Linking Hospitalized Injection Drug Users to Buprenorphine

Opiate Dependence Clinical Trial

Official title:

Linking Hospitalized Injection Drug Users to Buprenorphine

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00987961
• Other study ID #: 1R01DA026223
• Status: Completed
• Phase: Phase 3
• First received: September 30, 2009
• Last updated: November 10, 2015
• Start date: September 2009
• Est. completion date: September 2015

Study information

• Verified date: November 2015
• Source: Butler Hospital
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial Summary

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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 147
• Est. completion date: September 2015
• Est. primary completion date: March 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 75 Years

Eligibility

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.

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Opiate Dependence

Intervention

Behavioral:
• Linkage
This intervention provides an outpatient appointment with a Suboxone provider for medically hospitalized opioid-dependent patients to attend post-discharge.

Locations

Country	Name	City	State
United States	Boston Medical Center	Boston	Massachusetts

Sponsors (2)

Lead Sponsor	Collaborator
Butler Hospital	Boston Medical Center

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	opioid use		baseline, 1-month, 3-months, 6-months	No
Primary	HIV risk behavior		baseline, 1-month, 3-months, 6-months	No
Secondary	reduction in injection-related medical conditions		baseline, 1-month, 3-months, 6-months	No
Secondary	reduction in emergency department and hospital utilization		baseline, 1-month, 3-months, 6-months	No