Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12605000184673
Ethics application status
Approved
Date submitted
18/08/2005
Date registered
19/08/2005
Date last updated
27/04/2012
Type of registration
Prospectively registered

Titles & IDs
Public title
Treatment for alcohol related craving: A preliminary efficacy trial.
Scientific title
Efficacy of a craving reduction program to reduce the alcohol intake of people with alcohol abuse or dependence.
Secondary ID [1] 280410 0
Nil
Universal Trial Number (UTN)
Trial acronym
CARM Program
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Alcohol abuse 280 0
Alcohol dependence 281 0
Condition category
Condition code
Mental Health 317 317 0 0
Addiction

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
This project aims to help people who would like to have more control over how much alcohol they drink by improving how they manage feelings of craving for alcohol. An 8-week delay wait group will act as a control for the single treatment condition. The treatment program is based on Elaborated Intrusion Theory, recently published by the project's Chief Investigator. Its primary focus is on craving reduction and management utilising techniques designed to interrupt, prevent and manage the intrusive thoughts/images associated with cravings. The program also utilises other empirically validated techniques such as motivational interviewing, mindfulness meditation, thought distraction, competing tasks/imagery and cogntive behavioural strategies. The treatment program involves 9 hours of individual therapy contact delivered over 6 sessions.
Intervention code [1] 212 0
Treatment: Other
Comparator / control treatment
An 8-week delay wait group will act as a control for the single treatment condition.
Control group
Active

Outcomes
Primary outcome [1] 371 0
Changes in alcohol consumption levels
Timepoint [1] 371 0
Assessed prior to commencement of the program, throughout the duration of the program and two and four months after the program has been completed.
Primary outcome [2] 372 0
Changes in alcohol craving levels
Timepoint [2] 372 0
Assessed prior to commencement of the program, throughout the duration of the program and two and four months after the program has been completed.
Secondary outcome [1] 827 0
Predictors of outcome will be examined as key secondary outcomes. These include baseline level of intake, degree of alcohol dependence, strength of craving during the first week of alcohol control and confidence in controlling alcohol intake and desire.
Timepoint [1] 827 0
These outcomes will be assessed prior to commencement of the program as well as during and immediately after the program.

Eligibility
Key inclusion criteria
Consuming alcohol at levels higher than those recommended by the NHMRC.- currently meeting DSM-IV criteria for alcohol abuse or alcohol dependence. - able to read, write and speak sufficient English to communicate effectively with the therapist and to understand the session content.
Minimum age
18 Years
Maximum age
Not stated
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
History of, or current, psychotic, major depressive or posttraumatic stress disorder.- current misuse of other substances.- other current alcohol treatment.- presence of any medical condition that contraindicates moderation drinking.

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 will be placed in sealed envelopes by a person not connected with the trial.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
The independent allocator will use random permutations of 1-4 and 1-6 (even vs odd) to minimise guessing.
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Phase 2
Type of endpoint/s
Efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
5/09/2005
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
50
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)

Funding & Sponsors
Funding source category [1] 373 0
University
Name [1] 373 0
The University of Queensland
Country [1] 373 0
Australia
Primary sponsor type
Individual
Name
Professor David J. Kavanagh
Address
IHBI, GPO Box 2434, Brisbane QLD 4001
Country
Australia
Secondary sponsor category [1] 299 0
Individual
Name [1] 299 0
Dr Jason Connor
Address [1] 299 0
School of Medicine, K floor, Mental Health Centre, RBWH, Herston, QLD, 4029
Country [1] 299 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 1363 0
The University of Queensland Medical Research Ethics Committee
Ethics committee address [1] 1363 0
Ethics committee country [1] 1363 0
Australia
Date submitted for ethics approval [1] 1363 0
Approval date [1] 1363 0
Ethics approval number [1] 1363 0

Summary
Brief summary
This project aims to help people who would like to have more control over how much alcohol they drink by improving how they manage feelings of craving for alcohol. An 8-week delay wait group will act as a control for the single treatment condition. The treatment program is based on Elaborated Intrusion Theory, recently published by the project's Chief Investigator. Its primary focus is on craving reduction and management utilising techniques designed to interrupt, prevent and manage the intrusive thoughts/images associated with cravings. The program also utilises other empirically validated techniques such as motivational interviewing, mindfulness meditation, thought distraction, competing tasks/imagery and cogntive behavioural strategies. The treatment program involves 9 hours of individual therapy contact delivered over 6 sessions.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 35228 0
Address 35228 0
Country 35228 0
Phone 35228 0
Fax 35228 0
Email 35228 0
Contact person for public queries
Name 9401 0
Ms Jennifer Connolly
Address 9401 0
IHBI, GPO Box 2434, Brisbane QLD 4001
Country 9401 0
Australia
Phone 9401 0
+61 7 31380048
Fax 9401 0
+61 7 31386030
Email 9401 0
[email protected]
Contact person for scientific queries
Name 329 0
Prof David Kavanagh
Address 329 0
IHBI, GPO Box 2434, Brisbane QLD 4001
Country 329 0
Australia
Phone 329 0
+61 7 31386143
Fax 329 0
+61 7 31386030
Email 329 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.