Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12611000136909
Ethics application status
Approved
Date submitted
4/02/2011
Date registered
7/02/2011
Date last updated
4/09/2012
Type of registration
Retrospectively registered

Titles & IDs
Public title
Ecstasy Check-Up: A multi-site trial of a brief intervention for ecstasy use
Scientific title
The Ecstasy Check-up: A multi-site trial of a brief intervention for ecstasy use
Secondary ID [1] 253548 0
NA
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Ecstasy and other substance use 261106 0
Condition category
Condition code
Public Health 259248 259248 0 0
Health promotion/education

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Research Group: Within one 50-minute session, the participant explores his/her ecstasy use and values. The specialist then offers feedback regarding the participant's use and provides participants with practical skills for reducing use. Suggestions are made that are in line with the participant's values. It is the decision of the participant to use these skills or not, and they are not pressured to quit or reduce their ecstasy use.
Intervention code [1] 257976 0
Treatment: Other
Intervention code [2] 257985 0
Lifestyle
Comparator / control treatment
Participants will be randomly allocated either to the Ecstasy Check-Up discussion (Research group) or education-only discussion (Control Group). Participant's in the control group, receive an educational factsheet that contains the latest facts about ecstasy. They will be given up to 15 minutes to discuss the factsheet with the E-check-up specialist. Participant's in the research group receive the educational factsheet, along with feedback from their assessment. Participants in the research group spend 50 minutes discussing their ecstasy use, feedback, and values.
Control group
Active

Outcomes
Primary outcome [1] 262070 0
The primary outcome will be ecstasy use measured by conducting a Timeline Followback interview.
Timepoint [1] 262070 0
Baseline, 1, 4 and 6 month follow up interviews
Secondary outcome [1] 273093 0
Client satisfaction of E Check Up discussion, measured by administering the Client Satisfaction Questionnaire( CSQ-8).
Timepoint [1] 273093 0
1 month Follow up interview

Eligibility
Key inclusion criteria
Have used ecstasy in the past 3 months, aged 16 years and over, fluency in English and willing to provide at least 2 locators
Minimum age
16 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
Have not used Ecstasy in the last 3 months, are aged less than 16 years old and are not literate in English

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)
Recruitment efforts will involve advertisements in the free street press and postings on a range of relevant websites.

Fliers will be distributed to university campuses and music venues. When potential participants initially make contact, they will be screened for eligibility, usually by telephone. Those who are ineligible or do not consent to participate in the study will have their details kept for reporting on the reasons for ineligibility.

When participants appear to meet inclusion criteria, an appointment will be made for a face-to-face discussion about Ecstasy use and values. E Check Up Specialists who complete the baseline assessments are blind to study condition. Sealed opaque envelops, which contain the randomised condition, are not opened until after a participant is deemed eligible for study inclusion.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Software that produces random number sequencing
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
Recruiting
Date of first participant enrolment
Anticipated
30/03/2010
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
175
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)

Funding & Sponsors
Funding source category [1] 258431 0
Government body
Name [1] 258431 0
National Health & Medical Research Council
Country [1] 258431 0
Australia
Primary sponsor type
University
Name
University of New South Wales
Address
National Drug & Alcohol Research Centre
Randwick Campus
R1, 22-32 King Street
Randwick NSW 2031
Country
Australia
Secondary sponsor category [1] 257579 0
University
Name [1] 257579 0
Queensland University of Technology
Address [1] 257579 0
Institute of Health and Biomedical Innovation (IHBI)
60 Musk Avenue
Kelvin Grove Urban Village
Kelvin Grove, Queensland, 4059
Country [1] 257579 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 260416 0
University of New South Wales Human Research Ethics Committee
Ethics committee address [1] 260416 0
UNSW Research Services
Rupert Myers Building, Level 3
The University of New South Wales NSW 2052
Ethics committee country [1] 260416 0
Australia
Date submitted for ethics approval [1] 260416 0
26/11/2009
Approval date [1] 260416 0
17/12/2009
Ethics approval number [1] 260416 0
09377

Summary
Brief summary
Our long-term goal is to decrease ecstasy use in Australia by motivating ecstasy users, through brief and early information and discussion, to reduce their use through providing research based information and discussion. The objective of the proposed research is to evaluate a brief discussion based on motivational interviewing (Ecstasy Check-Up) for regular ecstasy users (1 session) compared with an educational control discussion, which involves provision of an informational booklet regarding the facts and fiction on ecstasy use.

The primary hypothesis of the proposed study is that the one-session brief motivation interviewing discussion will be associated with lower levels of ecstasy use and dependence than the education only discussion. E Check Up sessions in which the specialist more strongly adheres to motivational interviewing principles are expected to have better outcomes.

Additionally, our secondary hypothesis is that participants in the study will like and gain some positive aspects from both conditions, regardless if they have been assigned the research or the education discussion.

The research is of benefit to participants as it offers an opportunity for them to manage their ecstasy use. This lifestyle change has many benefits including improvements in physical and mental health. This benefit, however, cannot be guaranteed; it is dependent on participants’ engagement with the discussion.

At the baseline session, all participants will be assured that any information they provide will remain strictly confidential (within the limits of legal confidentiality and duty of care). After written informed consent is provided and all questions and concerns have been answered, the baseline assessment will occur.

At one-, four-, and six-month follow-ups the research assistant will conduct face-to-face follow-ups with all participants using the measures collected at the baseline assessment. The outcome measures will be modified to assess the relevant durations at each visit. For example, the measures will assess the last 90 days during the baseline assessment, and the past 30-days at the one-month follow-up.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 32173 0
Address 32173 0
Country 32173 0
Phone 32173 0
Fax 32173 0
Email 32173 0
Contact person for public queries
Name 15420 0
Dr Laila Khawar
Address 15420 0
National Drug & Alcohol Research Centre
University of New South Wales
Randwick Campus
R1, 22-32 King Street
Randwick NSW 2031
Country 15420 0
Australia
Phone 15420 0
+61 2 9385 0352
Fax 15420 0
+61 2 9385 0201
Email 15420 0
[email protected]
Contact person for scientific queries
Name 6348 0
Dr Melissa Norberg
Address 6348 0
National Drug & Alcohol Research Centre
University of New South Wales
Randwick Campus
R1, 22-32 King Street
Randwick NSW 2031
Country 6348 0
Australia
Phone 6348 0
+61 2 9385 0260
Fax 6348 0
+61 2 9385 0201
Email 6348 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.