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

Sponsors and Collaborators:	University of British Columbia Canadian Institutes of Health Research (CIHR)
Information provided by:	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 III

Drug Information available for: Methadone Methadone hydrochloride Diacetylmorphine Diacetylmorphine hydrochloride

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Open Label, Active Control, Parallel Assignment, Efficacy Study
Official Title:	North American Opiate Medication Initiative (NAOMI): Multi-Centre, Randomized Controlled Trial of Heroin-Assisted Therapy for Treatment-Refractory Injection Opiate Users

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:	December 2010
Estimated Primary Completion Date:	December 2010 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
1: Active Comparator 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.
2: Experimental 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

Contacts

Contact: Candice Gartry

604-806-8409

Locations

Canada, British Columbia
University of British Columbia Faculty of Medicine	Recruiting
Vancouver, British Columbia, Canada
Contact: Candice Gartry 604-806-8409
Principal Investigator: Martin T Schechter, MD, PhD
Canada, Quebec
University of Montreal	Recruiting
Montreal, Quebec, Canada
Contact: Pascal Schneeberger 514-890-8000 ext 35341
Principal Investigator: Suzanne Brissette

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

Related Info This link exits the ClinicalTrials.gov site

Responsible Party:	University of British Columbia ( Dr. Martin Schechter )
Study ID Numbers:	P99-0209, 03-2316
Study First Received:	September 9, 2005
Last Updated:	September 23, 2008
ClinicalTrials.gov Identifier:	NCT00175357
Health Authority:	Canada: Health Canada

Keywords provided by University of British Columbia:

Opiate addiction
medical heroin
methadoneRCT

Study placed in the following topic categories:

Behavior, Addictive
Heroin
Disorders of Environmental Origin
Impulsive Behavior
Opioid-Related Disorders
Naphazoline
Compulsive Behavior

Methadone
Oxymetazoline
Guaifenesin
Mental Disorders
Phenylephrine
Substance-Related Disorders
Phenylpropanolamine

Additional relevant MeSH terms:

Respiratory System Agents
Sensory System Agents
Therapeutic Uses
Physiological Effects of Drugs
Central Nervous System Depressants
Narcotics

Peripheral Nervous System Agents
Analgesics
Antitussive Agents
Central Nervous System Agents
Pharmacologic Actions
Analgesics, Opioid

ClinicalTrials.gov processed this record on January 16, 2009