ANZCTR - Registration

Please note the ANZCTR will be unattended from Friday 20 December 2024 for the holidays. The Registry will re-open on Tuesday 7 January 2025. Submissions and updates will not be processed during that time.

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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]

None

Universal Trial Number (UTN)

Trial acronym

Linked study record

Health condition

Health condition(s) or problem(s) studied:

Ecstasy and other Substance Use

Condition category

Condition code

Public Health

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]

Treatment: Other

Intervention code [2]

Behaviour

Intervention code [3]

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]

The primary outcome will be ecstasy use. This is measured by conducting a Timeline Followback interview

Timepoint [1]

1, 4 and 6 month follow up interviews

Secondary outcome [1]

Client satisfaction of E Check Up discussion, measured by administering the Client Satisfaction Questionnaire (CSQ-8)

Timepoint [1]

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]

Government body

Name [1]

Department of Health and Ageing

Address [1]

GPO Box 9848
Canberra ACT 2601

Country [1]

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]

None

Name [1]

Address [1]

Country [1]

Ethics approval

Ethics application status

Approved

Ethics committee name [1]

University of New South Wales Human Research Ethics Committee

Ethics committee address [1]

UNSW Research Services
Rupert Myers Building, Level 3
The University of New South Wales  NSW 2052

Ethics committee country [1]

Australia

Date submitted for ethics approval [1]

20/07/2009

Approval date [1]

25/08/2009

Ethics approval number [1]

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

Address

Country

Phone

Fax

Contact person for public queries

Name

Dr Laila Khawar

Address

National Drug & Alcohol Research Centre
University of New South Wales
Randwick Campus
R1, 22-32 King Street
Randwick NSW 2031

Country

Australia

Phone

+61 2 9385 0352

Fax

+61 2 9385 0201

l.khawar@unsw.edu.au

Contact person for scientific queries

Name

Dr Melissa Norberg

Address

National Drug & Alcohol Research Centre
University of New South Wales
Randwick Campus
R1, 22-32 King Street
Randwick NSW 2031

Country

Australia

Phone

+61 2 9385 0260

Fax

+61 2 9385 0201

m.norberg@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

No additional documents have been identified.

Trial Review

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