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ANZCTR Newsletter Issue 5, Dec 2009 National and multinational prospective trial registers - The Lancet commentary En route to international clinical trial transparency - The Lancet commentary Declaration of Helsinki now has trial registration requirement (paragraph 19) The 2007 National Health and Medical Research Council (NHMRC) revised National Statement on Ethical Conduct in Human Research includes clause regarding trial registration (page 36, section 3.3.12) The 2007 NHMRC Australian Code for the Responsible Conduct of Research includes a clause regarding trial registration (section 4.10). This Code applies to all NHMRC funded trials The National Ethics Application Form (NEAF) now includes a question regarding details of trial registration (Question 9.1.8.4) ICMJE expands scope of registration ANZCTR is one of the first Primary Registers in the WHO Register Network (Search Portal)
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Trial Details
indicate updates made to monitored data item(s) since trial registration. These data item(s) are monitored to ensure they comply with the WHO / journal editors standards.
 
Request Number: 001462
ACTR Number: ACTRN12606000308594
Trial Status: Registered
Date Submitted: 19/07/2006
Date Registered: 20/07/2006

Page 1

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
ANZCTR registration title: A randomised double blind placebo controlled clinical trial of naltrexone implants for the treatment of heroin addiction
Secondary ID: 
UTN:
Trial acronym:

Page 2

Health condition(s) or problem(s) studied:
Heroin dependence 
Condition category: Condition code:
Mental Health Addiction 

Page 3

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:Treatment: drugs 
Comparator / control treatment: Double Placebo
Control group: Active

Page 4

Primary outcome 1:Proportion with blood naltrexone concentrations above therapeutic levels (2 ng/ml) 
Timepoint: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:baseline to 6 months 
Secondary outcome 1:Opiate related morbidity (hospital admissions) and mortality to 6 months 
Timepoint:baseline to 6 months 
Secondary outcome 2:Craving for heroin questionnaire (Tiffany). 
Timepoint:Measured at 0, 1, 2, 3, 4, 5, & 6 months. 
Secondary outcome 3:Proportion returning to dependent heroin/opiate use (DSM IV criteria). 
Timepoint:At 6 months. 
Secondary outcome 4:Frequency of other drug use. 
Timepoint: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:baseline to 6 months 
Secondary outcome 6:Opiate Treatment Index scores. 
Timepoint:At 0, 1, 2, 3, 4, 5, & 6 months. 

Page 5

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
Gender: Both males and females
Healthy volunteers? No
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.

Page 6
Study type: Interventional
Purpose of the study: Treatment
Allocation to intervention: Randomised controlled trial
Describe the procedure for enrolling a subject and allocating the treatment (allocation concealment procedures): Numbered containers
Describe the 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:
Assignment: Parallel
Other design features (specify):
Type of endpoint(s): Efficacy

Page 7
Phase Phase 2
Anticipated or actual start date: 4/01/2006
Target sample size: 70
Recruitment status: Closed: follow-up complete

Page 8

Funding source:Government funding body e.g. Australian Research Council 
Name:National Health & Medical Research Council 
Address:Canberra 
Country:Australia 
Primary sponsor: University
Name: University of Western Australia
Address: 35 Stirling Highway
Country: Australia
Secondary sponsor:None 
Name:n/a 
Address: 
Country: 
Other collaborator: 

Page 9

Has the study received approval from at least one ethics committee? Yes
Ethics Committee name:University of Western Australia HREC 
Address:35 Stirling Highway, Crawley 
Country:Australia 
Date of approval:29/03/2004 
HREC Number:RA/4/1/0739 
Countries of recruitment:Australia 
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:
Presentations / publication list:

Page 10

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
Tel: +61 8 9346 2281
Fax: +61 8 9346 3828
Email: robert.tait@uwa.edu.au

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
Tel: +61 8 9346 2280
Fax: +61 8 9346 3828
Email: gary.hulse@uwa.edu.au

Contact person responsible for updating information
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