NCT00175357

NAOMI: A Study to Compare Medically-prescribed Heroin With Oral Methadone in Chronic Opiate Addiction

North American Opiate Medication Initiative (NAOMI): Multi-Centre, Randomized Controlled Trial of Heroin-Assisted Therapy for Treatment-Refractory Injection Opiate Users

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 192 (actual)
• Sponsor: University of British Columbia · Academic / Other
• Sex: All
• Age: 25 Years
• Healthy volunteers: Not accepted

Summary

The objective of this study is to determine whether the closely supervised provision of injectable, pharmaceutical-grade heroin (in combination with oral methadone) is more effective than methadone therapy alone in recruiting, retaining, and benefiting long-term heroin users who have not been helped by current standard treatment options.

Detailed description

This is a two-centre (Vancouver, Montreal) RCT involving a total of 235 volunteers. Eligible participants will be randomized to injectable heroin combined with oral methadone as desired (45%) versus oral methadone alone (45%). A subset of 10% will be randomized to injectable hydromorphone (Dilaudid™). Hydromorphone and heroin will be given in a double-blind fashion; the purpose is to permit validation of reported illicit use of heroin through urine testing in the hydromorphone group. Research visits will be conducted quarterly and will occur independently of treatment clinic visits. Incentives will be used to maintain research follow-up whether or not the subject is retained in treatment. The analysis will be under intent-to-treat. The primary outcomes of interest are 1) recruitment and retention in the study and 2) illicit drug use and criminal behavior (as determined by the Europ-ASI) at 12 months. Secondary outcomes are measures of social function (e.g., social integration and functioning, quality of life) and cost-benefit/effectiveness of the interventions.

Conditions

• Opiate Addiction

Interventions

Type	Name	Description
DRUG	Methadone	The dose of the drug will be determined by a physician. The oral drug will be administered 1 dose per days, 7 days per week.
DRUG	Diamorphine hydrochloride	The dose of the drug will be determined by a physician. The injected drug will be administered up to 3 doses per day, 7 days per week.

Timeline

• Start date: 2005-03-01
• Primary completion: 2007-04-01
• Completion: 2009-04-01
• First posted: 2005-09-15
• Last updated: 2014-09-29

Locations

2 sites across 1 country: Canada