Linking Hospitalized Injection Drug Users to Buprenorphine
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| ClinicalTrials.gov Identifier: NCT00987961 |
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Recruitment Status
:
Completed
First Posted
: October 1, 2009
Last Update Posted
: November 11, 2015
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Sponsor:
Butler Hospital
Collaborator:
Boston Medical Center
Information provided by (Responsible Party):
Michael Stein, MD, Butler Hospital
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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.
| Condition or disease | Intervention/treatment | Phase |
|---|---|---|
| Opiate Dependence | Behavioral: Linkage | Phase 3 |
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.
| Study Type : | Interventional (Clinical Trial) |
| Actual Enrollment : | 147 participants |
| Allocation: | Randomized |
| Intervention Model: | Parallel Assignment |
| Masking: | None (Open Label) |
| Primary Purpose: | Treatment |
| Official Title: | Linking Hospitalized Injection Drug Users to Buprenorphine |
| Study Start Date : | September 2009 |
| Actual Primary Completion Date : | March 2014 |
| Actual Study Completion Date : | September 2015 |
Resource links provided by the National Library of Medicine
Genetics Home Reference related topics:
Opioid addiction
Drug Information available for:
Buprenorphine
U.S. FDA Resources
| Arm | Intervention/treatment |
|---|---|
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No Intervention: Treatment as usual
Participants in this arm will receive the standard detox treatment for individuals hospitalized with opioid dependence.
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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.
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Behavioral: Linkage
This intervention provides an outpatient appointment with a Suboxone provider for medically hospitalized opioid-dependent patients to attend post-discharge.
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Primary Outcome Measures
:
- opioid use [ Time Frame: baseline, 1-month, 3-months, 6-months ]
- HIV risk behavior [ Time Frame: baseline, 1-month, 3-months, 6-months ]
Secondary Outcome Measures
:
- reduction in injection-related medical conditions [ Time Frame: baseline, 1-month, 3-months, 6-months ]
- reduction in emergency department and hospital utilization [ Time Frame: baseline, 1-month, 3-months, 6-months ]
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| Ages Eligible for Study: | 18 Years to 75 Years (Adult, Senior) |
| Sexes Eligible for Study: | All |
| 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.
Information from the National Library of Medicine
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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 |
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
| Responsible Party: | Michael Stein, MD, Principal Investigator, Butler Hospital |
| ClinicalTrials.gov Identifier: | NCT00987961 History of Changes |
| Other Study ID Numbers: |
1R01DA026223 ( U.S. NIH Grant/Contract ) |
| First Posted: | October 1, 2009 Key Record Dates |
| Last Update Posted: | November 11, 2015 |
| Last Verified: | November 2015 |
Keywords provided by Michael Stein, MD, Butler Hospital:
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opioid dependence suboxone HIV risk behavior |
Additional relevant MeSH terms:
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Opioid-Related Disorders Substance-Related Disorders Chemically-Induced Disorders Mental Disorders Buprenorphine Buprenorphine, Naloxone Drug Combination Analgesics, Opioid |
Narcotics Central Nervous System Depressants Physiological Effects of Drugs Analgesics Sensory System Agents Peripheral Nervous System Agents Narcotic Antagonists |