- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00175357
NAOMI: A Study to Compare Medically-prescribed Heroin With Oral Methadone in Chronic Opiate Addiction
September 25, 2014 updated by: University of British Columbia
North American Opiate Medication Initiative (NAOMI): Multi-Centre, Randomized Controlled Trial of Heroin-Assisted Therapy for Treatment-Refractory Injection Opiate Users
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.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
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 Type
Interventional
Enrollment (Actual)
192
Phase
- Phase 3
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
British Columbia
-
Vancouver, British Columbia, Canada
- University of British Columbia Faculty of Medicine
-
-
Quebec
-
Montreal, Quebec, Canada
- University of Montreal
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
25 years and older (ADULT, OLDER_ADULT)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: TREATMENT
- Allocation: RANDOMIZED
- Interventional Model: PARALLEL
- Masking: NONE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
ACTIVE_COMPARATOR: 1
Oral 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
|
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.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Recruitment and retention in the study at 12 months
Time Frame: 12 months
|
12 months
|
Illicit drug use and criminal behavior at 12 months.
Time Frame: 12 months
|
12 months
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
social integration, functioning, quality of life at 12 and 24 months; and cost-effectiveness at 12 months
Time Frame: 24 months
|
24 months
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Collaborators
Investigators
- Principal Investigator: Martin T Schechter, MD, PhD, University of British Columbia
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
General Publications
- Oviedo-Joekes E, Marchand K, Lock K, Chettiar J, Marsh DC, Brissette S, Anis AH, Schechter MT. A chance to stop and breathe: participants' experiences in the North American Opiate Medication Initiative clinical trial. Addict Sci Clin Pract. 2014 Sep 29;9(1):21. doi: 10.1186/1940-0640-9-21.
- Oviedo-Joekes E, Guh D, Marchand K, Marsh DC, Lock K, Brissette S, Anis AH, Schechter MT. Differential long-term outcomes for voluntary and involuntary transition from injection to oral opioid maintenance treatment. Subst Abuse Treat Prev Policy. 2014 Jun 8;9:23. doi: 10.1186/1747-597X-9-23.
- Marchand K, Oviedo-Joekes E, Guh D, Marsh DC, Brissette S, Schechter MT. Sex work involvement among women with long-term opioid injection drug dependence who enter opioid agonist treatment. Harm Reduct J. 2012 Jan 25;9:8. doi: 10.1186/1477-7517-9-8.
- 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. doi: 10.1186/1472-6963-11-174.
- 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. doi: 10.1056/NEJMoa0810635.
- Gartry CC, Oviedo-Joekes E, Laliberte N, Schechter MT. NAOMI: The trials and tribulations of implementing a heroin assisted treatment study in North America. Harm Reduct J. 2009 Jan 21;6:2. doi: 10.1186/1477-7517-6-2.
Helpful Links
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
March 1, 2005
Primary Completion (ACTUAL)
April 1, 2007
Study Completion (ACTUAL)
April 1, 2009
Study Registration Dates
First Submitted
September 9, 2005
First Submitted That Met QC Criteria
September 9, 2005
First Posted (ESTIMATE)
September 15, 2005
Study Record Updates
Last Update Posted (ESTIMATE)
September 29, 2014
Last Update Submitted That Met QC Criteria
September 25, 2014
Last Verified
September 1, 2014
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
- Mental Disorders
- Chemically-Induced Disorders
- Substance-Related Disorders
- Narcotic-Related Disorders
- Compulsive Behavior
- Impulsive Behavior
- Opioid-Related Disorders
- Behavior, Addictive
- Physiological Effects of Drugs
- Central Nervous System Depressants
- Peripheral Nervous System Agents
- Analgesics
- Sensory System Agents
- Analgesics, Opioid
- Narcotics
- Respiratory System Agents
- Antitussive Agents
- Methadone
- Heroin
Other Study ID Numbers
- P99-0209
- 03-2316
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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