Baclofen in the Treatment of Alcohol Dependence With or Without Alcoholic Liver Disease

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

104 participants

Study Classification

INTERVENTIONAL

Study Start Date

2013-03-31

Study Completion Date

2017-06-30

Brief Summary

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To explore the effectiveness and biobehavioural basis of baclofen in improving treatment outcomes for alcohol dependence in people with or without alcoholic cirrhosis in a double-blind randomised placebo-controlled trial.

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Detailed Description

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This is a double-blind randomised placebo-controlled study investigating the efficacy of baclofen for the treatment of alcohol dependence in patients with alcoholic liver disease. Medications will be given for 12 weeks, with a further 6 months follow-up. Both male and female participants will be recruited to this study. Trial patients will be randomised to one of three treatment groups: (1) baclofen 30mg/day (10 mg t.i.d), (2) baclofen 75mg/day (25 mg t.i.d) or (3) Placebo (3 matched tabs/day).

This study will also include a second, parallel group of patients with alcohol dependence (non alcoholic-liver disease patients) that will undergo the trial protocol as described above. These patients will be randomised according to a separate list into one of three treatment groups: (1) baclofen 30mg/day (10 mg t.i.d), (2) baclofen 75mg/day (25 mg t.i.d) or (3) Placebo (3 matched tabs/day).

Conditions

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Alcoholic Liver Disease Alcohol Dependence

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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Arm 1

Baclofen low dose

Group Type EXPERIMENTAL

Baclofen 30mg/day

Intervention Type DRUG

30mg/day 10 mg t.i.d

Arm 2

Baclofen high dose

Group Type EXPERIMENTAL

Baclofen 75mg/day

Intervention Type DRUG

75mg/day 25 mg t.i.d

Arm 3

Placebo

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

Placebo 3 matched tabs/day

Interventions

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Baclofen 30mg/day

30mg/day 10 mg t.i.d

Intervention Type DRUG

Baclofen 75mg/day

75mg/day 25 mg t.i.d

Intervention Type DRUG

Placebo

Placebo 3 matched tabs/day

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* ALD (for trial group 1), defined as the presence of symptoms and/or signs referable to liver disease with or without cirrhosis, in which alcohol use is considered to play a major aetiological role. Alcohol use will have exceeded an average of 60g/day in women and 80g/day in men for \>10 years.
* Alcohol dependence according to the ICD-10 criteria (for both trial 1 and 2)
* Adequate cognition and English language skills to give valid consent and complete research interviews
* Willingness to give written informed consent
* Abstinence from alcohol for between 3 and 21 days
* Resolution of any clinically evident alcohol withdrawal (CIWA-AR)

Exclusion Criteria

* Active major psychological disorder associated with psychosis or significant suicide risk
* Pregnancy or lactation
* Concurrent use of any psychotropic medication other than antidepressants
* Substance use other than nicotine if unstable
* Clinical evidence of persisting hepatic encephalopathy
* Pending incarceration
* Lack of stable housing
* Active peptic ulcers
* Unstable diabetes mellitus

Minimum Eligible Age

18 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No