ANZCTR - Registration

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Trial registered on ANZCTR

Registration number

ACTRN12606000308594

Ethics application status

Approved

Date submitted

19/07/2006

Date registered

20/07/2006

Date last updated

14/10/2008

Type of registration

Retrospectively registered

Titles & IDs

Public title

A randomised double blind placebo controlled clinical trial of the efficacy of an Australian naltrexone implant compared to oral naltrexone for the long-term management of heroin-dependent persons

Scientific title

A randomised double blind placebo controlled clinical trial of naltrexone implants for the treatment of heroin addiction

Universal Trial Number (UTN)

Trial acronym

Linked study record

Health condition

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

Heroin dependence

Condition category

Condition code

Mental Health

Addiction

Intervention/exposure

Study type

Interventional

Description of intervention(s) / exposure

A randomised, double placebo, double blind trial comparing the O’Neil long acting naltrexone subcutaneous implant (3.6g release rate 0.4% / day) plus placebo capsule with placebo implant plus capsules containing 50mg naltrexone hydrochloride. Participants will receive the intervention and data will be collected for a total of 6 months.

Intervention code [1]

Treatment: Drugs

Comparator / control treatment

Double Placebo

Control group

Active

Outcomes

Primary outcome [1]

Proportion with blood naltrexone concentrations above therapeutic levels (2 ng/ml)

Timepoint [1]

Measured at 1, 2, 3, 4, 5, & 6 months

Primary outcome [2]

Number of accidental opiate overdoses (hospital admissions or ED presentations) to 6 months

Timepoint [2]

baseline to 6 months

Secondary outcome [1]

Opiate related morbidity (hospital admissions) and mortality to 6 months

Timepoint [1]

baseline to 6 months

Secondary outcome [2]

Craving for heroin questionnaire (Tiffany).

Timepoint [2]

Measured at 0, 1, 2, 3, 4, 5, & 6 months.

Secondary outcome [3]

Proportion returning to dependent heroin/opiate use (DSM IV criteria).

Timepoint [3]

At 6 months.

Secondary outcome [4]

Frequency of other drug use.

Timepoint [4]

At 0, 1, 2, 3, 4, 5, & 6 months.

Secondary outcome [5]

Other drug related accidental overdose, other morbidity (hospital admission or ED presentation) or mortality to 6 months

Timepoint [5]

baseline to 6 months

Secondary outcome [6]

Opiate Treatment Index scores.

Timepoint [6]

At 0, 1, 2, 3, 4, 5, & 6 months.

Eligibility

Key inclusion criteria

Heroin dependence (DSM-IV criteria which covers the previous 12 months)Resident in the Perth (Western Australia) metropolitan area or regional areas with approved study support services Willing and able to provide written informed consentWilling to be randomised to either arm of the studySatisfactory completion of screening questionnaire.

Minimum age

18 Years

Maximum age

No limit

Sex

Both males and females

Can healthy volunteers participate?

Key exclusion criteria

High risk of overdose (3+ overdoses in previous month)Non compliant with oral naltrexone (4 + times in last 3 months) or prior implantPregnancyContra indications or prior adverse reactions for study medications/procedures.

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)

Numbered containers

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

Randomisation was based on computer generated random numbers, using a variable block size with a unified allocation ratio

Masking / blinding

Blinded (masking used)

Who is / are masked / blinded?

Intervention assignment

Parallel

Other design features

Phase

Phase 2

Type of endpoint/s

Efficacy

Statistical methods / analysis

Recruitment

Recruitment status

Completed

Date of first participant enrolment

Anticipated

4/01/2006

Actual

Date of last participant enrolment

Anticipated

Actual

Date of last data collection

Anticipated

Actual

Sample size

Target

Accrual to date

Final

Recruitment in Australia

Recruitment state(s)

Funding & Sponsors

Funding source category [1]

Government body

Name [1]

National Health & Medical Research Council

Address [1]

Canberra

Country [1]

Australia

Primary sponsor type

University

Name

University of Western Australia

Address

35 Stirling Highway

Country

Australia

Secondary sponsor category [1]

None

Name [1]

n/a

Address [1]

Country [1]

Ethics approval

Ethics application status

Approved

Ethics committee name [1]

University of Western Australia HREC

Ethics committee address [1]

35 Stirling Highway,
Crawley

Ethics committee country [1]

Australia

Date submitted for ethics approval [1]

Approval date [1]

29/03/2004

Ethics approval number [1]

RA/4/1/0739

Summary

Brief summary

GoMedical Industries has developed a formulation of sustained release naltrexone, suitable for subcutaneous depot administration. Currently, implants are inserted by minor surgery under local anaesthetic in high risk patients under the Therapeutic Goods Administration (TGA) Special Access Category A scheme (SAS) through the Australian Medical Procedures Research Foundation (AMPRF), Western Australia. Although there is a preliminary basis for believing that this naltrexone implant treatment may offer significant benefits over oral and other naltrexone depot preparations thus far reported for managing the heroin dependent patient, this needs to be verified through a clinical trial. Hence, the main objective of this study is to provide rigorous clinical data using a double blind, double placebo controlled study, on the effectiveness of this naltrexone implant compared to oral naltrexone in the management of heroin dependent persons by primarily monitoring: maintenance of blood naltrexone and 6-b-naltrexol concentrations above therapeutic levels; prevention of accidental opiate overdose; reduced opiate use; reduced opiate related morbidity and mortality; reduced craving for heroin and other health related outcomes.

Trial website

Trial related presentations / publications

Public notes

Contacts

Principal investigator

Name

Address

Country

Phone

Fax

Contact person for public queries

Name

Dr Robert Tait

Address

School of Psychiatry & Clinical Neurosciences,
University of Western Australia,
QE II Medical Centre, MPC 521,
Nedlands, Perth SA

Country

Australia

Phone

+61 8 9346 2281

Fax

+61 8 9346 3828

[email protected]

Contact person for scientific queries

Name

Professor Gary Hulse

Address

School of Psychiatry & Clinical Neurosciences
University of Western Australia
QE II Medical Centre MPC 521
Nedlands Perth

Country

Australia

Phone

+61 8 9346 2280

Fax

+61 8 9346 3828

[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

Source	Title	Year of Publication	DOI
Dimensions AI	Improving Clinical Outcomes in Treating Heroin Dependence: Randomized, Controlled Trial of Oral or Implant Naltrexone	2009	https://doi.org/10.1001/archgenpsychiatry.2009.130

N.B. These documents automatically identified may not have been verified by the study sponsor.

Trial Review

Documents added manually

Documents added automatically