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| Name | Class |
|---|---|
| Ministry of Health, Israel | OTHER_GOV |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Baclofen | Experimental | 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. |
|
| Psychosocial intervention | Other | Intervention of the addition of placebo to low-intensity psychosocial intervention program. This was the control group |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Baclofen | Drug | Baclofen 50mg per day for 12 weeks and psychosocial intervention |
| |
| 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 |
| 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 |
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Inclusion Criteria:
Exclusion Criteria:.
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| Name | Affiliation | Role |
|---|---|---|
| Alexander M Ponizovsky, MD, PhD | Ministry of health, State of Israel | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Alexander Grinshpoon | Hadera | Mobil Post Hefer 37806 | Israel |
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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
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| ID | Title | Description |
|---|---|---|
| FG000 | 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. Baclofen: Baclofen 50mg per day for 12 weeks |
| FG001 | Placebo | Placebo, identical to baclofen was administered to the placebo group for 12 weeks |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | 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. Baclofen: Baclofen 50mg per day for 12 weeks |
| BG001 |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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. | Posted | Number | percentage of abstinent days | one year |
|
1 year
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 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. Baclofen: Baclofen 50mg per day for 12 weeks |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Prof. Alexander Grinshpoon | Shaar Menashe Mental Health Center | +972-4-6278719 | alexander.grinshpoon@sm.health.gov.il |
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| ID | Term |
|---|---|
| D000437 | Alcoholism |
| ID | Term |
|---|---|
| D019973 | Alcohol-Related Disorders |
| D019966 | Substance-Related Disorders |
| D064419 | Chemically-Induced Disorders |
| D001523 | Mental Disorders |
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| ID | Term |
|---|---|
| D001418 | Baclofen |
| D035061 | Control Groups |
| ID | Term |
|---|---|
| D005680 | gamma-Aminobutyric Acid |
| D000613 | Aminobutyrates |
| D002087 | Butyrates |
| D000144 | Acids, Acyclic |
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| Control group |
| Other |
psychosocial intervention and placebo for 12 weeks |
|
|
| 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 |
| condition worsened |
|
| Placebo |
Patients were randomly assigned either to baclofen (N=32) or placebo (N=32) in a double-blind study design |
| BG002 | Total | Total of all reporting groups |
| Participants |
|
| Gender | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| Alcohol intake in last six months | Mean | Standard Deviation | grams 40% alcohol/drinking day |
|
Patients were randomly assigned either to baclofen (N=32) or placebo (N=32) in a double-blind study design
|
|
| Secondary | 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 | Posted | Mean | Standard Deviation | units on a scale | baseline, 6 weeks, 12 weeks, 26 weeks, 52 weeks |
|
|
|
| Secondary | 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. | Posted | Mean | Standard Deviation | units on a scale | baseline, 6 weeks, 12 weeks, 26 weeks, 52 weeks |
|
|
|
| Secondary | 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. | Posted | Mean | Standard Deviation | units on a scale | baseline, 6 weeks, 12 weeks, 26 weeks, 52 weeks |
|
|
|
| Secondary | 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. | Posted | Mean | Standard Deviation | units on a scale | Baseline, 52 weeks |
|
|
|
| Secondary | 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. | Posted | Mean | Standard Deviation | units on a scale | baseline, 6 weeks, 12 weeks, 26 weeks, 52 weeks |
|
|
|
| 0 |
| 32 |
| 0 |
| 32 |
| EG001 | Placebo | 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. | 0 | 32 | 0 | 32 |
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| D002264 |
| Carboxylic Acids |
| D009930 | Organic Chemicals |
| D015340 | Epidemiologic Research Design |
| D004812 | Epidemiologic Methods |
| D008919 | Investigative Techniques |
| D012107 | Research Design |
| D008722 | Methods |
| CD at Baseline |
|
| OCDS at 6 weeks (n=21,26) |
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| OD at 6 weeks (n=21,26) |
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| OCDS at 12 weeks (n=17,23) |
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| OD at 12 weeks (n=17,23) |
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| CD at 12 weeks (n=17,23) |
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| OCDS at 26 weeks (n=16,17) |
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| OD at 26 weeks (n=16,17) |
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| CD at 26 weeks (n=16,17) |
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| OCDS at 52 weeks (n=13,12) |
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| OD at 52 weeks (n=13,12) |
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| CD at 52 weeks (n=13,12) |
|
| Week 12 (n=17,23) |
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| Week 26 (n=16,17) |
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| Week 52 (n=13,12) |
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| Week 12 (n=17,23) |
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| Week 26 (n=16,17) |
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| Week 52 (n=13,12) |
|
| Friends at Baseline |
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| Others at Baseline |
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| Total at 52 weeks (n=13,12) |
|
| Family at 52 weeks (n=13,12) |
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| Friends at 52 weeks (n=13,12) |
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| Others at 52 weeks (n=13,12) |
|
| Week 12 (n=17,23) |
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| Week 26 (n=16,17) |
|
| Week 52 (n=13,12) |
|