Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12609000856213
Ethics application status
Approved
Date submitted
30/09/2009
Date registered
1/10/2009
Date last updated
9/07/2012
Type of registration
Retrospectively registered

Titles & IDs
Public title
Web-based intervention for cannabis use
Scientific title
Randomised controlled trial of a web-based intervention for cannabis use: Change in consumption among regular users who desire to quit
Secondary ID [1] 280684 0
Nil
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Cannabis Use Disorder 251940 0
Condition category
Condition code
Mental Health 252125 252125 0 0
Addiction

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Participants will be invited to participate in a web-based intervention for cannabis use. The treatment will consist of a 6-module website teaching cognitive behavioural therapy, which involves learning ways of coping with desires to use cannabis, how to recognise and avoid high-risk situations for cannabis use, and how to plan alternative ways of coping with situations in which the participant usually uses cannabis. The study runs for six weeks, with a three-month follow-up. We recommend that the participant completes one module per week, although he or she is free to complete the modules at a faster pace.
Intervention code [1] 241359 0
Behaviour
Comparator / control treatment
The control treatment consists of six modules of web-based education relating to cannabis use. The information in the modules is intended as a placebo, and is unlikely to spur users to quit, e.g., cannabis in the workplace, cannabis and driving. The modules do not contain anything aimed at building the reader’s skills or changing his or her attitude toward using cannabis. We recommend that the participant completes one module per week, although he or she is free to complete the modules at a faster pace.
Control group
Placebo

Outcomes
Primary outcome [1] 253004 0
Change in frequency and quantity of cannabis used following the intervention. This will be assessed by self-report, using a 30-day Timeline Followback, where the participant fills out the number of joints/cones consumed during the previous 30 days on a calendar.
Timepoint [1] 253004 0
Post intevention: 6 weeks; Follow-up: 3 months
Secondary outcome [1] 257776 0
Change in symptoms of cannabis dependence. This will be assessed using two self-report questionnaires.
Timepoint [1] 257776 0
Post intevention: 6 weeks; Follow-up: 3 months
Secondary outcome [2] 257778 0
Change in symptoms of cannabis abuse. The participant will complete a self-report questionnaire addressing problematic cannabis use, e.g., cannabis use leading to dangerous situations, getting in trouble with the law as a result of using cannabis.
Timepoint [2] 257778 0
Post intevention: 6 weeks; Follow-up: 3 months

Eligibility
Key inclusion criteria
18 years or older, desire to quit or reduce cannabis use, used cannabis within the last month
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
Currently in treatment for a substance use disorder, had treatment for cannabis use within the previous 3 months, drinks more than 5 standard drinks per day, mental illness that will significantly interfere with participation in the treatment

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)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Who is / are masked / blinded?



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

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
30/09/2009
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
158
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
Recruitment outside Australia
Country [1] 2162 0
New Zealand
State/province [1] 2162 0

Funding & Sponsors
Funding source category [1] 243820 0
Government body
Name [1] 243820 0
Department of Health and Ageing
Country [1] 243820 0
Australia
Primary sponsor type
Government body
Name
Department of Health and Ageing
Address
GPO Box 9848,
Canberra ACT 2601
Country
Australia
Secondary sponsor category [1] 237170 0
University
Name [1] 237170 0
University of New South Wales (UNSW)
Address [1] 237170 0
UNSW, Kensington NSW, 2052
Country [1] 237170 0
Australia

Ethics approval
Ethics application status
Approved

Summary
Brief summary
The purpose of this study is to test the effectiveness of a new web-based treatment for cannabis use. The research hypothesis predicts that, relative to a placebo control group, individuals who receive the intervention will report greater reductions in their cannabis use, and in symptoms of cannabis abuse and dependence.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 30342 0
Address 30342 0
Country 30342 0
Phone 30342 0
Fax 30342 0
Email 30342 0
Contact person for public queries
Name 13589 0
Sally Rooke
Address 13589 0
22-32 King Street, Randwick NSW, 2031
Country 13589 0
Australia
Phone 13589 0
+612 9385 0450
Fax 13589 0
Email 13589 0
reduceyouruse@med.unsw.edu.au
Contact person for scientific queries
Name 4517 0
Sally Rooke
Address 4517 0
22-32 King Street, Randwick NSW, 2031
Country 4517 0
Australia
Phone 4517 0
+612 9385 0450
Fax 4517 0
Email 4517 0
reduceyouruse@med.unsw.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
SourceTitleYear of PublicationDOI
Dimensions AIEffectiveness of a Self-Guided Web-Based Cannabis Treatment Program: Randomized Controlled Trial2013https://doi.org/10.2196/jmir.2256
N.B. These documents automatically identified may not have been verified by the study sponsor.