MedPath

Linking Hospitalized Injection Drug Users to Buprenorphine

Phase 3
Completed
Conditions
Opiate Dependence
Interventions
Behavioral: Linkage
Registration Number
NCT00987961
Lead Sponsor
Butler Hospital
Brief Summary

This study tests whether starting Suboxone (buprenorphine) during a medical hospitalization, and then providing an appointment (a "link") for after discharge to maintenance buprenorphine in an outpatient setting will reduce HIV risk behavior in individuals who inject opioids.

Detailed Description

In this randomized controlled trial, medically hospitalized opioid dependent patients will be assigned to a "treatment as usual" group, where they will receive a detox regiment of Suboxone during their hospital stay, or a "linkage" group, where they receive a maintenance course of Suboxone during their hospital stay, and appointment post-discharge with an outpatient Suboxone clinic/provider and a Suboxone prescription to use between discharge and this appointment. Study interviews are completed at baseline, and 1, 3- and 6-months post-baseline. Primary outcomes are opioid use and HIV risk behavior.

Recruitment & Eligibility

Status
COMPLETED
Sex
All
Target Recruitment
147
Inclusion Criteria
  • 18 years of age or older
  • Current opioid injector, at least weekly in the past month
  • Current opioid dependence, SCID confirmed
  • Currently receiving an inpatient buprenorphine detoxification protocol.
Exclusion Criteria
  • Patients unable to be interviewed due to acute illness or cognitive impairment
  • In police custody, expecting incarceration
  • Persons who cannot provide two contact persons (including shelters, parole officers, etc.) to verify location
  • Not able to complete assessments in English
  • Enrolled in a methadone maintenance program
  • Plans to leave the area within the next 6 months.

Study & Design

Study Type
INTERVENTIONAL
Study Design
PARALLEL
Arm && Interventions
GroupInterventionDescription
LinkageLinkageParticipants in this arm will receive a maintenance schedule of Suboxone during their hospital stay, and an appointment with an outpatient Suboxone provider for after their discharge.
Primary Outcome Measures
NameTimeMethod
opioid usebaseline, 1-month, 3-months, 6-months
HIV risk behaviorbaseline, 1-month, 3-months, 6-months
Secondary Outcome Measures
NameTimeMethod
reduction in injection-related medical conditionsbaseline, 1-month, 3-months, 6-months
reduction in emergency department and hospital utilizationbaseline, 1-month, 3-months, 6-months

Trial Locations

Locations (1)

Boston Medical Center

🇺🇸

Boston, Massachusetts, United States

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