Trial · NCT01002105
Baclofen as Add-On to Standard Treatment of Alcohol- Dependent Patients
NCT01002105, Phase 4, Completed, Sha'ar Menashe Mental Health Center; results first posted 2017-01-27
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Baclofen as Add-On to Standard Treatment of Alcohol- Dependent Patients. Trials, record NCT01002105. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT01002105
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Baclofen as Add-On to Standard Treatment of Alcohol- Dependent Patients
- NCT number
- NCT01002105
- Status
- Completed
- Phases
- Phase 4
- Enrollment
- 75 participants, actual
- Lead sponsor
- Sha'ar Menashe Mental Health Center
- Conditions
- Alcohol Dependence
- Interventions
- Baclofen, Control group
- First posted
- 2009-10-27
- Last updated
- 2017-01-27
- Results first posted
- 2017-01-27
Source ClinicalTrials.gov
Registered outcomes6
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | 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 | 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 |
| Secondary | 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. |
| Secondary | 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. |
| Secondary | 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. |
| Secondary | 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. |
Source ClinicalTrials.gov
Outcomes6
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Percent Abstinent Days | one year | percentage of abstinent days | NUMBER | |
| SECONDARY | Obsessive-Compulsive Drinking Scale Scores | baseline, 6 weeks, 12 weeks, 26 weeks, 52 weeks | units on a scale | MEAN | |
| SECONDARY | General Health Questionnaire | baseline, 6 weeks, 12 weeks, 26 weeks, 52 weeks | units on a scale | MEAN | |
| SECONDARY | General Self-Efficacy Scale | baseline, 6 weeks, 12 weeks, 26 weeks, 52 weeks | units on a scale | MEAN | |
| SECONDARY | Multidimensional Scale of Perceived Social Support | Baseline, 52 weeks | units on a scale | MEAN | |
| SECONDARY | Quality of Life Enjoyment and Satisfaction Questionnaire (Q-LES-Q) | baseline, 6 weeks, 12 weeks, 26 weeks, 52 weeks | units on a scale | MEAN |
Source ClinicalTrials.gov
Results by group76
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Percent Abstinent Days | Baclofen | 40 | percentage of abstinent days | ||
| Percent Abstinent Days | Placebo | 36 | percentage of abstinent days | ||
| Obsessive-Compulsive Drinking Scale Scores | Baclofen | OCDS at Baseline | 28.7 | Standard Deviation 9.8 | units on a scale |
| Obsessive-Compulsive Drinking Scale Scores | Placebo | OCDS at Baseline | 28.6 | Standard Deviation 12.3 | units on a scale |
| Obsessive-Compulsive Drinking Scale Scores | Baclofen | OD at Baseline | 11.4 | Standard Deviation 4.8 | units on a scale |
| Obsessive-Compulsive Drinking Scale Scores | Placebo | OD at Baseline | 11.1 | Standard Deviation 5.1 | units on a scale |
| Obsessive-Compulsive Drinking Scale Scores | Baclofen | CD at Baseline | 17.3 | Standard Deviation 6.8 | units on a scale |
| Obsessive-Compulsive Drinking Scale Scores | Placebo | CD at Baseline | 17.6 | Standard Deviation 7.7 | units on a scale |
| Obsessive-Compulsive Drinking Scale Scores | Baclofen | OCDS at 6 weeks (n=21,26) | 17.4 | Standard Deviation 9.2 | units on a scale |
| Obsessive-Compulsive Drinking Scale Scores | Placebo | OCDS at 6 weeks (n=21,26) | 15.1 | Standard Deviation 9.4 | units on a scale |
1 to 10 of 76Source ClinicalTrials.gov
See all 76 results by groupParticipant flow6
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Baclofen | 32 | |
| Overall Study | STARTED | Placebo | 32 | |
| Overall Study | COMPLETED | Baclofen | 13 | |
| Overall Study | COMPLETED | Placebo | 11 | |
| Overall Study | NOT COMPLETED | Baclofen | 19 | |
| Overall Study | NOT COMPLETED | Placebo | 21 |
Source ClinicalTrials.gov
Adverse events0
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
None in this release.
Adverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Baclofen | ||
| Total, all-cause mortality | Placebo | ||
| Total, other adverse events | Baclofen | 0 | 32 |
| Total, other adverse events | Placebo | 0 | 32 |
| Total, serious adverse events | Baclofen | 0 | 32 |
| Total, serious adverse events | Placebo | 0 | 32 |
Source ClinicalTrials.gov
Papers0
The papers the trial lists on ClinicalTrials.gov.
None in this release.
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons1
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison |
|---|
| Baclofen vs Placebo: serious adverse events |
Source Trial comparisons
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT01002105
GET https://conductscience.org/api/trials/v1/NCT01002105/results?page=2