Trial from ANZCTR


Trial ID ACTRN12606000308594
Trial Status: Registered
Date Submitted: 19/07/2006
Date Registered: 20/07/2006
Retrospectively registered

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
Update:
 
Reason:
 
Study title in 'Participant- Intervention- Comparator- Outcome (PICO)' format A randomised double blind placebo controlled clinical trial of naltrexone implants for the treatment of heroin addiction
Update:
 
Reason:
 
UTN
Update:
 
Reason:
 
Trial acronym
Update:
 

Page 2

Health condition(s) or problem(s) studied:
Heroin dependence 1279 0
 Update:
 Reason:
Condition category: Condition code:
Mental Health Addiction
 Update:
 Update:
  Reason:
1366 1366 0 0

Page 3

Descriptions 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.
Update:
 
Reason:
 
Intervention Code:
Treatment: drugs 1203 0
Update:
 
Reason:
 
Comparator / control treatment Double Placebo
Update:
 
Reason:
 
Control group Active
Update:
 
Reason:
 

Page 4

Primary Outcome: Proportion with blood naltrexone concentrations above therapeutic levels (2 ng/ml) 1867 0
Update:
 
Reason:
 
Timepoint: Measured at 1, 2, 3, 4, 5, & 6 months 1867 0
Update:
 
Reason:
 
Primary Outcome: Number of accidental opiate overdoses (hospital admissions or ED presentations) to 6 months 1868 0
Update:
 
Reason:
 
Timepoint: baseline to 6 months 1868 0
Update:
 
Reason:
 
Secondary Outcome: Opiate related morbidity (hospital admissions) and mortality to 6 months 3284 0
Update:
 
Reason:
 
Timepoint: baseline to 6 months 3284 0
Update:
 
Reason:
 
Secondary Outcome: Craving for heroin questionnaire (Tiffany). 3285 0
Update:
 
Reason:
 
Timepoint: Measured at 0, 1, 2, 3, 4, 5, & 6 months. 3285 0
Update:
 
Reason:
 
Secondary Outcome: Proportion returning to dependent heroin/opiate use (DSM IV criteria). 3286 0
Update:
 
Reason:
 
Timepoint: At 6 months. 3286 0
Update:
 
Reason:
 
Secondary Outcome: Frequency of other drug use. 3287 0
Update:
 
Reason:
 
Timepoint: At 0, 1, 2, 3, 4, 5, & 6 months. 3287 0
Update:
 
Reason:
 
Secondary Outcome: Other drug related accidental overdose, other morbidity (hospital admission or ED presentation) or mortality to 6 months 3288 0
Update:
 
Reason:
 
Timepoint: baseline to 6 months 3288 0
Update:
 
Reason:
 
Secondary Outcome: Opiate Treatment Index scores. 3289 0
Update:
 
Reason:
 
Timepoint: At 0, 1, 2, 3, 4, 5, & 6 months. 3289 0
Update:
 
Reason:
 

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.
Update:
 
Reason:
 
Minimum age 18 Years
Update:
 
Reason:
 
Update:
 
Reason:
 
Maximum age No limit
Update:
 
Reason:
 
Update:
 
Reason:
 
Gender Both males and females
Update:
 
Reason:
 
Healthy volunteers? No
Update:
 
Reason:
 
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.
Update:
 
Reason:
 

Page 6

Study type Interventional
Update:
 
Reason:
 
Purpose of the study Treatment
Update:
 
Allocation to intervention Randomised controlled trial
Update:
 
Reason:
 
Describe the procedure for enrolling a subject and allocating the treatment (allocation concealment procedures) Numbered containers
Update:
 
Reason:
 
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
Update:
 
Reason:
 
Masking / blinding Blinded (masking used)
Update:
 
Reason:
 
Who is / are masked / blinded (choose all that apply)


Update:
       
Reason:
 
Assignment Parallel
Update:
 
Reason:
 
Other design features
Update:
 
Reason:
 
Type of endpoint(s) Efficacy
Update:
 
Reason:
 
Statistical Methods/Analysis
Update:
 
Reason:
 

Page 7

Phase Phase 2
Update:
 
Reason:
 
Anticipated date of first participant enrolment 4/01/2006
Update:
 
Reason:
 
Date of first participant enrolment
Update:
 
Reason:
 
Anticipated date last participant recruited/enrolled
Update:
 
Reason:
 
Actual date last participant recruited/enrolled
Update:
 
Reason:
 
Target sample size 70
Update:
 
Reason:
 
Recruitment status Closed: follow-up complete
Update:
 
Reason:
 

Recruitment in Australia

Recruitment state(s)
Update:
 
Reason:
 

Recruitment outside Australia

Page 8

Funding Source: Government body 1501 0
Update:
 
Reason:
 
Name: National Health & Medical Research Council 1501 0
Update:
 
Reason:
 
Address: Canberra 1501 0
Update:
 
Reason:
 
Country: Australia 1501 0
Update:
 
Reason:
 
Primary Sponsor University
Update:
 
Reason:
 
Name: University of Western Australia
Update:
 
Reason:
 
Address: 35 Stirling Highway
Update:
 
Reason:
 
Country: Australia
Update:
 
Reason:
 
Secondary Sponsor: None 1318 0
Update:
 
Reason:
 
Name: n/a 1318 0
Update:
 
Reason:
 
Address: 1318 0
Update:
 
Reason:
 
Country: 1318 0
Update:
 
Reason:
 

Page 9

Has the study received approval from at least one Ethics Committee? Yes
Update:
 
Reason:
 
Ethics Committee name: University of Western Australia HREC 2923 0
Update:
 
Reason:
 
Address: 35 Stirling Highway,
Crawley
2923 0
Update:
 
Reason:
 
Country: Australia 2923 0
Update:
 
Reason:
 
Approval Date: 29/03/2004 2923 0
Update:
 
Reason:
 
Submitted Date: 2923 0
Update:
 
Reason:
 
HREC: RA/4/1/0739 2923 0
Update:
 
Reason:
 
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.
Update:
 
Reason:
 
Trial website
Update:
 
Trial related presentations / publications
Update:
 
Public Notes
Update:
 

Page 10

Principal Investigator
Title:
Update:
 
Reason:
 
35302 0
Name:
Update:
 
Reason:
 
35302 0
Address:
Update:
 
Reason:
 
35302 0
Country:
Update:
 
35302 0
Reason:
 
Tel:
Update:
 
Reason:
 
35302 0
Fax:
Update:
 
Reason:
 
35302 0
Email:
Update:
 
Reason:
 
35302 0
Contact person for public queries
Title:
Update:
 
Reason:
 
10392 0
Name: Dr Robert Tait
Update:
 
Reason:
 
10392 0
Address: School of Psychiatry & Clinical Neurosciences, University of Western Australia, QE II Medical Centre, MPC 521, Nedlands, Perth SA
Update:
 
Reason:
 
10392 0
Country: Australia
Update:
 
10392 0
Reason:
 
Tel: +61 8 9346 2281
Update:
 
Reason:
 
10392 0
Fax: +61 8 9346 3828
Update:
 
Reason:
 
10392 0
Email: robert.tait@uwa.edu.au
Update:
 
Reason:
 
10392 0

Contact person for scientific queries
Title:
Update:
 
Reason:
 
1320 0
Name: Professor Gary Hulse
Update:
 
Reason:
 
1320 0
Address: School of Psychiatry & Clinical Neurosciences University of Western Australia QE II Medical Centre MPC 521 Nedlands Perth
Update:
 
Reason:
 
1320 0
Country: Australia
Update:
 
1320 0
Reason:
 
Tel: +61 8 9346 2280
Update:
 
Reason:
 
1320 0
Fax: +61 8 9346 3828
Update:
 
Reason:
 
1320 0
Email: gary.hulse@uwa.edu.au
Update:
 
Reason:
 
1320 0

Contact person responsible for updating information
Title:
Update:
 
Reason:
 
19464 0
Name:
Update:
 
Reason:
 
19464 0
Address:
Update:
 
Reason:
 
19464 0
Country:
Update:
 
19464 0
Reason:
 
Tel:
Update:
 
Reason:
 
19464 0
Fax:
Update:
 
Reason:
 
19464 0
Email:
Update:
 
Reason:
 
19464 0
   

Addition Cancer fields
Update:
 
Reason:
 
Update:
 
Reason:
 
Update:
 
Reason:
 
Update:
 
Reason:
 
Update:
 
Reason:
 
Update:
 
Reason: