Ignite Creation Date:
2025-12-25 @ 3:29 AM
Ignite Modification Date:
2025-12-26 @ 2:10 AM
Study NCT ID:
NCT01002105
Status:
COMPLETED
Last Update Posted:
2017-01-27
First Post:
2009-10-19
Is NOT Gene Therapy:
False
Has Adverse Events:
True
Brief Title:
Baclofen as Add-On to Standard Treatment of Alcohol- Dependent Patients
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D000437', 'term': 'Alcoholism'}], 'ancestors': [{'id': 'D019973', 'term': 'Alcohol-Related Disorders'}, {'id': 'D019966', 'term': 'Substance-Related Disorders'}, {'id': 'D064419', 'term': 'Chemically-Induced Disorders'}, {'id': 'D001523', 'term': 'Mental Disorders'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D001418', 'term': 'Baclofen'}, {'id': 'D035061', 'term': 'Control Groups'}], 'ancestors': [{'id': 'D005680', 'term': 'gamma-Aminobutyric Acid'}, {'id': 'D000613', 'term': 'Aminobutyrates'}, {'id': 'D002087', 'term': 'Butyrates'}, {'id': 'D000144', 'term': 'Acids, Acyclic'}, {'id': 'D002264', 'term': 'Carboxylic Acids'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D015340', 'term': 'Epidemiologic Research Design'}, {'id': 'D004812', 'term': 'Epidemiologic Methods'}, {'id': 'D008919', 'term': 'Investigative Techniques'}, {'id': 'D012107', 'term': 'Research Design'}, {'id': 'D008722', 'term': 'Methods'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'alexander.grinshpoon@sm.health.gov.il', 'phone': '+972-4-6278719', 'title': 'Prof. Alexander Grinshpoon', 'organization': 'Shaar Menashe Mental Health Center'}, 'certainAgreement': {'piSponsorEmployee': False, 'restrictiveAgreement': False}}, 'adverseEventsModule': {'timeFrame': '1 year', 'eventGroups': [{'id': 'EG000', 'title': 'Baclofen', '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.\n\nBaclofen: Baclofen 50mg per day for 12 weeks', 'otherNumAtRisk': 32, 'otherNumAffected': 0, 'seriousNumAtRisk': 32, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'Placebo', 'description': '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.', 'otherNumAtRisk': 32, 'otherNumAffected': 0, 'seriousNumAtRisk': 32, 'seriousNumAffected': 0}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Percent Abstinent Days', 'denoms': [{'units': 'Participants', 'counts': [{'value': '13', 'groupId': 'OG000'}, {'value': '11', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Baclofen', '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.\n\nBaclofen: Baclofen 50mg per day for 12 weeks'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Patients were randomly assigned either to baclofen (N=32) or placebo (N=32) in a double-blind study design'}], 'classes': [{'categories': [{'measurements': [{'value': '40', 'groupId': 'OG000'}, {'value': '36', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'one year', '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.", 'unitOfMeasure': 'percentage of abstinent days', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Obsessive-Compulsive Drinking Scale Scores', 'denoms': [{'units': 'Participants', 'counts': [{'value': '32', 'groupId': 'OG000'}, {'value': '32', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Baclofen', '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'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Patients were randomly assigned either to baclofen (N=32) or placebo (N=32) in a double-blind study design'}], 'classes': [{'title': 'OCDS at Baseline', 'categories': [{'measurements': [{'value': '28.7', 'spread': '9.8', 'groupId': 'OG000'}, {'value': '28.6', 'spread': '12.3', 'groupId': 'OG001'}]}]}, {'title': 'OD at Baseline', 'categories': [{'measurements': [{'value': '11.4', 'spread': '4.8', 'groupId': 'OG000'}, {'value': '11.1', 'spread': '5.1', 'groupId': 'OG001'}]}]}, {'title': 'CD at Baseline', 'categories': [{'measurements': [{'value': '17.3', 'spread': '6.8', 'groupId': 'OG000'}, {'value': '17.6', 'spread': '7.7', 'groupId': 'OG001'}]}]}, {'title': 'OCDS at 6 weeks (n=21,26)', 'categories': [{'measurements': [{'value': '17.4', 'spread': '9.2', 'groupId': 'OG000'}, {'value': '15.1', 'spread': '9.4', 'groupId': 'OG001'}]}]}, {'title': 'OD at 6 weeks (n=21,26)', 'categories': [{'measurements': [{'value': '6.9', 'spread': '4.3', 'groupId': 'OG000'}, {'value': '6.1', 'spread': '3.8', 'groupId': 'OG001'}]}]}, {'title': 'OCDS at 12 weeks (n=17,23)', 'categories': [{'measurements': [{'value': '11.5', 'spread': '9.3', 'groupId': 'OG000'}, {'value': '12.8', 'spread': '11.2', 'groupId': 'OG001'}]}]}, {'title': 'OD at 12 weeks (n=17,23)', 'categories': [{'measurements': [{'value': '4.5', 'spread': '3.9', 'groupId': 'OG000'}, {'value': '4.6', 'spread': '4.3', 'groupId': 'OG001'}]}]}, {'title': 'CD at 12 weeks (n=17,23)', 'categories': [{'measurements': [{'value': '7.1', 'spread': '5.9', 'groupId': 'OG000'}, {'value': '8.3', 'spread': '7.2', 'groupId': 'OG001'}]}]}, {'title': 'OCDS at 26 weeks (n=16,17)', 'categories': [{'measurements': [{'value': '11.1', 'spread': '10.1', 'groupId': 'OG000'}, {'value': '7.9', 'spread': '8.6', 'groupId': 'OG001'}]}]}, {'title': 'OD at 26 weeks (n=16,17)', 'categories': [{'measurements': [{'value': '4.6', 'spread': '4.3', 'groupId': 'OG000'}, {'value': '3.4', 'spread': '3.3', 'groupId': 'OG001'}]}]}, {'title': 'CD at 26 weeks (n=16,17)', 'categories': [{'measurements': [{'value': '6.5', 'spread': '6.6', 'groupId': 'OG000'}, {'value': '4.3', 'spread': '5.5', 'groupId': 'OG001'}]}]}, {'title': 'OCDS at 52 weeks (n=13,12)', 'categories': [{'measurements': [{'value': '10.5', 'spread': '10.1', 'groupId': 'OG000'}, {'value': '7.8', 'spread': '8.7', 'groupId': 'OG001'}]}]}, {'title': 'OD at 52 weeks (n=13,12)', 'categories': [{'measurements': [{'value': '4.3', 'spread': '4.1', 'groupId': 'OG000'}, {'value': '3.4', 'spread': '3.4', 'groupId': 'OG001'}]}]}, {'title': 'CD at 52 weeks (n=13,12)', 'categories': [{'measurements': [{'value': '6.2', 'spread': '6.9', 'groupId': 'OG000'}, {'value': '3.6', 'spread': '5.4', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'baseline, 6 weeks, 12 weeks, 26 weeks, 52 weeks', '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', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'General Health Questionnaire', 'denoms': [{'units': 'Participants', 'counts': [{'value': '32', 'groupId': 'OG000'}, {'value': '32', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Baclofen', '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.\n\nBaclofen: Baclofen 50mg per day for 12 weeks and psychosocial intervention'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Patients were randomly assigned either to baclofen (N=32) or placebo (N=32) in a double-blind study design'}], 'classes': [{'title': 'Baseline', 'categories': [{'measurements': [{'value': '17.7', 'spread': '5.7', 'groupId': 'OG000'}, {'value': '18.0', 'spread': '6.2', 'groupId': 'OG001'}]}]}, {'title': 'Week 6 (n=21,26)', 'categories': [{'measurements': [{'value': '15.1', 'spread': '5.1', 'groupId': 'OG000'}, {'value': '14.3', 'spread': '5.9', 'groupId': 'OG001'}]}]}, {'title': 'Week 12 (n=17,23)', 'categories': [{'measurements': [{'value': '13.2', 'spread': '5.2', 'groupId': 'OG000'}, {'value': '15.8', 'spread': '7.1', 'groupId': 'OG001'}]}]}, {'title': 'Week 26 (n=16,17)', 'categories': [{'measurements': [{'value': '9.9', 'spread': '7.1', 'groupId': 'OG000'}, {'value': '9.8', 'spread': '12.5', 'groupId': 'OG001'}]}]}, {'title': 'Week 52 (n=13,12)', 'categories': [{'measurements': [{'value': '10.1', 'spread': '9.2', 'groupId': 'OG000'}, {'value': '7.2', 'spread': '7.9', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'baseline, 6 weeks, 12 weeks, 26 weeks, 52 weeks', '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.', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'General Self-Efficacy Scale', 'denoms': [{'units': 'Participants', 'counts': [{'value': '32', 'groupId': 'OG000'}, {'value': '32', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Baclofen', '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.\n\nBaclofen: Baclofen 50mg per day for 12 weeks and psychosocial intervention'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Patients were randomly assigned either to baclofen (N=32) or placebo (N=32) in a double-blind study design'}], 'classes': [{'title': 'Baseline', 'categories': [{'measurements': [{'value': '25.4', 'spread': '6.9', 'groupId': 'OG000'}, {'value': '23.6', 'spread': '8.3', 'groupId': 'OG001'}]}]}, {'title': 'Week 6 (n=21,26)', 'categories': [{'measurements': [{'value': '24.1', 'spread': '5.8', 'groupId': 'OG000'}, {'value': '23.6', 'spread': '6.6', 'groupId': 'OG001'}]}]}, {'title': 'Week 12 (n=17,23)', 'categories': [{'measurements': [{'value': '27.8', 'spread': '6.9', 'groupId': 'OG000'}, {'value': '25.6', 'spread': '6.0', 'groupId': 'OG001'}]}]}, {'title': 'Week 26 (n=16,17)', 'categories': [{'measurements': [{'value': '27.1', 'spread': '7.2', 'groupId': 'OG000'}, {'value': '27.4', 'spread': '6.9', 'groupId': 'OG001'}]}]}, {'title': 'Week 52 (n=13,12)', 'categories': [{'measurements': [{'value': '25.8', 'spread': '5.3', 'groupId': 'OG000'}, {'value': '26.5', 'spread': '6.0', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'baseline, 6 weeks, 12 weeks, 26 weeks, 52 weeks', '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.', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Multidimensional Scale of Perceived Social Support', 'denoms': [{'units': 'Participants', 'counts': [{'value': '32', 'groupId': 'OG000'}, {'value': '32', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Baclofen', '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.\n\nBaclofen: Baclofen 50mg per day for 12 weeks and psychosocial intervention'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Patients were randomly assigned either to baclofen (N=32) or placebo (N=32) in a double-blind study design'}], 'classes': [{'title': 'Total at Baseline', 'categories': [{'measurements': [{'value': '55.1', 'spread': '18.3', 'groupId': 'OG000'}, {'value': '55.2', 'spread': '14.8', 'groupId': 'OG001'}]}]}, {'title': 'Family at Baseline', 'categories': [{'measurements': [{'value': '19.4', 'spread': '5.9', 'groupId': 'OG000'}, {'value': '18.2', 'spread': '6.7', 'groupId': 'OG001'}]}]}, {'title': 'Friends at Baseline', 'categories': [{'measurements': [{'value': '15.6', 'spread': '8.3', 'groupId': 'OG000'}, {'value': '16.8', 'spread': '6.6', 'groupId': 'OG001'}]}]}, {'title': 'Others at Baseline', 'categories': [{'measurements': [{'value': '20.1', 'spread': '7.0', 'groupId': 'OG000'}, {'value': '20.3', 'spread': '5.7', 'groupId': 'OG001'}]}]}, {'title': 'Total at 52 weeks (n=13,12)', 'categories': [{'measurements': [{'value': '60.9', 'spread': '18.7', 'groupId': 'OG000'}, {'value': '55.9', 'spread': '18.1', 'groupId': 'OG001'}]}]}, {'title': 'Family at 52 weeks (n=13,12)', 'categories': [{'measurements': [{'value': '20.6', 'spread': '6.3', 'groupId': 'OG000'}, {'value': '18.3', 'spread': '6.8', 'groupId': 'OG001'}]}]}, {'title': 'Friends at 52 weeks (n=13,12)', 'categories': [{'measurements': [{'value': '18.3', 'spread': '7.6', 'groupId': 'OG000'}, {'value': '18.2', 'spread': '5.5', 'groupId': 'OG001'}]}]}, {'title': 'Others at 52 weeks (n=13,12)', 'categories': [{'measurements': [{'value': '20.8', 'spread': '6.3', 'groupId': 'OG000'}, {'value': '19.2', 'spread': '7.0', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline, 52 weeks', '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.", 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Quality of Life Enjoyment and Satisfaction Questionnaire (Q-LES-Q)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '32', 'groupId': 'OG000'}, {'value': '32', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Baclofen', '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.\n\nBaclofen: Baclofen 50mg per day for 12 weeks and psychosocial intervention'}, {'id': 'OG001', 'title': 'Placebo', 'description': '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'}], 'classes': [{'title': 'Baseline', 'categories': [{'measurements': [{'value': '2.8', 'spread': '0.8', 'groupId': 'OG000'}, {'value': '2.8', 'spread': '1.0', 'groupId': 'OG001'}]}]}, {'title': 'Week 6 (n=21,26)', 'categories': [{'measurements': [{'value': '3.1', 'spread': '0.8', 'groupId': 'OG000'}, {'value': '3.2', 'spread': '0.9', 'groupId': 'OG001'}]}]}, {'title': 'Week 12 (n=17,23)', 'categories': [{'measurements': [{'value': '3.4', 'spread': '0.7', 'groupId': 'OG000'}, {'value': '3.4', 'spread': '0.8', 'groupId': 'OG001'}]}]}, {'title': 'Week 26 (n=16,17)', 'categories': [{'measurements': [{'value': '3.4', 'spread': '0.6', 'groupId': 'OG000'}, {'value': '3.6', 'spread': '0.9', 'groupId': 'OG001'}]}]}, {'title': 'Week 52 (n=13,12)', 'categories': [{'measurements': [{'value': '3.4', 'spread': '0.8', 'groupId': 'OG000'}, {'value': '3.6', 'spread': '0.7', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'baseline, 6 weeks, 12 weeks, 26 weeks, 52 weeks', '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.', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Baclofen', '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.\n\nBaclofen: Baclofen 50mg per day for 12 weeks'}, {'id': 'FG001', 'title': 'Placebo', 'description': 'Placebo, identical to baclofen was administered to the placebo group for 12 weeks'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '32'}, {'groupId': 'FG001', 'numSubjects': '32'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '13'}, {'groupId': 'FG001', 'numSubjects': '11'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '19'}, {'groupId': 'FG001', 'numSubjects': '21'}]}], 'dropWithdraws': [{'type': 'Lost to Follow-up', 'reasons': [{'groupId': 'FG000', 'numSubjects': '10'}, {'groupId': 'FG001', 'numSubjects': '16'}]}, {'type': 'non compliance', 'reasons': [{'groupId': 'FG000', 'numSubjects': '5'}, {'groupId': 'FG001', 'numSubjects': '3'}]}, {'type': 'condition worsened', 'reasons': [{'groupId': 'FG000', 'numSubjects': '4'}, {'groupId': 'FG001', 'numSubjects': '2'}]}]}], 'recruitmentDetails': '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'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '32', 'groupId': 'BG000'}, {'value': '32', 'groupId': 'BG001'}, {'value': '64', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'Baclofen', '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.\n\nBaclofen: Baclofen 50mg per day for 12 weeks'}, {'id': 'BG001', 'title': 'Placebo', 'description': 'Patients were randomly assigned either to baclofen (N=32) or placebo (N=32) in a double-blind study design'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Categorical', 'classes': [{'categories': [{'title': '<=18 years', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Between 18 and 65 years', 'measurements': [{'value': '32', 'groupId': 'BG000'}, {'value': '32', 'groupId': 'BG001'}, {'value': '64', 'groupId': 'BG002'}]}, {'title': '>=65 years', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Gender', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '8', 'groupId': 'BG000'}, {'value': '8', 'groupId': 'BG001'}, {'value': '16', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '24', 'groupId': 'BG000'}, {'value': '24', 'groupId': 'BG001'}, {'value': '48', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race (NIH/OMB)', 'classes': [{'categories': [{'title': 'American Indian or Alaska Native', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Asian', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Native Hawaiian or Other Pacific Islander', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Black or African American', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'White', 'measurements': [{'value': '32', 'groupId': 'BG000'}, {'value': '32', 'groupId': 'BG001'}, {'value': '64', 'groupId': 'BG002'}]}, {'title': 'More than one race', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'Israel', 'categories': [{'measurements': [{'value': '32', 'groupId': 'BG000'}, {'value': '32', 'groupId': 'BG001'}, {'value': '64', 'groupId': 'BG002'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}, {'title': 'Alcohol intake in last six months', 'classes': [{'categories': [{'measurements': [{'value': '763.6', 'spread': '149.5', 'groupId': 'BG000'}, {'value': '831', 'spread': '151.0', 'groupId': 'BG001'}, {'value': '797.3', 'spread': '150.25', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'grams 40% alcohol/drinking day', 'dispersionType': 'STANDARD_DEVIATION'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 75}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2010-01'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2016-11', 'completionDateStruct': {'date': '2012-12', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2016-11-30', 'studyFirstSubmitDate': '2009-10-19', 'resultsFirstSubmitDate': '2015-02-23', 'studyFirstSubmitQcDate': '2009-10-26', 'lastUpdatePostDateStruct': {'date': '2017-01-27', 'type': 'ESTIMATED'}, 'resultsFirstSubmitQcDate': '2016-11-30', 'studyFirstPostDateStruct': {'date': '2009-10-27', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2017-01-27', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2012-05', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Percent Abstinent Days', 'timeFrame': 'one year', '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."}], 'secondaryOutcomes': [{'measure': 'Obsessive-Compulsive Drinking Scale Scores', 'timeFrame': 'baseline, 6 weeks, 12 weeks, 26 weeks, 52 weeks', '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'}, {'measure': 'General Health Questionnaire', 'timeFrame': 'baseline, 6 weeks, 12 weeks, 26 weeks, 52 weeks', '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.'}, {'measure': 'General Self-Efficacy Scale', 'timeFrame': 'baseline, 6 weeks, 12 weeks, 26 weeks, 52 weeks', '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.'}, {'measure': 'Multidimensional Scale of Perceived Social Support', 'timeFrame': 'Baseline, 52 weeks', '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."}, {'measure': 'Quality of Life Enjoyment and Satisfaction Questionnaire (Q-LES-Q)', 'timeFrame': 'baseline, 6 weeks, 12 weeks, 26 weeks, 52 weeks', '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.'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['Baclofen', 'Alcohol', 'Baclofen as add-on to standard treatment of alcohol'], 'conditions': ['Alcohol Dependence']}, 'descriptionModule': {'briefSummary': 'This is a study of Baclofen as an add-on to standard treatment for alcohol-dependent patients.', 'detailedDescription': '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.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '64 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. ICD-10 diagnosis of alcohol dependence (World Health Organization, 1993);\n2. Seeking treatment with the aim to stop alcohol consumption;\n3. Age ranging from 18 to 60 years;\n4. Last alcohol intake reported in the 24 h preceding observation;\n5. Presence of a referred family member;\n6. Written informed consent provision.\n\nExclusion Criteria:.\n\n1. Serious hepatic, kidney, lung, neurological and cardiovascular, diseases);\n2. Suicide risk, acute psychosis, severe depression, organic brain syndromes;\n3. Dependence on psychoactive substances other than nicotine.'}, 'identificationModule': {'nctId': 'NCT01002105', 'briefTitle': 'Baclofen as Add-On to Standard Treatment of Alcohol- Dependent Patients', 'organization': {'class': 'OTHER', 'fullName': "Sha'ar Menashe Mental Health Center"}, 'officialTitle': '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', 'orgStudyIdInfo': {'id': 'AGRIN4CTIL'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Baclofen', '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.', 'interventionNames': ['Drug: Baclofen']}, {'type': 'OTHER', 'label': 'Psychosocial intervention', 'description': 'Intervention of the addition of placebo to low-intensity psychosocial intervention program. This was the control group', 'interventionNames': ['Other: Control group']}], 'interventions': [{'name': 'Baclofen', 'type': 'DRUG', 'description': 'Baclofen 50mg per day for 12 weeks and psychosocial intervention', 'armGroupLabels': ['Baclofen']}, {'name': 'Control group', 'type': 'OTHER', 'otherNames': ['Placebo group'], 'description': 'psychosocial intervention and placebo for 12 weeks', 'armGroupLabels': ['Psychosocial intervention']}]}, 'contactsLocationsModule': {'locations': [{'zip': 'Mobil Post Hefer 37806', 'city': 'Hadera', 'country': 'Israel', 'facility': 'Alexander Grinshpoon', 'geoPoint': {'lat': 32.44192, 'lon': 34.9039}}], 'overallOfficials': [{'name': 'Alexander M Ponizovsky, MD, PhD', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Ministry of health, State of Israel'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': "Sha'ar Menashe Mental Health Center", 'class': 'OTHER'}, 'collaborators': [{'name': 'Ministry of Health, Israel', 'class': 'OTHER_GOV'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Dr. Alexander Grinshpoon', 'investigatorFullName': 'Alexander Grinshpoon', 'investigatorAffiliation': "Sha'ar Menashe Mental Health Center"}}}}