search
Back to results

Linking Hospitalized Injection Drug Users to Buprenorphine

Primary Purpose

Opiate Dependence

Status
Completed
Phase
Phase 3
Locations
United States
Study Type
Interventional
Intervention
Linkage
Sponsored by
Butler Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Opiate Dependence focused on measuring opioid dependence, suboxone, HIV risk behavior

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Boston Medical Center

Arms of the Study

Arm 1

Arm 2

Arm Type

No Intervention

Experimental

Arm Label

Treatment as usual

Linkage

Arm Description

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.

Outcomes

Primary Outcome Measures

opioid use
HIV risk behavior

Secondary Outcome Measures

reduction in injection-related medical conditions
reduction in emergency department and hospital utilization

Full Information

First Posted
September 30, 2009
Last Updated
November 10, 2015
Sponsor
Butler Hospital
Collaborators
Boston Medical Center
search

1. Study Identification

Unique Protocol Identification Number
NCT00987961
Brief Title
Linking Hospitalized Injection Drug Users to Buprenorphine
Official Title
Linking Hospitalized Injection Drug Users to Buprenorphine
Study Type
Interventional

2. Study Status

Record Verification Date
November 2015
Overall Recruitment Status
Completed
Study Start Date
September 2009 (undefined)
Primary Completion Date
March 2014 (Actual)
Study Completion Date
September 2015 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Butler Hospital
Collaborators
Boston Medical Center

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Opiate Dependence
Keywords
opioid dependence, suboxone, HIV risk behavior

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
147 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Treatment as usual
Arm Type
No Intervention
Arm Description
Participants in this arm will receive the standard detox treatment for individuals hospitalized with opioid dependence.
Arm Title
Linkage
Arm Type
Experimental
Arm Description
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 Type
Behavioral
Intervention Name(s)
Linkage
Intervention Description
This intervention provides an outpatient appointment with a Suboxone provider for medically hospitalized opioid-dependent patients to attend post-discharge.
Primary Outcome Measure Information:
Title
opioid use
Time Frame
baseline, 1-month, 3-months, 6-months
Title
HIV risk behavior
Time Frame
baseline, 1-month, 3-months, 6-months
Secondary Outcome Measure Information:
Title
reduction in injection-related medical conditions
Time Frame
baseline, 1-month, 3-months, 6-months
Title
reduction in emergency department and hospital utilization
Time Frame
baseline, 1-month, 3-months, 6-months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Michael D Stein, MD
Organizational Affiliation
Butler Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Boston Medical Center
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02118
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
25090173
Citation
Liebschutz JM, Crooks D, Herman D, Anderson B, Tsui J, Meshesha LZ, Dossabhoy S, Stein M. Buprenorphine treatment for hospitalized, opioid-dependent patients: a randomized clinical trial. JAMA Intern Med. 2014 Aug;174(8):1369-76. doi: 10.1001/jamainternmed.2014.2556.
Results Reference
derived
PubMed Identifier
24045030
Citation
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.
Results Reference
derived

Learn more about this trial

Linking Hospitalized Injection Drug Users to Buprenorphine

We'll reach out to this number within 24 hrs