drugset / Trial / NCT00175357

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

NCT00175357 ↗

RandomizedParallel-groupOpen-labelTreatment

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.

Timeline

Start
2005-03
Primary completion
2007-04
Completion
2009-04

Outcome

Met primary endpoint

paper rate of retention in addiction treatment in the diacetylmorphine group was 87.8%, as compared with 54.1% in the methadone group PMID 19692689 ↗

paper rate ratio for retention, 1.62; 95% confidence interval [CI], 1.35 to 1.95; P<0.001 PMID 19692689 ↗

paper The reduction in rates of illicit-drug use or other illegal activity was 67.0% in the diacetylmorphine group and 47.7% in the methadone group PMID 19692689 ↗

paper rate ratio, 1.40; 95% CI, 1.11 to 1.77; P=0.004 PMID 19692689 ↗

Publications

Drugs

EvaluationDrugModalityDoseRoute
Subject Diacetylmorphine Small molecule — Other
Comparator Methadone Other / unclassified — Oral

Indications