Alcohol Dependence
Conditions
Keywords
Baclofen, Alcohol, Baclofen as add-on to standard treatment of alcohol
Brief summary
This is a study of Baclofen as an add-on to standard treatment for alcohol-dependent patients.
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.
Interventions
DRUGBaclofen
Baclofen 50mg per day for 12 weeks and psychosocial intervention
OTHERControl group
psychosocial intervention and placebo for 12 weeks
Sponsors
Ministry of Health, Israel
Sha'ar Menashe Mental Health Center
Study design
Allocation
RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Caregiver)
Eligibility
Sex/Gender
ALL
Age
18 Years to 64 Years
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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 |
| 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. |
| 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. |
| 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. |
| 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. |
Countries
Israel
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
Participants by arm
| Arm | Count |
|---|---|
| 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 | 32 |
| Placebo Patients were randomly assigned either to baclofen (N=32) or placebo (N=32) in a double-blind study design | 32 |
| Total | 64 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | condition worsened | 4 | 2 |
| Overall Study | Lost to Follow-up | 10 | 16 |
| Overall Study | non compliance | 5 | 3 |
Baseline characteristics
| Characteristic | Placebo | Total | Baclofen |
|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical Between 18 and 65 years | 32 Participants | 64 Participants | 32 Participants |
| Alcohol intake in last six months | 831 grams 40% alcohol/drinking day STANDARD_DEVIATION 151 | 797.3 grams 40% alcohol/drinking day STANDARD_DEVIATION 150.25 | 763.6 grams 40% alcohol/drinking day STANDARD_DEVIATION 149.5 |
| Gender Female | 8 Participants | 16 Participants | 8 Participants |
| Gender Male | 24 Participants | 48 Participants | 24 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Black or African American | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) White | 32 Participants | 64 Participants | 32 Participants |
| Region of Enrollment Israel | 32 participants | 64 participants | 32 participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 0 / 32 | 0 / 32 |
| serious Total, serious adverse events | 0 / 32 | 0 / 32 |
Outcome results
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.
Time frame: one year
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Baclofen | Percent Abstinent Days | 40 percentage of abstinent days |
| Placebo | Percent Abstinent Days | 36 percentage of abstinent days |
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.
Time frame: baseline, 6 weeks, 12 weeks, 26 weeks, 52 weeks
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Baclofen | General Health Questionnaire | Week 6 (n=21,26) | 15.1 units on a scale | Standard Deviation 5.1 |
| Baclofen | General Health Questionnaire | Week 26 (n=16,17) | 9.9 units on a scale | Standard Deviation 7.1 |
| Baclofen | General Health Questionnaire | Baseline | 17.7 units on a scale | Standard Deviation 5.7 |
| Baclofen | General Health Questionnaire | Week 52 (n=13,12) | 10.1 units on a scale | Standard Deviation 9.2 |
| Baclofen | General Health Questionnaire | Week 12 (n=17,23) | 13.2 units on a scale | Standard Deviation 5.2 |
| Placebo | General Health Questionnaire | Week 52 (n=13,12) | 7.2 units on a scale | Standard Deviation 7.9 |
| Placebo | General Health Questionnaire | Baseline | 18.0 units on a scale | Standard Deviation 6.2 |
| Placebo | General Health Questionnaire | Week 6 (n=21,26) | 14.3 units on a scale | Standard Deviation 5.9 |
| Placebo | General Health Questionnaire | Week 12 (n=17,23) | 15.8 units on a scale | Standard Deviation 7.1 |
| Placebo | General Health Questionnaire | Week 26 (n=16,17) | 9.8 units on a scale | Standard Deviation 12.5 |
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.
Time frame: baseline, 6 weeks, 12 weeks, 26 weeks, 52 weeks
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Baclofen | General Self-Efficacy Scale | Baseline | 25.4 units on a scale | Standard Deviation 6.9 |
| Baclofen | General Self-Efficacy Scale | Week 12 (n=17,23) | 27.8 units on a scale | Standard Deviation 6.9 |
| Baclofen | General Self-Efficacy Scale | Week 26 (n=16,17) | 27.1 units on a scale | Standard Deviation 7.2 |
| Baclofen | General Self-Efficacy Scale | Week 52 (n=13,12) | 25.8 units on a scale | Standard Deviation 5.3 |
| Baclofen | General Self-Efficacy Scale | Week 6 (n=21,26) | 24.1 units on a scale | Standard Deviation 5.8 |
| Placebo | General Self-Efficacy Scale | Week 52 (n=13,12) | 26.5 units on a scale | Standard Deviation 6 |
| Placebo | General Self-Efficacy Scale | Baseline | 23.6 units on a scale | Standard Deviation 8.3 |
| Placebo | General Self-Efficacy Scale | Week 6 (n=21,26) | 23.6 units on a scale | Standard Deviation 6.6 |
| Placebo | General Self-Efficacy Scale | Week 26 (n=16,17) | 27.4 units on a scale | Standard Deviation 6.9 |
| Placebo | General Self-Efficacy Scale | Week 12 (n=17,23) | 25.6 units on a scale | Standard Deviation 6 |
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.
Time frame: Baseline, 52 weeks
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Baclofen | Multidimensional Scale of Perceived Social Support | Total at Baseline | 55.1 units on a scale | Standard Deviation 18.3 |
| Baclofen | Multidimensional Scale of Perceived Social Support | Family at Baseline | 19.4 units on a scale | Standard Deviation 5.9 |
| Baclofen | Multidimensional Scale of Perceived Social Support | Friends at Baseline | 15.6 units on a scale | Standard Deviation 8.3 |
| Baclofen | Multidimensional Scale of Perceived Social Support | Others at Baseline | 20.1 units on a scale | Standard Deviation 7 |
| Baclofen | Multidimensional Scale of Perceived Social Support | Total at 52 weeks (n=13,12) | 60.9 units on a scale | Standard Deviation 18.7 |
| Baclofen | Multidimensional Scale of Perceived Social Support | Family at 52 weeks (n=13,12) | 20.6 units on a scale | Standard Deviation 6.3 |
| Baclofen | Multidimensional Scale of Perceived Social Support | Friends at 52 weeks (n=13,12) | 18.3 units on a scale | Standard Deviation 7.6 |
| Baclofen | Multidimensional Scale of Perceived Social Support | Others at 52 weeks (n=13,12) | 20.8 units on a scale | Standard Deviation 6.3 |
| Placebo | Multidimensional Scale of Perceived Social Support | Others at 52 weeks (n=13,12) | 19.2 units on a scale | Standard Deviation 7 |
| Placebo | Multidimensional Scale of Perceived Social Support | Total at Baseline | 55.2 units on a scale | Standard Deviation 14.8 |
| Placebo | Multidimensional Scale of Perceived Social Support | Total at 52 weeks (n=13,12) | 55.9 units on a scale | Standard Deviation 18.1 |
| Placebo | Multidimensional Scale of Perceived Social Support | Family at Baseline | 18.2 units on a scale | Standard Deviation 6.7 |
| Placebo | Multidimensional Scale of Perceived Social Support | Friends at 52 weeks (n=13,12) | 18.2 units on a scale | Standard Deviation 5.5 |
| Placebo | Multidimensional Scale of Perceived Social Support | Friends at Baseline | 16.8 units on a scale | Standard Deviation 6.6 |
| Placebo | Multidimensional Scale of Perceived Social Support | Family at 52 weeks (n=13,12) | 18.3 units on a scale | Standard Deviation 6.8 |
| Placebo | Multidimensional Scale of Perceived Social Support | Others at Baseline | 20.3 units on a scale | Standard Deviation 5.7 |
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
Time frame: baseline, 6 weeks, 12 weeks, 26 weeks, 52 weeks
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Baclofen | Obsessive-Compulsive Drinking Scale Scores | OCDS at Baseline | 28.7 units on a scale | Standard Deviation 9.8 |
| Baclofen | Obsessive-Compulsive Drinking Scale Scores | OD at Baseline | 11.4 units on a scale | Standard Deviation 4.8 |
| Baclofen | Obsessive-Compulsive Drinking Scale Scores | CD at Baseline | 17.3 units on a scale | Standard Deviation 6.8 |
| Baclofen | Obsessive-Compulsive Drinking Scale Scores | OCDS at 6 weeks (n=21,26) | 17.4 units on a scale | Standard Deviation 9.2 |
| Baclofen | Obsessive-Compulsive Drinking Scale Scores | OD at 6 weeks (n=21,26) | 6.9 units on a scale | Standard Deviation 4.3 |
| Baclofen | Obsessive-Compulsive Drinking Scale Scores | OCDS at 12 weeks (n=17,23) | 11.5 units on a scale | Standard Deviation 9.3 |
| Baclofen | Obsessive-Compulsive Drinking Scale Scores | OD at 12 weeks (n=17,23) | 4.5 units on a scale | Standard Deviation 3.9 |
| Baclofen | Obsessive-Compulsive Drinking Scale Scores | CD at 12 weeks (n=17,23) | 7.1 units on a scale | Standard Deviation 5.9 |
| Baclofen | Obsessive-Compulsive Drinking Scale Scores | OCDS at 26 weeks (n=16,17) | 11.1 units on a scale | Standard Deviation 10.1 |
| Baclofen | Obsessive-Compulsive Drinking Scale Scores | OD at 26 weeks (n=16,17) | 4.6 units on a scale | Standard Deviation 4.3 |
| Baclofen | Obsessive-Compulsive Drinking Scale Scores | CD at 26 weeks (n=16,17) | 6.5 units on a scale | Standard Deviation 6.6 |
| Baclofen | Obsessive-Compulsive Drinking Scale Scores | OCDS at 52 weeks (n=13,12) | 10.5 units on a scale | Standard Deviation 10.1 |
| Baclofen | Obsessive-Compulsive Drinking Scale Scores | OD at 52 weeks (n=13,12) | 4.3 units on a scale | Standard Deviation 4.1 |
| Baclofen | Obsessive-Compulsive Drinking Scale Scores | CD at 52 weeks (n=13,12) | 6.2 units on a scale | Standard Deviation 6.9 |
| Placebo | Obsessive-Compulsive Drinking Scale Scores | CD at 26 weeks (n=16,17) | 4.3 units on a scale | Standard Deviation 5.5 |
| Placebo | Obsessive-Compulsive Drinking Scale Scores | OCDS at Baseline | 28.6 units on a scale | Standard Deviation 12.3 |
| Placebo | Obsessive-Compulsive Drinking Scale Scores | CD at 12 weeks (n=17,23) | 8.3 units on a scale | Standard Deviation 7.2 |
| Placebo | Obsessive-Compulsive Drinking Scale Scores | OD at Baseline | 11.1 units on a scale | Standard Deviation 5.1 |
| Placebo | Obsessive-Compulsive Drinking Scale Scores | OD at 52 weeks (n=13,12) | 3.4 units on a scale | Standard Deviation 3.4 |
| Placebo | Obsessive-Compulsive Drinking Scale Scores | CD at Baseline | 17.6 units on a scale | Standard Deviation 7.7 |
| Placebo | Obsessive-Compulsive Drinking Scale Scores | OCDS at 26 weeks (n=16,17) | 7.9 units on a scale | Standard Deviation 8.6 |
| Placebo | Obsessive-Compulsive Drinking Scale Scores | OCDS at 6 weeks (n=21,26) | 15.1 units on a scale | Standard Deviation 9.4 |
| Placebo | Obsessive-Compulsive Drinking Scale Scores | OCDS at 52 weeks (n=13,12) | 7.8 units on a scale | Standard Deviation 8.7 |
| Placebo | Obsessive-Compulsive Drinking Scale Scores | OD at 6 weeks (n=21,26) | 6.1 units on a scale | Standard Deviation 3.8 |
| Placebo | Obsessive-Compulsive Drinking Scale Scores | OD at 26 weeks (n=16,17) | 3.4 units on a scale | Standard Deviation 3.3 |
| Placebo | Obsessive-Compulsive Drinking Scale Scores | OCDS at 12 weeks (n=17,23) | 12.8 units on a scale | Standard Deviation 11.2 |
| Placebo | Obsessive-Compulsive Drinking Scale Scores | CD at 52 weeks (n=13,12) | 3.6 units on a scale | Standard Deviation 5.4 |
| Placebo | Obsessive-Compulsive Drinking Scale Scores | OD at 12 weeks (n=17,23) | 4.6 units on a scale | Standard Deviation 4.3 |
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.
Time frame: baseline, 6 weeks, 12 weeks, 26 weeks, 52 weeks
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Baclofen | Quality of Life Enjoyment and Satisfaction Questionnaire (Q-LES-Q) | Week 6 (n=21,26) | 3.1 units on a scale | Standard Deviation 0.8 |
| Baclofen | Quality of Life Enjoyment and Satisfaction Questionnaire (Q-LES-Q) | Week 26 (n=16,17) | 3.4 units on a scale | Standard Deviation 0.6 |
| Baclofen | Quality of Life Enjoyment and Satisfaction Questionnaire (Q-LES-Q) | Week 12 (n=17,23) | 3.4 units on a scale | Standard Deviation 0.7 |
| Baclofen | Quality of Life Enjoyment and Satisfaction Questionnaire (Q-LES-Q) | Week 52 (n=13,12) | 3.4 units on a scale | Standard Deviation 0.8 |
| Baclofen | Quality of Life Enjoyment and Satisfaction Questionnaire (Q-LES-Q) | Baseline | 2.8 units on a scale | Standard Deviation 0.8 |
| Placebo | Quality of Life Enjoyment and Satisfaction Questionnaire (Q-LES-Q) | Week 52 (n=13,12) | 3.6 units on a scale | Standard Deviation 0.7 |
| Placebo | Quality of Life Enjoyment and Satisfaction Questionnaire (Q-LES-Q) | Baseline | 2.8 units on a scale | Standard Deviation 1 |
| Placebo | Quality of Life Enjoyment and Satisfaction Questionnaire (Q-LES-Q) | Week 6 (n=21,26) | 3.2 units on a scale | Standard Deviation 0.9 |
| Placebo | Quality of Life Enjoyment and Satisfaction Questionnaire (Q-LES-Q) | Week 12 (n=17,23) | 3.4 units on a scale | Standard Deviation 0.8 |
| Placebo | Quality of Life Enjoyment and Satisfaction Questionnaire (Q-LES-Q) | Week 26 (n=16,17) | 3.6 units on a scale | Standard Deviation 0.9 |