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Opiate AddictionPhase 3NCT00175357

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

A Phase 3 study testing Methadone and Diamorphine hydrochloride in people with Opiate Addiction, run by University of British Columbia at 2 sites in Canada.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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… Read more about this study

Who is it for?
Ages 25 years and older
Conditions the study is for
Opiate Addiction
What is being tested?
Methadone and Diamorphine hydrochloride
Type of treatment
Pill or oral medicine
Could I receive a placebo?
No, everyone receives an active treatment
How many people
192 participants
Where
2 sitesCanada
Study dates
Mar 2005to Apr 2009
Phase
Phase 3
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 25 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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
Show all 10Show fewer
  • 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.

Who cannot join

  • 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
Show all 9Show fewer
  • 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.

Trial locations and contacts

2 sites in 1 country.

Canada2 sites

  • University of Montreal

    Montreal, Quebec

  • University of British Columbia Faculty of Medicine

    Vancouver, British Columbia

Other trials in Canada

About this study

Official title: 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.

Read the 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.

Being tested
Methadone, Diamorphine hydrochloride
Keywords
Opiate addiction, medical heroin, methadoneRCT
Medical subject headings
Opioid-Related Disorders

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • MethadoneDrug

    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.

  • Diamorphine hydrochlorideDrug

    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.

Study groups in NCT00175357
Study groupRoleWhat they receive
1Active comparatorOral methadone
Receives: Drug: Methadone
2ExperimentalInjected diacetylmorphine
Receives: Drug: Diamorphine hydrochloride

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Recruitment and retention in the study at 12 months

    Measured: 12 months

  2. Illicit drug use and criminal behavior at 12 months.

    Measured: 12 months

Secondary outcomes (1)

  1. social integration, functioning, quality of life at 12 and 24 months; and cost-effectiveness at 12 months

    Measured: 24 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted15 Sep 2005 (estimated)
  2. Study startMar 2005
  3. Primary completionApr 2007
  4. Study completionApr 2009

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
192 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00175357
Sponsor's protocol ID
P99-0209
Other IDs
03-2316
Status last verified
Sep 2014
First submitted
9 Sep 2005
Last updated
29 Sep 2014
Results posted
No
Data monitoring committee
Yes

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.

    PubMed 25262567

  • 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.

    PubMed 24908387

  • 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.

    PubMed 22276954

  • 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.

    PubMed 21791093

  • 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.

    PubMed 19692689

  • 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.

    PubMed 19159475

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Methadone and Diamorphine hydrochloride in people with Opiate Addiction, run by University of British Columbia at 2 sites in Canada.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 10 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 29 Sep 2014. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 sites in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Recruitment and retention in the study at 12 months (time frame: 12 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00175357, which also lists 6 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Sep 2014.

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