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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/ct2/show/NCT01711125




Registration number
NCT01711125
Ethics application status
Date submitted
16/10/2012
Date registered
22/10/2012
Date last updated
8/08/2017

Titles & IDs
Public title
Baclofen in the Treatment of Alcohol Dependence With or Without Alcoholic Liver Disease
Scientific title
Exploring the Efficacy and Biobehavioural Basis of Baclofen in the Treatment of Alcoholic Liver Disease
Secondary ID [1] 0 0
X11-0154
Universal Trial Number (UTN)
Trial acronym
BacALD
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Alcoholic Liver Disease 0 0
Alcohol Dependence 0 0
Condition category
Condition code
Oral and Gastrointestinal 0 0 0 0
Other diseases of the mouth, teeth, oesophagus, digestive system including liver and colon
Cancer 0 0 0 0
Liver
Mental Health 0 0 0 0
Addiction

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - Baclofen 30mg/day
Treatment: Drugs - Baclofen 75mg/day
Treatment: Drugs - Placebo

Experimental: Arm 1 - Baclofen low dose

Experimental: Arm 2 - Baclofen high dose

Placebo Comparator: Arm 3 - Placebo


Treatment: Drugs: Baclofen 30mg/day
30mg/day 10 mg t.i.d

Treatment: Drugs: Baclofen 75mg/day
75mg/day 25 mg t.i.d

Treatment: Drugs: Placebo
Placebo 3 matched tabs/day
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
alcohol consumption
Timepoint [1] 0 0
12 weeks
Secondary outcome [1] 0 0
clinical markers of liver injury
Timepoint [1] 0 0
12 weeks
Secondary outcome [2] 0 0
incidence of hepatic side effects
Timepoint [2] 0 0
12 weeks
Secondary outcome [3] 0 0
craving for alcohol
Timepoint [3] 0 0
12 weeks
Secondary outcome [4] 0 0
early termination due to side effects
Timepoint [4] 0 0
12 weeks

Eligibility
Key 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)
Minimum age
18 Years
Maximum age
75 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key 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

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s
The people administering the treatment/s
The people assessing the outcomes
The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Phase 3
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
1/03/2013
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
1/06/2017
Sample size
Target
Accrual to date
Final
104
Recruitment in Australia
Recruitment state(s)
NSW
Recruitment hospital [1] 0 0
Drug Health Services, Royal Prince Alfred Hospital - Sydney
Recruitment postcode(s) [1] 0 0
2050 - Sydney

Funding & Sponsors
Primary sponsor type
Other
Name
South West Sydney Local Health District
Address
Country
Other collaborator category [1] 0 0
Other
Name [1] 0 0
National Health and Medical Research Council, Australia
Address [1] 0 0
Country [1] 0 0
Other collaborator category [2] 0 0
Other
Name [2] 0 0
University of Sydney
Address [2] 0 0
Country [2] 0 0

Ethics approval
Ethics application status

Summary
Brief summary
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.
Trial website
https://clinicaltrials.gov/ct2/show/NCT01711125
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Paul S Haber, MBBS
Address 0 0
Sydney Local Health District
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/ct2/show/NCT01711125