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Trial registered on ANZCTR


Registration number
ACTRN12607000039482
Ethics application status
Approved
Date submitted
2/08/2006
Date registered
12/01/2007
Date last updated
12/01/2007
Type of registration
Retrospectively registered

Titles & IDs
Public title
Novel treatments for alcohol dependence: A randomized controlled trial of structured stepped-care intervention for psychiatric comorbidity
Scientific title
Novel treatments for alcohol dependence: A randomized controlled trial of structured stepped-care intervention for psychiatric comorbidity to improve drinking outcomes and reduce comorbid mood or anxiety symptoms.
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Alcohol Dependence 1533 0
Condition category
Condition code
Mental Health 1629 1629 0 0
Anxiety
Mental Health 1630 1630 0 0
Addiction

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
12-week intervention: Reduction and stabilisation of alcohol intake using pharmacotherapy (naltrexone, acamprosate or a combination of the two)followed by formal psychiatric assessment. Participants meeting criteria for psychiatric comorbidity will be randomised to receive manualised psychological therapy for comorbid psychiatric and alcohol problems.
Intervention code [1] 1264 0
Treatment: Other
Comparator / control treatment
To receive usual counselling care (control group).
Control group
Active

Outcomes
Primary outcome [1] 2247 0
(i) time to relapse (>5 drinks on any one day)
Timepoint [1] 2247 0
Measured at week 12 (post-treatment) and week 26 (follow-up)
Primary outcome [2] 2248 0
(ii) clinician rated severity from Anxiety Disorders Interview Schedule for DSM-IV (ADIS-IV) and Hamilton DepressionRating Scale (HDRS) on anxiety and depressive diagnoses.
Timepoint [2] 2248 0
Measured at week 12 (post-treatment) and week 26 (follow-up)
Secondary outcome [1] 3922 0
(i) time to consumption of any alcohol (lapse) identified by self-reported alcohol consumption.
Timepoint [1] 3922 0
Measured at week 12 (post-treatment) and week 26 (follow-up).
Secondary outcome [2] 3923 0
(ii) self-reported amount of alcohol consumed, expressed as the average consumption per drinking day.
Timepoint [2] 3923 0
Measured at week 12 (post-treatment) and week 26 (follow-up).
Secondary outcome [3] 3924 0
(iii) improvement in depressive or anxiety symptoms (Depression Anxiety and Stress Scale; DASS-21).
Timepoint [3] 3924 0
Measured at week 12 (post-treatment) and week 26 (follow-up).
Secondary outcome [4] 3925 0
(iv) biological markers of alcohol consumption at 6, 12 and 26 weeks (carbohydrate-deficient transferrin (CDT), Liver Function Tests (LFTs) and Mean Cell Volume (MCV)).
Timepoint [4] 3925 0
Measured at week 12 (post-treatment) and week 26 (follow-up).
Secondary outcome [5] 3926 0
(v) episodes of alcohol related harm (psychosocial, occupational, forensic, medical).
Timepoint [5] 3926 0
Measured at week 12 (post-treatment) and week 26 (follow-up).

Eligibility
Key inclusion criteria
Inclusion criteria for step 1: (i) alcohol dependence according to DSM-IV criteria (Diagnostic and Statistical Manual of Mental Disorders 4th edition), with alcohol as the subject’s drug of choice, (ii) adequate cognition and English language skills to give valid consent and complete research interviews (as assessed by the mini mental state examination), (iii) willingness to give written consent, (iv) abstinence from alcohol for between 3 and 21 days (standard clinical criteria for use of acamprosate or naltrexone), (v) resolution of any clinically evident alcohol withdrawal (score 0-1 on RPA hospital alcohol withdrawal scale), and a positive score on the initial comorbidity suspicion checklist (CSC).
Entry criteria to step 2: (i) Completion of 3 weeks on acamprosate and/or natlrexone, (ii) resolution of any clinically evident alcohol withdrawal (score 0-1 on RPA hospital alcohol withdrawal scale), (iii) case formulation and diagnosis for anxiety or depression (see below).
Minimum age
18 Years
Maximum age
65 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Exclusion criteria for step 1: (i) sensitivity to study medications or therapy with these drugs within 6 months, (ii) active major psychiatric disorder associated with significant suicide risk, (iii) pregnancy or lactation, (iv) advanced liver disease (hepatocellular failure, variceal bleeding, ascites or encephalopathy), (v) other serious medical illness that would interfere with adherence to the study protocol.
Exclusion criteria 2: (i) Non-compliance on acamprosate and/or naltrexone, (ii) alcohol consumption at baseline levels, (iii) resolution of clinically evident anxiety or depression as assessed by the case formulation (see below). These patients will be offered further treatment as appropriate within the service and continue to be monitored.

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)
Consecutively numbered sealed envelopes
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Stratfied for concomitant selective serotonin reuptake inhibitor (SSRI) use and randomised by an independent party using shuffled allocation cards
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
subjects will be blind to treatment allocation
Phase
Type of endpoint/s
Efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
1/04/2006
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
60
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)

Funding & Sponsors
Funding source category [1] 1776 0
Government body
Name [1] 1776 0
Alcohol Education and Rehabilitation Fund
Country [1] 1776 0
Australia
Primary sponsor type
University
Name
University of Sydney
Address
Country
Australia
Secondary sponsor category [1] 1581 0
Hospital
Name [1] 1581 0
Royal Prince Alfred Hospital
Address [1] 1581 0
Country [1] 1581 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 3330 0
University of Sydney
Ethics committee address [1] 3330 0
Ethics committee country [1] 3330 0
Australia
Date submitted for ethics approval [1] 3330 0
Approval date [1] 3330 0
19/07/2005
Ethics approval number [1] 3330 0
07-2005/3/8420
Ethics committee name [2] 3331 0
Royal Prince Alfred Hospital
Ethics committee address [2] 3331 0
Ethics committee country [2] 3331 0
Australia
Date submitted for ethics approval [2] 3331 0
Approval date [2] 3331 0
30/03/2006
Ethics approval number [2] 3331 0
X05-0279
Ethics committee name [3] 3332 0
University of NSW
Ethics committee address [3] 3332 0
Ethics committee country [3] 3332 0
Australia
Date submitted for ethics approval [3] 3332 0
Approval date [3] 3332 0
20/06/2006
Ethics approval number [3] 3332 0
HREC06140

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 35171 0
Address 35171 0
Country 35171 0
Phone 35171 0
Fax 35171 0
Email 35171 0
Contact person for public queries
Name 10453 0
Paul Haber
Address 10453 0
Drug Health Services
Royal Prince Alfred Hospital
Missenden Road
Camperdown NSW 2050
Country 10453 0
Australia
Phone 10453 0
+61 2 95156419
Fax 10453 0
+61 2 95158970
Email 10453 0
[email protected]
Contact person for scientific queries
Name 1381 0
Paul Haber
Address 1381 0
Drug Health Services
Royal Prince Alfred Hospital
Missenden Road
Camperdown NSW 2050
Country 1381 0
Australia
Phone 1381 0
+61 2 95156419
Fax 1381 0
+61 2 95158970
Email 1381 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
No additional documents have been identified.