Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12609000148279
Ethics application status
Approved
Date submitted
4/02/2009
Date registered
13/03/2009
Date last updated
20/07/2018
Type of registration
Retrospectively registered

Titles & IDs
Public title
Preventing Relapse: Alcohol Intervention Program for Recovering Drug Users
Scientific title
Preventing Relapse: Alcohol Intervention Program for Recovering Drug Users
Secondary ID [1] 295614 0
Nil known
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Alcohol and drug use 4094 0
Condition category
Condition code
Public Health 4289 4289 0 0
Health service research

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
The intervention to be evaluated in this study (i.e. the alcohol intervention program) is based on an adapted version of the Alcohol Skills Training Program (ASTP), an evidence-based intervention developed for college students in the USA by Professor Alan Marlatt and his colleagues. The Alcohol Intervention Program (AIP) consists of 5, 2-hour group sessions held once weekly for 5 weeks, with a focus on learning controlled drinking techniques in high-risk situations. Total duration of the intervention: 5 weeks. Other components of the program are: learning information regarding alcohol's effects, Blood Alcohol Level (BAL) discrimination training, limit setting, the role of myths about alcohol (outcome expectancies) and social and normative cues for drinking, including mindfulness strategies for counteracting these influences. The program requires facilitation by a qualified therapist and is a closed group program generally consisting of 10 participants. An additional two sessions of Therapeutic Telephone Counselling (TTC) are delivered fortnightly once a person leaves (exits) the Therapeutic Community (TC).
Intervention code [1] 3803 0
Prevention
Comparator / control treatment
The control group consists of 2, 2-hour group sessions, conducted once weekly over 2 weeks. Total duration of the control treatment: 2 weeks. This group will contain similar alcohol education information included in sessions one and two of the intervention group. Information will be that which is commonly known and shared within current drug and alcohol treatment.
Control group
Dose comparison

Outcomes
Primary outcome [1] 5174 0
To reduce alcohol consumption: Addiction Severity Index (ASI; McLellan, Luborsky, Woody & O'Brien, 1980), Alcohol Use Disorders Identification Test (AUDIT; Saunders, Aasland, Babor, de la Fuente, & Grant, 1993), urine screen of 20% random sample.
Timepoint [1] 5174 0
Baseline, 3-month follow-up, and 9-month follow-up
Primary outcome [2] 5175 0
To reduce the risk of relapse to drug use: Timeline Follow-back Method (TLFB; Sobell & Sobell, 1992), urine screen of 20% random sample.
Timepoint [2] 5175 0
Baseline, 3-month follow-up, and 9-month follow-up
Secondary outcome [1] 8714 0
To detect the development of alcohol dependence: Severity of Alcohol Dependence Questionnaire (SADQ-C; Stockwell, Sitharthan, McGrath & Lang, 1994)
Timepoint [1] 8714 0
Baseline, 3-month follow-up, and 9-month follow-up
Secondary outcome [2] 8715 0
To reduce dependence on drugs: Severity of Dependence Scale (SDS; Gossop et al., 1995)
Timepoint [2] 8715 0
Baseline, 3-month follow-up, and 9-month follow-up
Secondary outcome [3] 8716 0
To reduce alcohol-related problems: Short Index of Problems (SIP; Miller, Tonigan & Longabaugh, 1995)
Timepoint [3] 8716 0
Baseline, 3-month follow-up, and 9-month follow-up
Secondary outcome [4] 8717 0
To improve social functioning: Opiate Treatment Index (OTI; Darke, Ward, Hall, Heather, & Wodak, 1991)
Timepoint [4] 8717 0
Baseline, 3-month follow-up, and 9-month follow-up
Secondary outcome [5] 8718 0
To improve wellbeing: Personal Wellbeing Index (PWI; International Wellbeing Group, 2005)
Timepoint [5] 8718 0
Baseline, 3-month follow-up, and 9-month follow-up
Secondary outcome [6] 8786 0
Skill acquisition: Alcohol Expectancies (AE; Leigh & Stacy, 1993), Drinking Refusal Self-Efficacy Questionnaire - Revised (DRSEQ-R; Oei, Hasking, & Young, 2005), Alcohol Knowledge Test (AKT; Staiger & Manning, 2006), Kentucky Inventory of Mindfulness Skills (KIMS; Baer, Smith, & Allen, 2004)
Timepoint [6] 8786 0
Baseline, post-intervention and 9-month follow-up

Eligibility
Key inclusion criteria
(1) Met criteria for current substance dependence, based on Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition (DSM-IV), (2) abstinent for at least 14 days
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
(1) Met criteria for a psychotic disorder, based on Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition (DSM-IV), (2) Met criteria for alcohol dependence, based on Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition (DSM-IV)

Study design
Purpose of the study
Educational / counselling / training
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Approximately 150 (75 in each group) recovering drug users who provided informed consent were recruited for participation in this study from Odyssey House Victoria drug rehabilitation services (inpatient) and Windana Society (drug rehabilitation service in Victoria). Allocation involved contacting the holder of the allocation schedule who was at a central adminstration site within each TC. Participation was voluntary, free of charge and all clients are able to withdraw at any stage. In order to ensure comparability between groups, randomisation occurred after recruitment, selection criteria, and baseline assessments had been conducted approximately 2 weeks into residential treatment. At baseline all eligible participants were assigned a numeric code. An independent researcher (not involved in the study) randomised the participants into the treatment or control groups using computer-based random number generation.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Computer-based random number generation
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
20/08/2006
Actual
23/08/2006
Date of last participant enrolment
Anticipated
Actual
22/05/2008
Date of last data collection
Anticipated
Actual
20/11/2010
Sample size
Target
150
Accrual to date
Final
153
Recruitment in Australia
Recruitment state(s)
VIC
Recruitment postcode(s) [1] 1348 0
3812
Recruitment postcode(s) [2] 1443 0
3093

Funding & Sponsors
Funding source category [1] 4297 0
Charities/Societies/Foundations
Name [1] 4297 0
Alcohol Education and Rehabilitation Fund
Country [1] 4297 0
Australia
Primary sponsor type
University
Name
Deakin University
Address
Deakin University
221 Burwood Highway
Burwood Victoria 3125
Australia
Country
Australia
Secondary sponsor category [1] 3868 0
Other Collaborative groups
Name [1] 3868 0
Odyssey Institute of Studies
Address [1] 3868 0
660 Bridge Road
Richmond
Victoria, 3121
Country [1] 3868 0
Australia
Other collaborator category [1] 513 0
University
Name [1] 513 0
University of Washington
Address [1] 513 0
Professor Alan Marlatt
University of Washington
Department of Psychology
Box 351525
Seattle WA 98195-1525
Country [1] 513 0
United States of America

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 6508 0
Deakin University Human Research Ethics Committee
Ethics committee address [1] 6508 0
Burwood Highway
Burwood VIC 3125
Ethics committee country [1] 6508 0
Australia
Date submitted for ethics approval [1] 6508 0
Approval date [1] 6508 0
31/12/2004
Ethics approval number [1] 6508 0
EC 7-2004

Summary
Brief summary
The primary purpose of the study was to develop, pilot and evaluate a group-based program within a TC, aimed at reducing alcohol problems in drug rehabilitation clients. It was hypothesised that participants who recieved the 5-session intervention would demonstrate reduced alcohol consumption and relapse to drug use, post-residential care. A secondary hypothesis was that participants who received the 5-session intervention would demonstrate improved alcohol use skill acquisition, health status and psychosocial functioning.
Trial website
Trial related presentations / publications
None
Public notes

Contacts
Principal investigator
Name 35016 0
A/Prof Petra Staiger
Address 35016 0
School of Psychology Deakin University 221 Burwood Highway Burwood Victoria 3125 Australia
Country 35016 0
Australia
Phone 35016 0
+61 3 924 46876
Fax 35016 0
+61 3 9244 6858
Email 35016 0
petra.staiger@deakin.edu.au
Contact person for public queries
Name 12363 0
A/Prof Assoc. Prof. Petra Staiger
Address 12363 0
School of Psychology
Deakin University
221 Burwood Highway
Burwood Victoria 3125
Australia
Country 12363 0
Australia
Phone 12363 0
+61 3 924 46876
Fax 12363 0
+61 3 9244 6858
Email 12363 0
petra.staiger@deakin.edu.au
Contact person for scientific queries
Name 3291 0
A/Prof Assoc. Prof. Petra Staiger
Address 3291 0
School of Psychology
Deakin University
221 Burwood Highway
Burwood Victoria 3125
Australia
Country 3291 0
Australia
Phone 3291 0
+61 3 924 46876
Fax 3291 0
+61 3 9244 6858
Email 3291 0
petra.staiger@deakin.edu.au

No information has been provided regarding IPD availability


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No Supporting Document Provided



Results publications and other study-related documents

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