Trial Review

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been endorsed by the ANZCTR. Before participating in a study, talk to your health care provider and refer to this information for consumers
Trial registered on ANZCTR


Registration number
ACTRN12606000100594
Ethics application status
Approved
Date submitted
13/03/2006
Date registered
15/03/2006
Date last updated
15/03/2006
Type of registration
Prospectively registered

Titles & IDs
Public title
Baclofen for Alcohol Dependence
Scientific title
The safety and efficacy of baclofen for alcohol dependence: a double-blind randomised placebo-controlled trial
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Alcohol Dependence 1064 0
Condition category
Condition code
Mental Health 1144 1144 0 0
Addiction

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
12-week intervention comparing oral baclofen 10mg t.i.d versus oral baclofen 20mg t.i.d. for the treatment of alcohol dependence, and incorporating a manualised behavioural therapy for all participants.
Intervention code [1] 936 0
Treatment: Drugs
Comparator / control treatment
12-week placebo for the treatment of alcohol dependence, and incorporating a manualised behavioural therapy for all participants.
Control group
Placebo

Outcomes
Primary outcome [1] 1538 0
Reduction in the proportion of heavy drinking days across the 12-week treatment period compared to baseline drinking
Timepoint [1] 1538 0
Primary outcome [2] 1539 0
Number and severity of side-effects reported across the 12-week treatment period
Timepoint [2] 1539 0
Primary outcome [3] 1540 0
Reduction in self-reported anxiety and craving
Timepoint [3] 1540 0
At week 12
Secondary outcome [1] 2777 0
Changes in liver function biomarkers (AST, ALT, GGT, bilirubin).
Timepoint [1] 2777 0
At week 4 and week 12.

Eligibility
Key inclusion criteria
DMS-IV criteria for alcohol dependence; Meets criteria for current heavy drinking; Can provide informed written consent; 3-days abstinence prior to treatment; Desires abstinence or to greatly reduce alcohol consumption; Has stable residence and can provide collateral contact details.
Minimum age
18 Years
Maximum age
60 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Clinically significant medical disease that might interfere with the evaluation of the study medication or present a safety concern; Clinically significant psychiatric illness or substance use disorder other than alcohol or nicotine dependence or cannabis abuse; Concurrent use of any psyhotropic medication (except subjects on stable antidepressant doses > 2 months); Concurrent use of anticonvulsants, insulin or oral hypoglycemics, History of complicated alcohol withdrawal; Extremely abnormal LFTs; Women who are pregnant or breadfeeding; Requiring inpatient or more intense outpatient treatment for alcohol dependence; Court-mandated participation in alcohol treatment or impending incarceration.

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)
Participants assigned consecutive identification numbers and given corresponding study medications from sealed packages prepared by a third party, idependent to the research.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Shuffled treatment-group allocation cards in sealed envelopes with identification numbers only.
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Phase 3
Type of endpoint/s
Safety/efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
1/05/2006
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
42
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)

Funding & Sponsors
Funding source category [1] 1249 0
Self funded/Unfunded
Name [1] 1249 0
SSWAHS
Country [1] 1249 0
Australia
Funding source category [2] 1250 0
University
Name [2] 1250 0
Universita Cattolica Del Sacro Cuore
Country [2] 1250 0
Italy
Primary sponsor type
Government body
Name
Sydney South West Area Health Service
Address
Country
Australia
Secondary sponsor category [1] 1104 0
Hospital
Name [1] 1104 0
Royal Prince Alfred Hospital
Address [1] 1104 0
Country [1] 1104 0
Australia
Secondary sponsor category [2] 1105 0
University
Name [2] 1105 0
University of Sydney
Address [2] 1105 0
Country [2] 1105 0
Australia
Secondary sponsor category [3] 1106 0
University
Name [3] 1106 0
National Drug and Alcohol Research Centre
Address [3] 1106 0
Country [3] 1106 0
Australia

Ethics approval
Ethics application status
Approved

Summary
Brief summary
Ethics application submitted and responses to comments are being drafted presently.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 35236 0
Address 35236 0
Country 35236 0
Phone 35236 0
Fax 35236 0
Email 35236 0
Contact person for public queries
Name 10125 0
A/Prof. Paul Haber
Address 10125 0
Drug Health Services
Royal Prince Alfred Hospital
Missenden Road
Camperdown NSW 2050
Country 10125 0
Australia
Phone 10125 0
+61 2 95156419
Fax 10125 0
+61 2 95158970
Email 10125 0
[email protected]
Contact person for scientific queries
Name 1053 0
Associate Professor Paul Haber
Address 1053 0
Drug Health Services
Royal Prince Alfred Hospital
Missenden Road
Camperdown NSW 2050
Country 1053 0
Australia
Phone 1053 0
+61 2 95156419
Fax 1053 0
+61 2 95158970
Email 1053 0
[email protected]

No information has been provided regarding IPD availability


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
SourceTitleYear of PublicationDOI
EmbaseBaclofen for the treatment of alcohol dependence and possible role of comorbid anxiety.2014https://dx.doi.org/10.1093/alcalc/agu062
N.B. These documents automatically identified may not have been verified by the study sponsor.