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

NCT00175357 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 192

Last updated 2014-09-29

No results posted yet for this study

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.

Conditions

  • Opiate Addiction

Interventions

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.

Sponsors & Collaborators

  • Canadian Institutes of Health Research (CIHR)

    collaborator OTHER_GOV

  • University of British Columbia

    lead OTHER

Principal Investigators

  • Martin T Schechter, MD, PhD · University of British Columbia

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
25 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2005-03-31
Primary Completion
2007-04-30
Completion
2009-04-30

Countries

  • Canada

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00175357 on ClinicalTrials.gov