Linking Hospitalized Injection Drug Users to Buprenorphine

This study is ongoing, but not recruiting participants.

Sponsor:

Collaborator:

Boston Medical Center

Information provided by (Responsible Party):

Michael Stein, MD, Butler Hospital

ClinicalTrials.gov Identifier:

NCT00987961

First received: September 30, 2009

Last updated: July 16, 2014

Last verified: July 2014

History of Changes

Purpose

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.

Condition	Intervention	Phase
Opiate Dependence	Behavioral: Linkage	Phase 4


Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Treatment
Official Title:	Linking Hospitalized Injection Drug Users to Buprenorphine

Resource links provided by NLM:

MedlinePlus related topics: HIV/AIDS

U.S. FDA Resources

Further study details as provided by Butler Hospital:

Primary Outcome Measures:

opioid use [ Time Frame: baseline, 1-month, 3-months, 6-months ] [ Designated as safety issue: No ]
HIV risk behavior [ Time Frame: baseline, 1-month, 3-months, 6-months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

reduction in injection-related medical conditions [ Time Frame: baseline, 1-month, 3-months, 6-months ] [ Designated as safety issue: No ]
reduction in emergency department and hospital utilization [ Time Frame: baseline, 1-month, 3-months, 6-months ] [ Designated as safety issue: No ]


Estimated Enrollment:	195
Study Start Date:	September 2009
Estimated Study Completion Date:	December 2014
Estimated Primary Completion Date:	December 2014 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
No Intervention: Treatment as usual Participants in this arm will receive the standard detox treatment for individuals hospitalized with opioid dependence.
Experimental: 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.	Behavioral: Linkage This intervention provides an outpatient appointment with a Suboxone provider for medically hospitalized opioid-dependent patients to attend post-discharge.

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.

Eligibility


Ages Eligible for Study:	18 Years to 75 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

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.

Contacts and Locations

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00987961

Locations


United States, Massachusetts
Boston Medical Center
Boston, Massachusetts, United States, 02118

Sponsors and Collaborators

Butler Hospital

Boston Medical Center

Investigators


Principal Investigator:	Michael D Stein, MD	Butler Hospital

More Information

No publications provided by Butler Hospital

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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.

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.


Responsible Party:	Michael Stein, MD, Principal Investigator, Butler Hospital
ClinicalTrials.gov Identifier:	NCT00987961 History of Changes
Other Study ID Numbers:	1 R01 DA 026223
Study First Received:	September 30, 2009
Last Updated:	July 16, 2014
Health Authority:	United States: Institutional Review Board

Keywords provided by Butler Hospital:


opioid dependence suboxone HIV risk behavior

ClinicalTrials.gov processed this record on March 03, 2015

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