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Completed

NCT Number: NCT00987961

Linking Hospitalized Injection Drug Users to Buprenorphine

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.

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Key information

Conditions

Opiate Dependence Chemically-Induced Disorders Mental Disorders Narcotic-Related Disorders Opioid-Related Disorders Substance-Related Disorders

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Boston Medical Center

Boston, Massachusetts, 02118, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Linkage

Behavioral

This intervention provides an outpatient appointment with a Suboxone provider for medically hospitalized opioid-dependent patients to attend post-discharge.

Primary outcomes

  1. opioid use

    Time frame: baseline, 1-month, 3-months, 6-months

  2. HIV risk behavior

    Time frame: baseline, 1-month, 3-months, 6-months

Secondary outcomes

  1. reduction in injection-related medical conditions

    Time frame: baseline, 1-month, 3-months, 6-months

  2. reduction in emergency department and hospital utilization

    Time frame: baseline, 1-month, 3-months, 6-months

Sponsors and collaborators

Lead sponsor

Butler Hospital

Other

Collaborators

  • Boston Medical Center

Registry information

Important dates

Study start
2009
Primary completion
2014
Study completion
2015
First posted
Oct 1, 2009
Registry last updated
Nov 11, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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