Trial Review

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been endorsed by the ANZCTR. Before participating in a study, talk to your health care provider and refer to this information for consumers
Trial registered on ANZCTR


Registration number
ACTRN12611000180910
Ethics application status
Approved
Date submitted
4/02/2011
Date registered
15/02/2011
Date last updated
15/02/2011
Type of registration
Retrospectively registered

Titles & IDs
Public title
The Ecstasy Check-Up Plus: Development of a brief intervention for ecstasy related problems
Scientific title
The Ecstasy Check-Up Plus: Development of a brief intervention for ecstasy related problems
Secondary ID [1] 253603 0
None
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Ecstasy and other Substance Use 261110 0
Condition category
Condition code
Public Health 259256 259256 0 0
Health promotion/education

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
In the Ecstasy Check Up Plus study sessions, we explore ecstasy use and values, offer feedback regarding use and provide with practical skills for reducing use. 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.

Participants are randomised into either one 50 minute session of motivational interviewing based discussion or three once-weekly 50 minute sessions which are conducted by a trained psychologist. The second and third sessions are based on cognitive behavioural and motivational interviewing discussion. All sessions are conducted face to face at our offices.

The one-session motivational discussion is the same that is being assessed in a similar ANZCTR registered study ( ACTRN12611000136909).
Intervention code [1] 257979 0
Treatment: Other
Intervention code [2] 258025 0
Behaviour
Intervention code [3] 258026 0
Lifestyle
Comparator / control treatment
Participants in the Ecstasy Check Up Plus study will be randomly allocated to either 50 minute session of motivational interviewing based discussion or three once-weekly 50 minute sessions which are conducted by a trained psychologist. All sessions are conducted face to face at our offices.

The first session will we will explore ecstasy use, offer you feedback regarding use and provide with practical skills for reducing your use. It is the participants decision to use the skills or not, and they are not pressured to quit or reduce their ecstasy use. The one session group is considered the control group.
Control group
Active

Outcomes
Primary outcome [1] 262073 0
The primary outcome will be ecstasy use. This is measured by conducting a Timeline Followback interview
Timepoint [1] 262073 0
1, 4 and 6 month follow up interviews
Secondary outcome [1] 273098 0
Client satisfaction of E Check Up discussion, measured by administering the Client Satisfaction Questionnaire (CSQ-8)
Timepoint [1] 273098 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, 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. Allocation of treatment is concealed via sealed opaque envelopes. E Check Up Specialists will complete the baseline assessments to ensure that research assistants remain blind to study condition.
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
24/11/2009
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
300
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)

Funding & Sponsors
Funding source category [1] 258434 0
Government body
Name [1] 258434 0
Department of Health and Ageing
Country [1] 258434 0
Australia
Primary sponsor type
University
Name
University of New South Wales
Address
National Drug & Alcohol Research Centre
University of New South Wales
Randwick Campus
R1, 22-32 King Street
Randwick NSW 2031
Country
Australia
Secondary sponsor category [1] 257582 0
None
Name [1] 257582 0
Address [1] 257582 0
Country [1] 257582 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 260422 0
University of New South Wales Human Research Ethics Committee
Ethics committee address [1] 260422 0
UNSW Research Services
Rupert Myers Building, Level 3
The University of New South Wales NSW 2052
Ethics committee country [1] 260422 0
Australia
Date submitted for ethics approval [1] 260422 0
20/07/2009
Approval date [1] 260422 0
25/08/2009
Ethics approval number [1] 260422 0
99214

Summary
Brief summary
The objective of the proposed research is to evaluate a brief motivational interviewing discussion (Ecstasy Check-Up) for regular ecstasy users (1 session) compared with an extended series of discussions (Ecstasy Check-Up Plus), which involves 1 session of motivational interviewing based discussions plus two session of cognitive behavioural based discussions. Our long-term goal is to decrease ecstasy use in Australia by motivating ecstasy users to reduce their use through providing research based information and discussion.

The primary hypothesis of the proposed study is that the Ecstasy Check-Up Plus will be associated with lower levels of ecstasy use and problems than will the Ecstasy Check-Up. 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 one or three sessions of discussions on their Ecstasy use.

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 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 32177 0
Address 32177 0
Country 32177 0
Phone 32177 0
Fax 32177 0
Email 32177 0
Contact person for public queries
Name 15424 0
Dr Laila Khawar
Address 15424 0
National Drug & Alcohol Research Centre
University of New South Wales
Randwick Campus
R1, 22-32 King Street
Randwick NSW 2031
Country 15424 0
Australia
Phone 15424 0
+61 2 9385 0352
Fax 15424 0
+61 2 9385 0201
Email 15424 0
[email protected]
Contact person for scientific queries
Name 6352 0
Dr Melissa Norberg
Address 6352 0
National Drug & Alcohol Research Centre
University of New South Wales
Randwick Campus
R1, 22-32 King Street
Randwick NSW 2031
Country 6352 0
Australia
Phone 6352 0
+61 2 9385 0260
Fax 6352 0
+61 2 9385 0201
Email 6352 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.