Linking Hospitalized Injection Drug Users to Buprenorphine

Condition(s) targeted: Opiate Dependence

Intervention: Linkage (Behavioral)

Phase: Phase 4

Status: Recruiting

Sponsored by: Butler Hospital

Official(s) and/or principal investigator(s):
Michael D Stein, MD, Principal Investigator, Affiliation: Butler Hospital

Overall contact:
Michael D Stein, MD, Phone: 401-455-6646, Email: michael_stein@brown.edu

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.

Official title: Linking Hospitalized Injection Drug Users to Buprenorphine

Study design: Treatment, Randomized, Open Label, Active Control, Parallel Assignment, Efficacy Study

Primary outcome:

opioid use

HIV risk behavior

Secondary outcome:

reduction in injection-related medical conditions

reduction in emergency department and hospital utilization

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.

Minimum age: 18 Years. Maximum age: 75 Years. Gender(s): Both.

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.

Michael D Stein, MD, Phone: 401-455-6646, Email: michael_stein@brown.edu

Boston Medical Center, Boston, Massachusetts 02118, United States; Recruiting
Michael D Stein, MD, Phone: 401-455-6646, Email: michael_stein@brown.edu
Debra S Herman, PhD, Phone: 401-455-6652, Email: dherman@butler.org
Jane Leibschutz, MD, Principal Investigator

Starting date: September 2009
Ending date: December 2013
Last updated: September 30, 2009