NCT00175357

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
192

participants targeted

Target at P25-P50 for phase_3

Timeline
Completed

Started Mar 2005

Typical duration for phase_3

Geographic Reach
1 country

2 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 1, 2005

Completed
6 months until next milestone

First Submitted

Initial submission to the registry

September 9, 2005

Completed
6 days until next milestone

First Posted

Study publicly available on registry

September 15, 2005

Completed
1.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2007

Completed
2 years until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2009

Completed
Last Updated

September 29, 2014

Status Verified

September 1, 2014

Enrollment Period

2.1 years

First QC Date

September 9, 2005

Last Update Submit

September 25, 2014

Conditions

Opiate Addiction

Keywords

Opiate addictionmedical heroinmethadoneRCT

Outcome Measures

Primary Outcomes (2)

  • Recruitment and retention in the study at 12 months

    12 months

  • Illicit drug use and criminal behavior at 12 months.

    12 months

Secondary Outcomes (1)

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

    24 months

Study Arms (2)

1

ACTIVE COMPARATOR

Oral methadone

Drug: Methadone

2

EXPERIMENTAL

Injected diacetylmorphine

Drug: Diamorphine hydrochloride

Interventions

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.

1
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.

2

Eligibility Criteria

Age25 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Opioid Dependence as confirmed by DSM-IV diagnostic criteria
  • years of age or older
  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

University of British Columbia Faculty of Medicine

Vancouver, British Columbia, Canada

Location

University of Montreal

Montreal, Quebec, Canada

Location

Related Publications (6)

  • 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.

    PMID: 25262567DERIVED

  • 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.

    PMID: 24908387DERIVED

  • 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.

    PMID: 22276954DERIVED

  • 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.

    PMID: 21791093DERIVED

  • 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.

    PMID: 19692689DERIVED

  • 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.

    PMID: 19159475DERIVED

Related Links

MeSH Terms

Conditions

Opioid-Related Disorders

Interventions

MethadoneHeroin

Condition Hierarchy (Ancestors)

Narcotic-Related DisordersSubstance-Related DisordersChemically-Induced DisordersMental Disorders

Intervention Hierarchy (Ancestors)

KetonesOrganic ChemicalsMorphine DerivativesMorphinansOpiate AlkaloidsAlkaloidsHeterocyclic CompoundsHeterocyclic Compounds, Bridged-RingHeterocyclic Compounds, 4 or More RingsHeterocyclic Compounds, Fused-RingPhenanthrenesPolycyclic Aromatic HydrocarbonsPolycyclic Compounds

Study Officials

  • Martin T Schechter, MD, PhD

    University of British Columbia

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 9, 2005

First Posted

September 15, 2005

Study Start

March 1, 2005

Primary Completion

April 1, 2007

Study Completion

April 1, 2009

Last Updated

September 29, 2014

Record last verified: 2014-09

Locations

CA(2)