Linking Hospitalized Injection Drug Users to Buprenorphine

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

147 participants

Study Classification

INTERVENTIONAL

Study Start Date

2009-09-30

Study Completion Date

2015-09-30

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

Onsite Buprenorphine Treatment at Syringe Exchange Programs

NCT03150173

Opiate Addiction

COMPLETED PHASE2

Buprenorphine and Integrated HIV Care

NCT00317460

COMPLETED PHASE4

Buprenorphine and Integrated HIV Care Evaluation

NCT00124358

UNKNOWN PHASE4

Interim Buprenorphine Treatment to Bridge Waitlist Delays: Stage II Evaluation

NCT03420313

Opioid-use Disorder

UNKNOWN PHASE2

Integrating Buprenorphine Into HIV Treatment

NCT00241930

Opiate Dependence HIV Infections

UNKNOWN PHASE4

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Opiate Dependence

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Treatment as usual

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

Group Type NO_INTERVENTION

No interventions assigned to this group

Linkage

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.

Group Type EXPERIMENTAL

Linkage

Intervention Type BEHAVIORAL

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

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Linkage

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

Intervention Type BEHAVIORAL

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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.

Minimum Eligible Age

18 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No