None listed
Conditions
Brief summary
Ethics application submitted and responses to comments are being drafted presently.
Interventions
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.
Sponsors
Sydney South West Area Health Service
Study design
Allocation
Randomised controlled trial
Intervention model
Parallel
Primary purpose
Treatment
Masking
Blinded (masking used)
Eligibility
Sex/Gender
All
Age
18 Years to 60 Years
Healthy volunteers
No
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.
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.
Outcome results
None listed