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

This study has been completed.
Sponsor:
Collaborator:
Ministry of Health, Israel
Information provided by (Responsible Party):
Alexander Grinshpoon, Sha'ar Menashe Mental Health Center
ClinicalTrials.gov Identifier:
NCT01002105
First received: October 19, 2009
Last updated: November 30, 2016
Last verified: November 2016
  Purpose
This is a study of Baclofen as an add-on to standard treatment for alcohol-dependent patients.

Condition Intervention Phase
Alcohol Dependence
Drug: Baclofen
Other: Control group
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Double Blind (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

Resource links provided by NLM:


Further study details as provided by Sha’ar Menashe Mental Health Center:

Primary Outcome Measures:
  • 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.


Secondary Outcome Measures:
  • 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.


Enrollment: 75
Study Start Date: January 2010
Study Completion Date: December 2012
Primary Completion Date: May 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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
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

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.
  Eligibility

Ages Eligible for Study:   18 Years to 64 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01002105

Locations
Israel
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
  More Information

Responsible Party: Alexander Grinshpoon, Dr. Alexander Grinshpoon, Sha'ar Menashe Mental Health Center
ClinicalTrials.gov Identifier: NCT01002105     History of Changes
Other Study ID Numbers: AGRIN4CTIL
Study First Received: October 19, 2009
Results First Received: February 23, 2015
Last Updated: November 30, 2016
Individual Participant Data  
Plan to Share IPD: No

Keywords provided by Sha’ar Menashe Mental Health Center:
Baclofen
Alcohol
Baclofen as add-on to standard treatment of alcohol

Additional relevant MeSH terms:
Alcoholism
Alcohol-Related Disorders
Substance-Related Disorders
Chemically-Induced Disorders
Mental Disorders
Ethanol
Anti-Infective Agents, Local
Anti-Infective Agents
Central Nervous System Depressants
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on April 25, 2017