Linking Hospitalized Injection Drug Users to Buprenorphine

Study Overview
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Brief Summary
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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
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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.

Official Title
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Linking Hospitalized Injection Drug Users to Buprenorphine

Conditions
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Opiate Dependence

Intervention / Treatment
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* Behavioral: Linkage


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| No Intervention: Treatment as usual<br>Participants in this arm will receive the standard detox treatment for individuals hospitalized with opioid dependence. | |
| Experimental: Linkage<br>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. | Behavioral: Linkage<br>* This intervention provides an outpatient appointment with a Suboxone provider for medically hospitalized opioid-dependent patients to attend post-discharge.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| opioid use |  | baseline, 1-month, 3-months, 6-months | 
| HIV risk behavior |  | baseline, 1-month, 3-months, 6-months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| reduction in injection-related medical conditions |  | baseline, 1-month, 3-months, 6-months | 
| reduction in emergency department and hospital utilization |  | baseline, 1-month, 3-months, 6-months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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opioid dependence, suboxone, HIV risk behavior