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

Sha'ar Menashe Mental Health Center

Status and phase: Completed; Phase 4

Conditions: Alcohol Dependence

Treatments: Drug: Baclofen; Other: Control group

Study type: Interventional

Funder types: Other

Identifiers

NCT01002105

AGRIN4CTIL

Details and patient eligibility

About

This is a study of Baclofen as an add-on to standard treatment for alcohol-dependent patients.

Full 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.

Enrollment: 75 patients

Sex: All

Ages: 18 to 64 years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion 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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Single Group Assignment

Masking: Double Blind

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75 participants in 2 patient groups

Baclofen

Experimental group

Description:

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.

Treatment:

Drug: Baclofen

Psychosocial intervention

Other group

Description:

Intervention of the addition of placebo to low-intensity psychosocial intervention program. This was the control group

Treatment:

Other: Control group