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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00175357
Recruitment Status : Completed
First Posted : September 15, 2005
Last Update Posted : September 29, 2014
Sponsor:
Collaborator:
Canadian Institutes of Health Research (CIHR)
Information provided by (Responsible Party):
University of British Columbia

Study Description
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Brief 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.

Condition or disease Intervention/treatment Phase
Opiate Addiction Drug: Methadone Drug: Diamorphine hydrochloride Phase 3

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.
Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 192 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (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
Study Start Date : March 2005
Actual Primary Completion Date : April 2007
Actual Study Completion Date : April 2009

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
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.


Outcome Measures
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Primary Outcome Measures :
  1. Recruitment and retention in the study at 12 months [ Time Frame: 12 months ]
  2. Illicit drug use and criminal behavior at 12 months. [ Time Frame: 12 months ]

Secondary Outcome Measures :
  1. social integration, functioning, quality of life at 12 and 24 months; and cost-effectiveness at 12 months [ Time Frame: 24 months ]

Eligibility Criteria
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Ages Eligible for Study:   25 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Opioid Dependence as confirmed by DSM-IV diagnostic criteria
  2. 25 years of age or older
  3. 5 years or more of opioid use
  4. 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).
  5. Minimum of one-year residence in site/city location
  6. 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
  7. 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
  8. 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)
  9. Documentation of fulfillment of the above study criteria (prison records, treatment records, cohort study enrollment, urine sampling)
  10. Provide written and informed consent.

Exclusion Criteria:

  1. Diagnosis of severe medical or psychiatric conditions that are contra-indicated for heroin treatment
  2. Pregnancy upon study entry
  3. 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)
  4. 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.
  5. Serum bilirubin >2.5 x normal
  6. Stage II or greater hepatic encephalopathy
  7. Chronic respiratory disease resulting in resting respiratory rate >20/minute
  8. Bipolar Mood Disorder, Schizophrenia or other psychotic disorder with active psychotic symptoms within the past 6 months
  9. Major Depression refractory to medical management or requiring electroconvulsive therapy within the past 12 months.
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00175357


Locations
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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
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Principal Investigator: Martin T Schechter, MD, PhD University of British Columbia
More Information
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Additional Information:

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

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Responsible Party: University of British Columbia
ClinicalTrials.gov Identifier: NCT00175357    
Other Study ID Numbers: P99-0209
03-2316
First Posted: September 15, 2005    Key Record Dates
Last Update Posted: September 29, 2014
Last Verified: September 2014
Keywords provided by University of British Columbia:
Opiate addiction
medical heroin
methadoneRCT
Additional relevant MeSH terms:
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Opioid-Related Disorders
Behavior, Addictive
Compulsive Behavior
Impulsive Behavior
Narcotic-Related Disorders
Substance-Related Disorders
Chemically-Induced Disorders
Mental Disorders
Methadone
Heroin
 Analgesics, Opioid
Narcotics
Central Nervous System Depressants
Physiological Effects of Drugs
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Antitussive Agents
Respiratory System Agents