Linking Hospitalized Injection Drug Users to Buprenorphine

Butler Hospital

Status and phase: Completed; Phase 3

Conditions: Opiate Dependence

Treatments: Behavioral: Linkage

Study type: Interventional

Funder types: Other

Identifiers

NCT00987961

1R01DA026223

Details and patient eligibility

About

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.

Full 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.

Enrollment: 147 patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No 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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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147 participants in 2 patient groups

Treatment as usual

No Intervention group

Description:

Participants in this arm will receive the standard detox treatment for individuals hospitalized with opioid dependence.

Linkage

Experimental group

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.

Treatment:

Behavioral: Linkage