Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12607000273482
Ethics application status
Approved
Date submitted
11/05/2007
Date registered
21/05/2007
Date last updated
19/04/2012
Type of registration
Retrospectively registered

Titles & IDs
Public title
A New Intervention for Alcohol Craving.
Scientific title
A randomised controlled trial of a new intervention incorporating traditional cognitive behavoiur strategies and new craving management strategies to reduce alcohol consumption and craving in a population of alcohol misusers.
Secondary ID [1] 280362 0
Nil
Universal Trial Number (UTN)
Trial acronym
CARM
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Alcohol abuse/dependence 1813 0
Condition category
Condition code
Mental Health 1903 1903 0 0
Addiction

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
This trial aims to investigate the efficacy of a new intervention for alcohol craving. This new intervention incorporates traditional Cognitive Behaviour Therapy (CBT) strategies, as well as new craving reduction and management strategies based on Elaborated Intrusion Theory (Kavanagh, Andrade & May, 2005), such as competing imagery tasks. This new 12-hour craving treatment is delivered over 9 sessions over 11 weeks and is compared against two other evidence-based treatments. One of the comparison treatments is 12 hours of CBT (delivered in 9 sessions over 11 weeks also), incorporating traditional alcohol management strategies such as behavioural scheduling and risk situation planning. The second comparison treatment is a one session 2-hour brief motivational intervention, incorporating Motivational Interviewing, goal setting and basic problem solving for difficult situations.
Intervention code [1] 1750 0
Treatment: Other
Comparator / control treatment
One of the comparison treatments is 12 hours of CBT (delivered in 9 sessions over 11 weeks also), incorporating traditional alcohol management strategies such as behavioural scheduling and risk situation planning. The second comparison treatment is a one session 2-hour brief motivational intervention, incorporating Motivational Interviewing, goal setting and basic problem solving for difficult situations.
Control group
Active

Outcomes
Primary outcome [1] 2708 0
Level of alcohol consumption
Timepoint [1] 2708 0
At baseline and at 3, 6, 9 and 12 months post baseline.
Primary outcome [2] 2709 0
Level of craving
Timepoint [2] 2709 0
At baseline and at 3, 6, 9 and 12 months post baseline.
Secondary outcome [1] 4574 0
The key secondary outcomes being measured include: level of alcohol dependence (Severity of Alcohol Dependence Questionnaire (SADQ-C), Alcohol Use Disorders Identification Test (AUDIT), Problem List); change in diagnosis of alcohol use disorders (Structured Clinical Interview for DSM-IV (SCID)); self-efficacy to control drinking (Controlled Drinking Self-Efficacy Scale (CDSE)); satisfaction with general quality of life (World Health Organisation Quality of Life Scale (WHOQOL)); and changes in craving experience (Alcohol Craving Experience (ACE)).
Timepoint [1] 4574 0
At baseline and at 3, 6, 9 and 12 months post baseline.

Eligibility
Key inclusion criteria
Drinking above National Health and Medical Research Council (NHMRC) recommended limits, meeting diagnostic criteria for alcohol abuse or alcohol dependence and sufficient spoken and written English.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Psychotic disorder, presence of other substance abuse or dependence, injected drug use in preceeding month or currently engaged in other alcohol treatment (psychological or pharmaceutical).

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)
Allocations are sealed in opaque envelopes which are assigned to participants after the assessment, but not opened until the end of the first treatment session.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Allocation sequences were generated using random permutations. Sequences and allocations were generated by a person not connected to the study.
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Blind assessor: The follow-up assessments are conducted by an interviewer who is blind to the treatment allocation.
Phase
Type of endpoint/s
Efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
9/05/2007
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
240
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)

Funding & Sponsors
Funding source category [1] 2049 0
Government body
Name [1] 2049 0
National Health and Medical Research Council
Country [1] 2049 0
Australia
Primary sponsor type
Individual
Name
Professor David J. Kavanagh
Address
Institute of Health and Biomedical Innovation, 60 Musk Ave, Kelvin Grove, QLD, 4059
Country
Australia
Secondary sponsor category [1] 1855 0
Individual
Name [1] 1855 0
Dr Jason P. Connor
Address [1] 1855 0
School of Medicine, K floor, Mental Health Centre, RBWH, Herston, QLD, 4029
Country [1] 1855 0
Australia
Secondary sponsor category [2] 1856 0
Individual
Name [2] 1856 0
A/Prof Thiagarajan Sitharthan
Address [2] 1856 0
Sydney West Area Health Services, 4A Fleet St, North Parramatta, NSW, 2151
Country [2] 1856 0
Australia
Secondary sponsor category [3] 1857 0
Individual
Name [3] 1857 0
Prof Ross Young
Address [3] 1857 0
IHBI, GPO Box 2434, Brisbane QLD 4001
Country [3] 1857 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 3803 0
School of Medicine, The University of Queensland
Ethics committee address [1] 3803 0
Ethics committee country [1] 3803 0
Australia
Date submitted for ethics approval [1] 3803 0
Approval date [1] 3803 0
Ethics approval number [1] 3803 0
2006000986
Ethics committee name [2] 3804 0
Queensland University of Technology
Ethics committee address [2] 3804 0
Ethics committee country [2] 3804 0
Australia
Date submitted for ethics approval [2] 3804 0
Approval date [2] 3804 0
16/01/2008
Ethics approval number [2] 3804 0
0700001047

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

Contacts
Principal investigator
Name 27853 0
Address 27853 0
Country 27853 0
Phone 27853 0
Fax 27853 0
Email 27853 0
Contact person for public queries
Name 10939 0
Jennifer Connolly
Address 10939 0
IHBI, GPO Box 2434, Brisbane QLD 4001
Country 10939 0
Australia
Phone 10939 0
+61 7 31380048
Fax 10939 0
+61 7 31386030
Email 10939 0
jennifer.connolly@qut.edu.au
Contact person for scientific queries
Name 1867 0
Professor David J. Kavanagh
Address 1867 0
IHBI, GPO Box 2434, Brisbane QLD 4001
Country 1867 0
Australia
Phone 1867 0
+61 7 31386143
Fax 1867 0
+61 7 31386030
Email 1867 0
david.kavanagh@qut.edu.au

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.