Study to Assess Longer-term Opioid Medication Effectiveness (SALOME)

PHASE3CompletedINTERVENTIONAL
Enrollment

202

Participants

Timeline

Start Date

December 31, 2011

Primary Completion Date

June 30, 2014

Study Completion Date

February 29, 2016

Conditions
Opioid DependenceHeroin Dependence
Interventions
DRUG

Hydromorphone, Injectable

Phase I: 3x daily, up to 500mg per day, for 6 months. Phase II: At 6 months, participants are randomized to either: 1) stay on injectable hydromorphone; 2) switch to oral hydromorphone, for another 6 months.

DRUG

Diacetylmorphine, injectable

Phase I: 3x daily, up to 1,000mg per day, for 6 months. Phase II: At 6 months, participants are randomized to either: 1) stay on injectable diacetylmorphine; 2) switch to oral diacetylmorphine, for another 6 months.

DRUG

Hydromorphone, liquid oral

Study Phase II: After 6 months of receiving Hydromorphone injectable , participants will be randomized to stay on injectable hydromorphone or switch to oral hydromorphone, for another six months. Oral = experimental; injectable = active comparator

DRUG

Diacetylmorphine, liquid oral

Study Phase II: After 6 months of receiving Diacetylmorphine injectable, participants will be randomized to stay on injectable Diacetylmorphine or switch to oral Diacetylmorphine, for another six months. Oral = experimental; injectable = active comparator

Trial Locations (1)

V6B 1C8

SALOME Research Office, Vancouver

All Listed Sponsors
collaborator

Canadian Institutes of Health Research (CIHR)

OTHER_GOV

collaborator

Providence Healthcare

OTHER

collaborator

Innerchange Charitable Society

UNKNOWN

lead

University of British Columbia

OTHER

NCT01447212 - Study to Assess Longer-term Opioid Medication Effectiveness (SALOME) | Biotech Hunter | Biotech Hunter