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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/NCT00120601




Registration number
NCT00120601
Ethics application status
Date submitted
11/07/2005
Date registered
18/07/2005
Date last updated
18/07/2005

Titles & IDs
Public title
Trial for the Treatment of Alcohol Dependence
Scientific title
The Role of Pharmacotherapy in Prevention of Relapse in Alcohol Dependence
Secondary ID [1] 0 0
211177
Secondary ID [2] 0 0
X99-0277
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Alcoholism 0 0
Condition category
Condition code
Mental Health 0 0 0 0
Addiction

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - Naltrexone
Treatment: Drugs - Acamprosate

Treatment: Drugs: Naltrexone


Treatment: Drugs: Acamprosate
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Time (days) to relapse
Timepoint [1] 0 0
Primary outcome [2] 0 0
Time (days) to lapse
Timepoint [2] 0 0
Primary outcome [3] 0 0
Days abstinence
Timepoint [3] 0 0
Primary outcome [4] 0 0
Drinks per drinking day
Timepoint [4] 0 0
Primary outcome [5] 0 0
Biochemical measures of liver function
Timepoint [5] 0 0
Secondary outcome [1] 0 0
Craving
Timepoint [1] 0 0
Secondary outcome [2] 0 0
Depression
Timepoint [2] 0 0
Secondary outcome [3] 0 0
Anxiety
Timepoint [3] 0 0
Secondary outcome [4] 0 0
Stress
Timepoint [4] 0 0
Secondary outcome [5] 0 0
Global physical health
Timepoint [5] 0 0
Secondary outcome [6] 0 0
Global mental health
Timepoint [6] 0 0

Eligibility
Key inclusion criteria
- Alcohol dependence according to the ICD10 criteria, with alcohol as the subject's drug
of choice

- Ages 18-65

- Adequate cognition and English language skills to give valid consent and complete
research interviews (as assessed by MMSE)

- Willingness to give written informed consent

- Abstinence from alcohol for between 3 and 21 days, and resolution of any clinically
evident alcohol withdrawal
Minimum age
18 Years
Maximum age
65 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
- Opiate abuse within the last one month

- Sensitivity to study medications or therapy with these drugs within 6 months

- Active major psychiatric disorder associated with psychosis or significant suicide
risk

- Pregnancy or lactation

- Advanced decompensated liver disease (hepatocellular failure, variceal bleeding,
ascites or encephalopathy)

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?



Intervention assignment
Parallel
Other design features
Phase
Phase 4
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Unknown status
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
1/03/2003
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
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
University of Sydney
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
Sydney South West Area Health Service
Address [2] 0 0
Country [2] 0 0
Other collaborator category [3] 0 0
Other
Name [3] 0 0
South Eastern Area Health Service
Address [3] 0 0
Country [3] 0 0
Other collaborator category [4] 0 0
Other
Name [4] 0 0
Wentworth Area Health Services
Address [4] 0 0
Country [4] 0 0

Ethics approval
Ethics application status

Summary
Brief summary
The purpose of this study is to compare the effectiveness of two anti-craving medications,
naltrexone versus acamprosate, in the treatment of alcohol dependence.
Trial website
https://clinicaltrials.gov/ct2/show/NCT00120601
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Paul Haber, MBBAMDFRACP
Address 0 0
Conjoint Associate Professor
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/NCT00120601