Linking Hospitalized Injection Drug Users to Buprenorphine
This study is ongoing, but not recruiting participants.
Sponsor:
Butler Hospital
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: March 11, 2013
Last verified: March 2013
- Full Text View
- Tabular View
- No Study Results Posted
- Disclaimer
- How to Read a Study Record
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:
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 2013 |
| Estimated Primary Completion Date: | December 2013 (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
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
| 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: | March 11, 2013 |
| Health Authority: | United States: Institutional Review Board |
Keywords provided by Butler Hospital:
|
opioid dependence suboxone HIV risk behavior |
Additional relevant MeSH terms:
|
Opioid-Related Disorders Substance-Related Disorders Mental Disorders Buprenorphine Analgesics, Opioid Analgesics Sensory System Agents Peripheral Nervous System Agents |
Physiological Effects of Drugs Pharmacologic Actions Central Nervous System Agents Therapeutic Uses Central Nervous System Depressants Narcotic Antagonists Narcotics |
ClinicalTrials.gov processed this record on May 23, 2013