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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
September 30, 2009
October 1, 2009
November 11, 2015
September 2009
March 2014   (Final data collection date for primary outcome measure)
  • opioid use [ Time Frame: baseline, 1-month, 3-months, 6-months ]
  • HIV risk behavior [ Time Frame: baseline, 1-month, 3-months, 6-months ]
Same as current
Complete list of historical versions of study NCT00987961 on ClinicalTrials.gov Archive Site
  • 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 ]
Same as current
Not Provided
Not Provided
 
Linking Hospitalized Injection Drug Users to Buprenorphine
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.
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.
Interventional
Phase 3
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Opiate Dependence
Behavioral: Linkage
This intervention provides an outpatient appointment with a Suboxone provider for medically hospitalized opioid-dependent patients to attend post-discharge.
  • 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.
    Intervention: Behavioral: Linkage

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
147
September 2015
March 2014   (Final data collection date for primary outcome measure)

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.
Sexes Eligible for Study: All
18 Years to 75 Years   (Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
United States
 
 
NCT00987961
1R01DA026223( U.S. NIH Grant/Contract )
No
Not Provided
Not Provided
Michael Stein, MD, Butler Hospital
Butler Hospital
Boston Medical Center
Principal Investigator: Michael D Stein, MD Butler Hospital
Butler Hospital
November 2015

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP