Linking Hospitalized Injection Drug Users to Buprenorphine

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborator:
Boston Medical Center
Information provided by (Responsible Party):
Michael Stein, MD, Butler Hospital
ClinicalTrials.gov Identifier:
NCT00987961
First received: September 30, 2009
Last updated: July 8, 2013
Last verified: July 2013

September 30, 2009
July 8, 2013
September 2009
December 2013   (final data collection date for primary outcome measure)
  • opioid use [ Time Frame: baseline, 1-month, 3-months, 6-months ] [ Designated as safety issue: No ]
  • HIV risk behavior [ Time Frame: baseline, 1-month, 3-months, 6-months ] [ Designated as safety issue: No ]
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 ] [ Designated as safety issue: No ]
  • reduction in emergency department and hospital utilization [ Time Frame: baseline, 1-month, 3-months, 6-months ] [ Designated as safety issue: No ]
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 4
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: 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
Meshesha LZ, Tsui JI, Liebschutz JM, Crooks D, Anderson BJ, Herman DS, Stein MD. Days of heroin use predict poor self-reported health in hospitalized heroin users. Addict Behav. 2013 Dec;38(12):2884-7. doi: 10.1016/j.addbeh.2013.08.002. Epub 2013 Aug 14.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Active, not recruiting
195
December 2013
December 2013   (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.
Both
18 Years to 75 Years
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00987961
1 R01 DA 026223
No
Michael Stein, MD, Butler Hospital
Butler Hospital
Boston Medical Center
Principal Investigator: Michael D Stein, MD Butler Hospital
Butler Hospital
July 2013

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