Linking Hospitalized Injection Drug Users to Buprenorphine
![]() |
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. |
ClinicalTrials.gov Identifier: NCT00987961 |
Recruitment Status
:
Completed
First Posted
: October 1, 2009
Last Update Posted
: November 11, 2015
|
- Study Details
- Tabular View
- No Results Posted
- Disclaimer
- How to Read a Study Record
Condition or disease | Intervention/treatment | Phase |
---|---|---|
Opiate Dependence | Behavioral: Linkage | Phase 3 |
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 |

Arm | Intervention/treatment |
---|---|
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.
|
- opioid use [ Time Frame: baseline, 1-month, 3-months, 6-months ]
- HIV risk behavior [ Time Frame: baseline, 1-month, 3-months, 6-months ]
- 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 ]

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, Learn About Clinical Studies.
Ages Eligible for Study: | 18 Years to 75 Years (Adult, Senior) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
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.

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
United States, Massachusetts | |
Boston Medical Center | |
Boston, Massachusetts, United States, 02118 |
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:
opioid dependence suboxone HIV risk behavior |
Additional relevant MeSH terms:
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 |