Trial | NCT01711125  Report issue

Title

Baclofen in the Treatment of Alcohol Dependence With or Without Alcoholic Liver Disease
Exploring the Efficacy and Biobehavioural Basis of Baclofen in the Treatment of Alcoholic Liver Disease

  • Phase

    Phase 3

  • Study Type

    Interventional

  • Status

    Completed No Results Posted

  • Intervention/Treatment

    baclofen ...

  • Study Participants

    104
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.
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).
Study Started
Mar 31
2013
Primary Completion
Jun 30
2017
Study Completion
Jun 30
2017
Last Update
Aug 08
2017

Drug Baclofen 30mg/day

30mg/day 10 mg t.i.d

Drug Baclofen 75mg/day

75mg/day 25 mg t.i.d

Drug Placebo

Placebo 3 matched tabs/day

Arm 1 Experimental

Baclofen low dose

Arm 2 Experimental

Baclofen high dose

Arm 3 Placebo Comparator

Placebo

Criteria 

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
No Results Posted