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Linking Hospitalized Injection Drug Users to Buprenorphine

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00987961
First Posted: October 1, 2009
Last Update Posted: November 11, 2015
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborator:
Boston Medical Center
Information provided by (Responsible Party):
Michael Stein, MD, Butler Hospital
  Purpose
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.

Condition Intervention Phase
Opiate Dependence Behavioral: Linkage Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Linking Hospitalized Injection Drug Users to Buprenorphine

Resource links provided by NLM:


Further study details as provided by Michael Stein, MD, Butler Hospital:

Primary Outcome Measures:
  • opioid use [ Time Frame: baseline, 1-month, 3-months, 6-months ]
  • HIV risk behavior [ Time Frame: baseline, 1-month, 3-months, 6-months ]

Secondary Outcome Measures:
  • reduction in injection-related medical conditions [ Time Frame: baseline, 1-month, 3-months, 6-months ]
  • reduction in emergency department and hospital utilization [ Time Frame: baseline, 1-month, 3-months, 6-months ]

Enrollment: 147
Study Start Date: September 2009
Study Completion Date: September 2015
Primary Completion Date: March 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.

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.
  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00987961


Locations
United States, Massachusetts
Boston Medical Center
Boston, Massachusetts, United States, 02118
Sponsors and Collaborators
Butler Hospital
Boston Medical Center
Investigators
Principal Investigator: Michael D Stein, MD Butler Hospital
  More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Michael Stein, MD, Principal Investigator, Butler Hospital
ClinicalTrials.gov Identifier: NCT00987961     History of Changes
Other Study ID Numbers: 1R01DA026223 ( U.S. NIH Grant/Contract )
First Submitted: September 30, 2009
First Posted: October 1, 2009
Last Update Posted: November 11, 2015
Last Verified: November 2015

Keywords provided by Michael Stein, MD, Butler Hospital:
opioid dependence
suboxone
HIV risk behavior

Additional relevant MeSH terms:
Opioid-Related Disorders
Substance-Related Disorders
Chemically-Induced Disorders
Mental Disorders
Buprenorphine
Buprenorphine, Naloxone Drug Combination
Analgesics, Opioid
Narcotics
Central Nervous System Depressants
Physiological Effects of Drugs
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Narcotic Antagonists


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