Phase 4
Completed N=64
Baclofen as Add-On to Standard Treatment of Alcohol- Dependent Patients
Source: ClinicalTrials.gov NCT01002105 ↗Enrolled (actual)
64
Serious AEs
0.0%
Results posted
Jan 2017
Primary outcomePrimary: Percent Abstinent Days — 40; 36 percentage of abstinent days
Summary
This is a study of Baclofen as an add-on to standard treatment for alcohol-dependent patients.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Percent Abstinent Days |
40; 36 | — |
| SECONDARY Obsessive-Compulsive Drinking Scale Scores |
28.7; 28.6; 11.4; 11.1; 17.3; 17.6 | — |
| SECONDARY General Health Questionnaire |
17.7; 18.0; 15.1; 14.3; 13.2; 15.8 | — |
| SECONDARY General Self-Efficacy Scale |
25.4; 23.6; 24.1; 23.6; 27.8; 25.6 | — |
| SECONDARY Multidimensional Scale of Perceived Social Support |
55.1; 55.2; 19.4; 18.2; 15.6; 16.8 | — |
| SECONDARY Quality of Life Enjoyment and Satisfaction Questionnaire (Q-LES-Q) |
2.8; 2.8; 3.1; 3.2; 3.4; 3.4 | — |
Eligibility Criteria
Inclusion Criteria
- ICD-10 diagnosis of alcohol dependence (World Health Organization, 1993);
- Seeking treatment with the aim to stop alcohol consumption;
- Age ranging from 18 to 60 years;
- Last alcohol intake reported in the 24 h preceding observation;
- Presence of a referred family member;
- Written informed consent provision.
Exclusion Criteria:.
- Serious hepatic, kidney, lung, neurological and cardiovascular, diseases);
- Suicide risk, acute psychosis, severe depression, organic brain syndromes;
- Dependence on psychoactive substances other than nicotine.
Data sourced from ClinicalTrials.gov (NCT01002105). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.