Clinical trial NCT00987961: Linking Hospitalized Injection Drug Users to Buprenorphine
Official title: Linking Hospitalized Injection Drug Users to Buprenorphine
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Opiate Dependence
Keywords: opioid dependence
suboxone
HIV risk behavior
Lead sponsor: Butler Hospital
Sponsor class: OTHER
Collaborators: name: Boston Medical Center
First posted: 2009-10-01
Enrollment: 147
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility 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.

Primary outcomes:
measure: opioid use
timeFrame: baseline, 1-month, 3-months, 6-months
measure: HIV risk behavior
timeFrame: baseline, 1-month, 3-months, 6-months
Secondary outcomes:
measure: reduction in injection-related medical conditions
timeFrame: baseline, 1-month, 3-months, 6-months
measure: reduction in emergency department and hospital utilization
timeFrame: baseline, 1-month, 3-months, 6-months
Other outcomes:
Locations:
city: Boston
country: United States
facility: Boston Medical Center
state: Massachusetts
Study officials:
affiliation: Butler Hospital
name: Michael D Stein, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.