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

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

75 participants

Study Classification

INTERVENTIONAL

Study Start Date

2010-01-31

Study Completion Date

2012-12-31

Brief Summary

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

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Detailed Description

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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.

Conditions

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Alcohol Dependence

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Caregivers

Study Groups

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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.

Group Type EXPERIMENTAL

Baclofen

Intervention Type DRUG

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

Group Type OTHER

Control group

Intervention Type OTHER

psychosocial intervention and placebo for 12 weeks

Interventions

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Baclofen

Baclofen 50mg per day for 12 weeks and psychosocial intervention

Intervention Type DRUG

Control group

psychosocial intervention and placebo for 12 weeks

Intervention Type OTHER

Other Intervention Names

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Placebo group

Eligibility Criteria

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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.

Minimum Eligible Age

18 Years

Maximum Eligible Age

64 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No