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.
|Study Design:||Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||Linking Hospitalized Injection Drug Users to Buprenorphine|
- 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 ]
- 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 ]
|Study Start Date:||September 2009|
|Estimated Study Completion Date:||December 2014|
|Estimated Primary Completion Date:||December 2014 (Final data collection date for primary outcome measure)|
No Intervention: Treatment as usual
Participants in this arm will receive the standard detox treatment for individuals hospitalized with opioid dependence.
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.
This intervention provides an outpatient appointment with a Suboxone provider for medically hospitalized opioid-dependent patients to attend post-discharge.
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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00987961
|United States, Massachusetts|
|Boston Medical Center|
|Boston, Massachusetts, United States, 02118|
|Principal Investigator:||Michael D Stein, MD||Butler Hospital|