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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT00987961
Other study ID # 1R01DA026223
Secondary ID
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


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
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