Baclofen as Add-On to Standard Treatment of Alcohol- Dependent Patients
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|ClinicalTrials.gov Identifier: NCT01002105|
Recruitment Status : Completed
First Posted : October 27, 2009
Results First Posted : January 27, 2017
Last Update Posted : January 27, 2017
|Condition or disease||Intervention/treatment||Phase|
|Alcohol Dependence||Drug: Baclofen Other: Control group||Phase 4|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||75 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||Double (Participant, Care Provider)|
|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 :||January 2010|
|Actual Primary Completion Date :||May 2012|
|Actual Study Completion Date :||December 2012|
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 50mg per day for 12 weeks and 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 Name: Placebo group
- Percent Abstinent Days [ Time Frame: 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.
- Obsessive-Compulsive Drinking Scale Scores [ Time Frame: 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
- General Health Questionnaire [ Time Frame: 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.
- General Self-Efficacy Scale [ Time Frame: 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.
- Multidimensional Scale of Perceived Social Support [ Time Frame: 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.
- Quality of Life Enjoyment and Satisfaction Questionnaire (Q-LES-Q) [ Time Frame: 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.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01002105
|Hadera, Israel, Mobil Post Hefer 37806|
|Study Director:||Alexander M Ponizovsky, MD, PhD||Ministry of health, State of Israel|