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.

Registering a new trial?

To achieve prospective registration, we recommend submitting your trial for registration at the same time as ethics submission.

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

ACTRN12611000125921

Ethics application status

Approved

Date submitted

3/02/2011

Date registered

3/02/2011

Date last updated

8/02/2012

Type of registration

Retrospectively registered

Titles & IDs

Public title

Randomised Controlled Trial of a Novel Cannabis Use Intervention Delivered by Telephone

Scientific title

Randomised Controlled Trial of a Novel Cannabis Use Intervention Delivered by Telephone

Secondary ID [1]

University of New South Wales, Human Research Ethics Committee number: HREC08349

Universal Trial Number (UTN)

U1111-1119-2771

Trial acronym

Linked study record

Health condition

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

Problematic cannabis use

Condition category

Condition code

Public Health

Other public health

Mental Health

Other mental health disorders

Intervention/exposure

Study type

Interventional

Description of intervention(s) / exposure

4 sessions of telephone counselling based on motivational interviewing techniques, cognitive behavioural therapy, models of behaviour change, and relapse prevention theory. Each session goes for approximately one hour and are delivered once a week. In addition participants will be mailed a self-help booklet that supplements the intervention.

Intervention code [1]

Treatment: Other

Intervention code [2]

Behaviour

Comparator / control treatment

Wait list control (no treatment)

Control group

Active

Outcomes

Primary outcome [1]

Clinically meaningful reductions in cannabis use as assessed by a reduction of at least 50% in frequency of days of use and no report of any cannabis related problems as recorded on the Cannabis Problems Questionnaire

Timepoint [1]

One month (directly after the intervention) and at three month follow up (two months post intervention)

Secondary outcome [1]

Improvements in cannabis dependence as measured by the Severity of Cannabis Dependence Scale, quantity used on a typical day as measured utilising the TimeLine Follow Back method, and a measure of 90 day other substance use and two measures of overall functioning (Kessler 10 and the EuroQol-5D)

Timepoint [1]

One month (directly after the intervention) and at three month follow up (two months post intervention)

Eligibility

Key inclusion criteria

Cannabis use in the 30 days prior to baseline interview

Minimum age

18 Years

Maximum age

No limit

Sex

Both males and females

Can healthy volunteers participate?

Yes

Key exclusion criteria

Current or recent attendance in any drug or alcohol treatments

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)

Subjects are enrolled into the trial after an unprompted telephone call to the Cannabis Information and Helpline. Counsellors on the helpline are asked to inform any callers whom they feel would benefit from knowing about the trial. Interested parties leave their telephone number and are called back for inclusion criteria screening. Once successful the participants are randomly allocated into intervention or control group by a software program capable of producing randomised results

Methods used to generate the sequence in which subjects will be randomised (sequence generation)

A software program produced a randomised list

Masking / blinding

Open (masking not used)

Who is / are masked / blinded?

Intervention assignment

Parallel

Other design features

160 individuals completed baseline, and 110 completed both follow up assessments

Phase

Not Applicable

Type of endpoint/s

Efficacy

Statistical methods / analysis

Recruitment

Recruitment status

Completed

Date of first participant enrolment

Anticipated

16/04/2010

Actual

Date of last participant enrolment

Anticipated

Actual

Date of last data collection

Anticipated

Actual

Sample size

Target

160

Accrual to date

Final

Recruitment in Australia

Recruitment state(s)

Funding & Sponsors

Funding source category [1]

Government body

Name [1]

Australian Government Department of Health and Aging

Address [1]

GPO Box 9848,
Canberra ACT 2601, Australia

Country [1]

Australia

Primary sponsor type

Government body

Name

National Cannabis Prevention and Information Centre

Address

National Cannabis Prevention and Information Centre (NCPIC)
PO Box 684
Randwick NSW 2031
Australia

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]

Level 3, Rupert Myers Building
UNSW Kensington Campus
2052 Sydney

Ethics committee country [1]

Date submitted for ethics approval [1]

Approval date [1]

10/03/2009

Ethics approval number [1]

08349

Summary

Brief summary

Aims To evaluate the efficacy of a telephone-based intervention consisting of four-sessions of motivational interviewing (MI) and cognitive behavioural therapy (CBT) designed to assist individuals to reduce their cannabis use and related problems. Design Random allocation to intervention or delayed treatment control with four- and 12-week follow-up assessments. Setting Counsellors from the Cannabis Information and Helpline (CIH), an Australian reactive telephone service, delivered the intervention to callers seeking treatment. Participants A total of 160 participants were recruited by the CIH, with 110 participants completing the final follow-up assessment (69% retention). Measurements Cannabis use, dependence and related problems, and other substance use, were assessed at baseline and follow-up. Findings Intervention participants reported greater reductions in dependence symptoms (p<0.001), and related problems (p<0.001) compared to control participants at both follow-up assessments. Compared to control, intervention participants reported greater confidence to reduce cannabis use (p=0.002), and in turn reported a greater percentage of abstinent days at twelve weeks (p=0.019). Conclusions The remote delivery of brief MI+CBT cannabis use interventions continues to show promise in assisting a wider audience of treatment seekers while achieving comparable treatment outcomes to those of face-to-face interventions in the short term.

Trial website

Trial related presentations / publications

P. Gates, J. Copeland, M. Norberg, E. Digiusto (2010) Randomised Controlled Trial of a Brief Cannabis Intervention Delivered by Telephone, Poster presentation at the Australasian Professional Society on Alcohol and other Drugs, Canberra, Australia (November)

P. Gates, J. Copeland, M. Norberg, E. Digiusto (2010) Randomised Controlled Trial of a Brief Cannabis Intervention Delivered by Telephone, Poster presentation at the “Advances in Public Health and Health Services Research at UNSW”, Sydney, Australia (May)

Public notes

Contacts

Principal investigator

Name

Address

Country

Phone

Fax

Contact person for public queries

Name

Peter Gates

Address

National Cannabis Prevention and Information Centre (NCPIC)
PO Box 684
Randwick NSW 2031
Australia

Country

Australia

Phone

+61 2 93850269

Fax

p.gates@unsw.edu.au

Contact person for scientific queries

Name

Peter Gates

Address

National Cannabis Prevention and Information Centre (NCPIC)
PO Box 684
Randwick NSW 2031
Australia

Country

Australia

Phone

0293850269

Fax

p.gates@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

Registering a new trial?

Documents added manually

Documents added automatically