52 weeks (n=13,12)	4.3 (4.1)	3.4 (3.4)
CD at 52 weeks (n=13,12)	6.2 (6.9)	3.6 (5.4)

3. Secondary Outcome

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

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Baclofen	Placebo
Arm/Group 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. Baclofen: Baclofen 50mg per day for 12 weeks and psychosocial intervention	Patients were randomly assigned either to baclofen (N=32) or placebo (N=32) in a double-blind study design
Measure Participants	32	32
Baseline	17.7 (5.7)	18.0 (6.2)
Week 6 (n=21,26)	15.1 (5.1)	14.3 (5.9)
Week 12 (n=17,23)	13.2 (5.2)	15.8 (7.1)
Week 26 (n=16,17)	9.9 (7.1)	9.8 (12.5)
Week 52 (n=13,12)	10.1 (9.2)	7.2 (7.9)

4. Secondary Outcome

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

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Baclofen	Placebo
Arm/Group 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. Baclofen: Baclofen 50mg per day for 12 weeks and psychosocial intervention	Patients were randomly assigned either to baclofen (N=32) or placebo (N=32) in a double-blind study design
Measure Participants	32	32
Baseline	25.4 (6.9)	23.6 (8.3)
Week 6 (n=21,26)	24.1 (5.8)	23.6 (6.6)
Week 12 (n=17,23)	27.8 (6.9)	25.6 (6.0)
Week 26 (n=16,17)	27.1 (7.2)	27.4 (6.9)
Week 52 (n=13,12)	25.8 (5.3)	26.5 (6.0)

5. Secondary Outcome

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

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Baclofen	Placebo
Arm/Group 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. Baclofen: Baclofen 50mg per day for 12 weeks and psychosocial intervention	Patients were randomly assigned either to baclofen (N=32) or placebo (N=32) in a double-blind study design
Measure Participants	32	32
Total at Baseline	55.1 (18.3)	55.2 (14.8)
Family at Baseline	19.4 (5.9)	18.2 (6.7)
Friends at Baseline	15.6 (8.3)	16.8 (6.6)
Others at Baseline	20.1 (7.0)	20.3 (5.7)
Total at 52 weeks (n=13,12)	60.9 (18.7)	55.9 (18.1)
Family at 52 weeks (n=13,12)	20.6 (6.3)	18.3 (6.8)
Friends at 52 weeks (n=13,12)	18.3 (7.6)	18.2 (5.5)
Others at 52 weeks (n=13,12)	20.8 (6.3)	19.2 (7.0)

6. Secondary Outcome

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

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Baclofen	Placebo
Arm/Group 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. Baclofen: Baclofen 50mg per day for 12 weeks and psychosocial intervention	IThe placebo group received a placebo, identical to the baclofen medication for 12 weeks, in addition to a low-intensity psychosocial intervention program, with 26-week and 52-week follow-up observations
Measure Participants	32	32
Baseline	2.8 (0.8)	2.8 (1.0)
Week 6 (n=21,26)	3.1 (0.8)	3.2 (0.9)
Week 12 (n=17,23)	3.4 (0.7)	3.4 (0.8)
Week 26 (n=16,17)	3.4 (0.6)	3.6 (0.9)
Week 52 (n=13,12)	3.4 (0.8)	3.6 (0.7)

Adverse Events

Time Frame	1 year
Arm/Group Title	Baclofen		Placebo
Arm/Group 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. Baclofen: Baclofen 50mg per day for 12 weeks		The placebo group received a placebo, identical to the baclofen medication for 12 weeks, in addition to a low-intensity psychosocial intervention program, with 26-week and 52-week follow-up observations.
All Cause Mortality
	Baclofen		Placebo
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	/ (NaN)		/ (NaN)
Serious Adverse Events
	Baclofen		Placebo
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/32 (0%)		0/32 (0%)
Other (Not Including Serious) Adverse Events
	Baclofen		Placebo
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/32 (0%)		0/32 (0%)

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

Principal Investigators are NOT employed by the organization sponsoring the study.

There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.