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Linking Hospitalized Injection Drug Users to Buprenorphine

Linking Hospitalized Injection Drug Users to Buprenorphine

Status
Completed
Phases
Phase 3
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT00987961
Enrollment
147
Registered
2009-10-01
Start date
2009-09-30
Completion date
2015-09-30
Last updated
2015-11-11

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Opiate Dependence

Keywords

opioid dependence, suboxone, HIV risk behavior

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.

Interventions

BEHAVIORALLinkage

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

Sponsors

Boston Medical Center
CollaboratorOTHER
Butler Hospital
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No

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.

Design outcomes

Primary

MeasureTime frame
opioid usebaseline, 1-month, 3-months, 6-months
HIV risk behaviorbaseline, 1-month, 3-months, 6-months

Secondary

MeasureTime frame
reduction in injection-related medical conditionsbaseline, 1-month, 3-months, 6-months
reduction in emergency department and hospital utilizationbaseline, 1-month, 3-months, 6-months

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Mar 7, 2026