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

Phase 2

Completed

• Conditions: Heroin dependence; Mental Health - Addiction

• Registration Number: ACTRN12606000308594
• Lead Sponsor: niversity of Western Australia

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2006-07-20
• Last Update Posted: 13 January 2020

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 70

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.

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

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Proportion with blood naltrexone concentrations above therapeutic levels (2 ng/ml)[Measured at 1, 2, 3, 4, 5, & 6 months];Number of accidental opiate overdoses (hospital admissions or ED presentations) to 6 months[baseline to 6 months]

Secondary Outcome Measures

Name	Time	Method
Opiate related morbidity (hospital admissions) and mortality to 6 months[baseline to 6 months];Craving for heroin questionnaire (Tiffany). [Measured at 0, 1, 2, 3, 4, 5, & 6 months.];Proportion returning to dependent heroin/opiate use (DSM IV criteria).[At 6 months.];Frequency of other drug use.[At 0, 1, 2, 3, 4, 5, & 6 months.];Other drug related accidental overdose, other morbidity (hospital admission or ED presentation) or mortality to 6 months[baseline to 6 months];Opiate Treatment Index scores.[At 0, 1, 2, 3, 4, 5, & 6 months.]