Alcohol Dependence Clinical Trial
— BacALDOfficial title:
Exploring the Efficacy and Biobehavioural Basis of Baclofen in the Treatment of Alcoholic Liver Disease
Verified date | August 2017 |
Source | South West Sydney Local Health District |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 104 |
Est. completion date | June 2017 |
Est. primary completion date | June 2017 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years to 75 Years |
Eligibility |
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 |
Country | Name | City | State |
---|---|---|---|
Australia | Drug Health Services, Royal Prince Alfred Hospital | Sydney | New South Wales |
Lead Sponsor | Collaborator |
---|---|
South West Sydney Local Health District | National Health and Medical Research Council, Australia, University of Sydney |
Australia,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | alcohol consumption | as measured by the number of days abstinent, number of heavy drinking days, time to relapse, time to lapse and number of drinks per drinking day | 12 weeks | |
Secondary | clinical markers of liver injury | 12 weeks | ||
Secondary | incidence of hepatic side effects | 12 weeks | ||
Secondary | craving for alcohol | 12 weeks | ||
Secondary | early termination due to side effects | 12 weeks |
Status | Clinical Trial | Phase | |
---|---|---|---|
Completed |
NCT02901041 -
Interdisciplinary Study of A Novel Anticonvulsant in Alcoholism
|
Phase 3 | |
Completed |
NCT03340051 -
Remote Alcohol Monitoring and Episodic Thinking
|
N/A | |
Not yet recruiting |
NCT06444243 -
Psilocybin-assisted Therapy for Alcohol Use Disorder
|
Phase 2 | |
Completed |
NCT02705898 -
Lifestyle Physical Activity Intervention for Depressed Alcohol Dependent Women
|
N/A | |
Completed |
NCT02486900 -
Neurofeedback & Alcohol Dependence
|
N/A | |
Completed |
NCT02197598 -
Treatment of Patients Suffering of Alcohol Dependence and Impaired Liver Function With Selincro® As-needed Use
|
Phase 4 | |
Completed |
NCT02179749 -
Mifepristone Treatment of Alcohol Use Disorder
|
Phase 2 | |
Recruiting |
NCT02385643 -
The Efficacy of A Smartphone-based Support System to Reinforce Alcohol Abstinence in Treatment-seeking Patients
|
N/A | |
Completed |
NCT01828866 -
Eye Movement Desensitization and Reprocessing (EMDR) in Alcohol Dependent Patients
|
N/A | |
Terminated |
NCT01408641 -
Topiramate for Alcohol Use in Posttraumatic Stress Disorder
|
N/A | |
Active, not recruiting |
NCT01182766 -
New Treatment for Alcohol and Nicotine Dependence
|
Phase 2/Phase 3 | |
Completed |
NCT01342549 -
Treatment Strategy for Alcohol Use Disorders in Veterans With TBI
|
Phase 3 | |
Completed |
NCT02193204 -
Chronic Alcohol, Stress Inflammatory Response and Relapse Risk
|
N/A | |
Completed |
NCT01165541 -
A Study of Quetiapine and Mirtazapine for the Treatment of Alcohol Dependency
|
Phase 2 | |
Completed |
NCT01176591 -
HBPL Study of the Impact of the NK1 Antagonist Aprepitant
|
Phase 2 | |
Completed |
NCT01056484 -
Mindfulness Meditation for Health
|
Phase 2 | |
Completed |
NCT00585780 -
Prazosin to Reduce Stress-Induced Alcohol/Drug Craving and Relapse
|
Phase 1/Phase 2 | |
Completed |
NCT00607620 -
Disseminating Organizational SBI Services at Trauma Centers
|
N/A | |
Completed |
NCT00884884 -
Aripiprazole and Topiramate on Free-Choice Alcohol Use
|
Phase 2/Phase 3 | |
Completed |
NCT00463346 -
Treatment With Acamprosate in Patients With Schizophrenia and Comorbid Alcoholism
|
Phase 3 |