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

Sponsor:	University of British Columbia
Collaborator:	Canadian Institutes of Health Research (CIHR)
Information provided by (Responsible Party):	University of British Columbia
ClinicalTrials.gov Identifier:	NCT00175357

Purpose

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.

Condition	Intervention	Phase
Opiate Addiction	Drug: Methadone Drug: Diamorphine hydrochloride	Phase 3

Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Treatment
Official Title:	North American Opiate Medication Initiative (NAOMI): Multi-Centre, Randomized Controlled Trial of Heroin-Assisted Therapy for Treatment-Refractory Injection Opiate Users

Resource links provided by NLM:

Drug Information available for: Methadone Methadone hydrochloride

U.S. FDA Resources

Further study details as provided by University of British Columbia:

Primary Outcome Measures:

Recruitment and retention in the study at 12 months [ Time Frame: 12 months ] [ Designated as safety issue: No ]
Illicit drug use and criminal behavior at 12 months. [ Time Frame: 12 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

social integration, functioning, quality of life at 12 and 24 months; and cost-effectiveness at 12 months [ Time Frame: 24 months ] [ Designated as safety issue: No ]

Estimated Enrollment:	253
Study Start Date:	March 2005
Estimated Study Completion Date:	June 2012
Primary Completion Date:	June 2008 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Active Comparator: 1 Oral methadone	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.
Experimental: 2 Injected diacetylmorphine	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.

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.

Eligibility

Ages Eligible for Study:	25 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

Opioid Dependence as confirmed by DSM-IV diagnostic criteria
25 years of age or older
5 years or more of opioid use
Regular opioid injection use in the past month and in at least 8 months in the past 12 months (self reported; regular use - defined as injecting opioids for at least 4 days or more in a week); 50% or more of the injections during the prior year must have involved heroin).
Minimum of one-year residence in site/city location
No enrollment in any other opioid substitution (e.g. methadone) program within the prior 6 months - enrollment is defined as having received at least 45 milligrams of prescribed methadone per day on any 30 consecutive days or more in the prior 6 months
At least two previous episodes of opiate addiction treatment (methadone maintenance, detoxification, residential care, etc) during which, on at least one occasion, the patient received at least 60 mg of methadone daily for at least 30 days in a 40 day period
Willingness and ability to adhere to study protocol and follow-up schedule as determined through the three-week pre-randomization period (see Section C.4)
Documentation of fulfillment of the above study criteria (prison records, treatment records, cohort study enrollment, urine sampling)
Provide written and informed consent.

Exclusion Criteria:

Diagnosis of severe medical or psychiatric conditions that are contra-indicated for heroin treatment
Pregnancy upon study entry
On parole or with current justice system involvement that is likely to result in an extended period of incarceration (more than 4 months) during the study period (e.g. scheduled trial for an indictable offense, jail, etc)
Hydromorphone is a class C teratogen and should not be given to pregnant women. All female subjects upon study entry will be urged to engage only in protected sexual intercourse and will provide consent to undergo monthly pregnancy tests during the course of the study.
Serum bilirubin >2.5 x normal
Stage II or greater hepatic encephalopathy
Chronic respiratory disease resulting in resting respiratory rate >20/minute
Bipolar Mood Disorder, Schizophrenia or other psychotic disorder with active psychotic symptoms within the past 6 months
Major Depression refractory to medical management or requiring electroconvulsive therapy within the past 12 months.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00175357

Locations

Canada, British Columbia
University of British Columbia Faculty of Medicine
Vancouver, British Columbia, Canada
Canada, Quebec
University of Montreal
Montreal, Quebec, Canada

Sponsors and Collaborators

University of British Columbia

Canadian Institutes of Health Research (CIHR)

Investigators

Principal Investigator:

Martin T Schechter, MD, PhD

University of British Columbia

More Information

Additional Information:

Related Info This link exits the ClinicalTrials.gov site

No publications provided by University of British Columbia

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Marchand KI, Oviedo-Joekes E, Guh D, Brissette S, Marsh DC, Schechter MT. Client satisfaction among participants in a randomized trial comparing oral methadone and injectable diacetylmorphine for long-term opioid-dependency. BMC Health Serv Res. 2011 Jul 26;11:174.

Oviedo-Joekes E, Brissette S, Marsh DC, Lauzon P, Guh D, Anis A, Schechter MT. Diacetylmorphine versus methadone for the treatment of opioid addiction. N Engl J Med. 2009 Aug 20;361(8):777-86.

Responsible Party:	University of British Columbia
ClinicalTrials.gov Identifier:	NCT00175357 History of Changes
Other Study ID Numbers:	P99-0209, 03-2316
Study First Received:	September 9, 2005
Last Updated:	October 4, 2011
Health Authority:	Canada: Health Canada

Keywords provided by University of British Columbia:

Opiate addiction
medical heroin
methadoneRCT

Additional relevant MeSH terms:

Behavior, Addictive
Opioid-Related Disorders
Compulsive Behavior
Impulsive Behavior
Substance-Related Disorders
Mental Disorders
Heroin
Methadone
Analgesics, Opioid
Analgesics

Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Pharmacologic Actions
Central Nervous System Agents
Therapeutic Uses
Central Nervous System Depressants
Narcotics
Antitussive Agents
Respiratory System Agents

ClinicalTrials.gov processed this record on May 21, 2012