Linking Hospitalized Injection Drug Users to Buprenorphine

November 10, 2015 updated by: Michael Stein, MD, Butler Hospital
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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

147

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Massachusetts
      • Boston, Massachusetts, United States, 02118
        • Boston Medical Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 75 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
No Intervention: Treatment as usual
Participants in this arm will receive the standard detox treatment for individuals hospitalized with opioid dependence.
Experimental: Linkage
Participants 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.
Behavioral: Linkage
This intervention provides an outpatient appointment with a Suboxone provider for medically hospitalized opioid-dependent patients to attend post-discharge.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
opioid use
Time Frame: baseline, 1-month, 3-months, 6-months
baseline, 1-month, 3-months, 6-months
HIV risk behavior
Time Frame: baseline, 1-month, 3-months, 6-months
baseline, 1-month, 3-months, 6-months

Secondary Outcome Measures

Outcome Measure
Time Frame
reduction in injection-related medical conditions
Time Frame: baseline, 1-month, 3-months, 6-months
baseline, 1-month, 3-months, 6-months
reduction in emergency department and hospital utilization
Time Frame: baseline, 1-month, 3-months, 6-months
baseline, 1-month, 3-months, 6-months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Butler Hospital

Collaborators

Boston Medical Center

Investigators

  • Principal Investigator: Michael D Stein, MD, Butler Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

September 1, 2009

Primary Completion (Actual)

March 1, 2014

Study Completion (Actual)

September 1, 2015

Study Registration Dates

First Submitted

September 30, 2009

First Submitted That Met QC Criteria

September 30, 2009

First Posted (Estimate)

October 1, 2009

Study Record Updates

Last Update Posted (Estimate)

November 11, 2015

Last Update Submitted That Met QC Criteria

November 10, 2015

Last Verified

November 1, 2015

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 1R01DA026223 (U.S. NIH Grant/Contract)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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