Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12611000355976
Ethics application status
Approved
Date submitted
4/04/2011
Date registered
5/04/2011
Date last updated
5/04/2011
Type of registration
Retrospectively registered

Titles & IDs
Public title
A brief cognitive behavioural intervention for people with methamphetamine use problems
Scientific title
Cognitive behavioural therapy for the reduction of methamphetamine use among people who are regular users of methamphetamines.
Secondary ID [1] 259914 0
Nil
Universal Trial Number (UTN)
U1111-1120-5265
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
methamphetamine use 265521 0
depression 265522 0
Condition category
Condition code
Mental Health 265673 265673 0 0
Addiction
Mental Health 265674 265674 0 0
Depression

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Participants were randomly assigned to either an active treatment (two or four sessions of CBT in addition to a self-help booklet) or control condition (self-help booklet alone). The self-help booklet was developed by the National Drug and Alcohol Research Centre (NDARC, 2001).

Sessions were delivered in person at central research or local health clinics on a once weekly basis. Session 1 occurred immediately following the initial assessment and randomization, with participants returning for a further one or three sessions on a weekly basis depending on whether allocation was to the 2- or 4-session treatment.
Four-session cognitive behaviour therapy condition
A therapist manual (Baker, Lee, Kay-Lambkin, Claire & Jenner, 2003), revised and expanded from that used in the pilot study (Baker et al., 2001) and a self-help booklet (NDARC, 2001) guided treatment sessions, which focused on developing skills to reduce amphetamine use. Sessions were conducted individually and lasted 45-60 minutes. Session content included role-plays and take home exercises for practising skills. The first session involved a motivational interview (Miller & Rollnick, 2002; Miller, Zweben, DiClemente & Rychtarik, 1992) to increase motivation to reduce amphetamine use. The following sessions focused on cognitive-behavioural coping strategies and relapse prevention, using techniques developed by Marlatt and Gordon (1985). The second session focused on identifying high-risk situations for amphetamine use. In the third session, participants were taught how to reduce craving with progressive muscular relaxation and coping self-talk. The fourth session focused on coping with lapses and developing a coping drill to use in high-risk situations following any future lapses.

Two-session cognitive behaviour therapy condition
The procedure and content of the first two sessions was the same as described above for the longer intervention. Participants were also given the same self-help booklet as the intervention group (NDARC, 2001) which details amphetamine related harms and suggestions for reducing amphetamine use.
Intervention code [1] 264337 0
Treatment: Other
Intervention code [2] 264344 0
Behaviour
Comparator / control treatment
Control group
Participants allocated to the control condition were given the same self-help booklet as the intervention conditions (NDARC, 2001).
Control group
Active

Outcomes
Primary outcome [1] 266452 0
Reduction in methamphetamine use relative to baseline, as measured by the Opiate Treatment Index (OTI).
Timepoint [1] 266452 0
5 weeks post-baseline
6 months post-baseline
Primary outcome [2] 266453 0
Reduction In depressive symptoms relative to baseline, as measured by the Beck Depression Inventory II.
Timepoint [2] 266453 0
5 weeks post-baseline
6 months post-baseline
Secondary outcome [1] 273802 0
Improvement in quality of life, as measured by the WHO quality of life scale.
Timepoint [1] 273802 0
5 weeks post-baseline
6 months post-baseline

Eligibility
Key inclusion criteria
Regular methamphetamine use for the month prior to baseline. Regular use of amphetamines was defined as at least weekly use (a score of 0.14 or more for amphetamine use on the Opiate Treatment Index, OTI).
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Exclusion criteria were suicidality or acute psychosis, acquired cognitive impairment and current enrolment in treatment for amphetamine use.

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)
Participants were recruited by means of notices placed within various agencies and treatment centres, media releases and via word of mouth in Newcastle, New South Wales and Brisbane, Queensland, Australia. Notices stated that university researchers were conducting a project to help people regularly using amphetamines to reduce their use. Referral sources included alcohol and other drug services (including needle and syringe programs), word of mouth, media advertisements, general practitioners, a youth service, and other community agencies.

Initial screening of referred potential participants occurred via telephone, and included a brief assessment of current mehtamphetamine use levels and an explanation of the study design. Information sheets and consent forms were posted to all eligible clients, with an appointment made for an in-person assessment for the following week. Participants were assured that all information was strictly confidential to the research team who were independent of any treatment agency and that refusal to participate would not affect their relationship with the agency in any way. Participants were asked to provide written consent to take part in the study and if aged under 18 years, consent was sought from their parent/guardian.

All participants were reimbursed $20 for each assessment interview they completed. Initial interviews took place either in the location from which they were recruited or participants were asked to attend research centres or other local health facilities.

Participants were interviewed for their initial assessment, and then randomly assigned to a study condition.

Interviews took approximately one hour to complete.

The interviewer then undertook the first session if the participant was allocated to a treatment condition, or gave them a self help booklet and made a time for follow-up if allocated to the control condition.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Randomisation was by an independent researcher using random permutations of the numbers 1-4 and 1-8 and a free online randomisation program. The use of two permutation lengths was used to reduce potential for guessing. The randomisation procedure will stratified for gender and pharmacotherapy for heroin dependence. The allocator kept an electronic record of allocations to independently verify correct treatment receipt, and placed written advice of the allocation to the baseline assessor in a sealed and numbered envelope, which the assessor only opened at the conclusion of the initial assessment session.
This procedure ensured that assessment of eligibility and baseline measures are not affected by knowledge of the allocation.
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
31/10/2001
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
214
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
Recruitment postcode(s) [1] 3892 0
2300

Funding & Sponsors
Funding source category [1] 264799 0
Government body
Name [1] 264799 0
Commonwealth Department of Health and Ageing
Country [1] 264799 0
Australia
Primary sponsor type
University
Name
University of Newcastle
Address
University Drive
Callaghan NSW 2308
Country
Australia
Secondary sponsor category [1] 263911 0
University
Name [1] 263911 0
Centre for Drug and Alcohol Studies, University of Queensland
Address [1] 263911 0
The Prince Charles Hospital and Health Service District
270 Roma Street
Brisbane Queensland 4000
Country [1] 263911 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 266773 0
Hunter New England Area Health Human Research Ethics Committee
Ethics committee address [1] 266773 0
Ethics committee country [1] 266773 0
Australia
Date submitted for ethics approval [1] 266773 0
Approval date [1] 266773 0
01/07/2001
Ethics approval number [1] 266773 0
9912153.19

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

Contacts
Principal investigator
Name 32436 0
Address 32436 0
Country 32436 0
Phone 32436 0
Fax 32436 0
Email 32436 0
Contact person for public queries
Name 15683 0
Dr Frances Kay-Lambkin
Address 15683 0
National Drug and Alcohol Research Centre
University of New South Wales
Sydney 2000
Country 15683 0
Australia
Phone 15683 0
+61240335690
Fax 15683 0
+61240335692
Email 15683 0
[email protected]
Contact person for scientific queries
Name 6611 0
Dr Frances Kay-Lambkin
Address 6611 0
National Drug and Alcohol Research Centre
University of New South Wales
Sydney 2000
Country 6611 0
Australia
Phone 6611 0
+61240335690
Fax 6611 0
+61240335692
Email 6611 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.