Yale School of Medicine

Research Studies at Yale

Research Studies at Yale

Buprenorphine and Integrated HIV Care Evaluation

For Patients For Researchers

Conditions: AIDS; HIV Infections; Opioid-Related Disorders; Suboxone

What is the purpose of this trial?

The purpose of this study is to assess the feasibility, cost and effectiveness of interventions designed to integrate buprenorphine treatment for opioid dependence into HIV primary care in ten HIV care centers in the U.S.


Start Date: August 2005
Study Status: Recruiting

Who can participate?

Ages Eligible: 18 Years and older
Gender Eligible: Both

Inclusion Criteria:

- HIV-infected

- Clinical diagnosis of opioid dependence

- Fluent in English or Spanish

- 18 years or older

Exclusion Criteria:

- Liver function tests (transaminase only) at five times or higher than normal level;

- Diagnostic and Statistical Manual of Mental Disorders-Fourth Edition (DSM-IV)
criteria for benzodiazepine abuse or dependence within the past 6 months;

- DSM-IV criteria for alcohol dependence within the past 6 months;

- Actively suicidal;

- Psychiatric impairment that impedes ability to consent (dementia, delusional,
actively psychotic);

- Methadone dose exceeding levels allowing for safe transition to buprenorphine;

- Pregnant women and women actively trying to become pregnant;

- Clinical judgment of local site principal investigator that patient is inappropriate

Sponsors: Brown University, CORE Center, Cook County Bureau of Health Services, El Rio Santa Cruz Neighborhood Health Center, Health Resources & Services Administration, Johns Hopkins University, Montefiore Medical Center, Oregon Health and Science University, Organization to Achieve Solutions in Substance Abuse (OASIS), The New York Academy of Medicine, University of California, San Francisco, University of Miami, Yale University
Phase: Phase 4

First Received: July 25, 2005 
Last Updated: Aug 07, 2009
Clinicaltrials.gov ID: NCT00124358
Study HIC # 0510000681

Conditions: AIDS; HIV Infections; Opioid-Related Disorders; Suboxone

Interventions: Drug: Buprenorphine;
Behavioral: Integrated HIV care and office-based opioid dependence treatment

What is the purpose of this trial?

The purpose of this study is to assess the feasibility, cost and effectiveness of interventions designed to integrate buprenorphine treatment for opioid dependence into HIV primary care in ten HIV care centers in the U.S.


show additional information...

Date: August 2005
Study Status: Recruiting

Who can participate?

Ages Eligible: 18 Years and older
Gender Eligible: Both

Inclusion Criteria:

- HIV-infected

- Clinical diagnosis of opioid dependence

- Fluent in English or Spanish

- 18 years or older

Exclusion Criteria:

- Liver function tests (transaminase only) at five times or higher than normal level;

- Diagnostic and Statistical Manual of Mental Disorders-Fourth Edition (DSM-IV)
criteria for benzodiazepine abuse or dependence within the past 6 months;

- DSM-IV criteria for alcohol dependence within the past 6 months;

- Actively suicidal;

- Psychiatric impairment that impedes ability to consent (dementia, delusional,
actively psychotic);

- Methadone dose exceeding levels allowing for safe transition to buprenorphine;

- Pregnant women and women actively trying to become pregnant;

- Clinical judgment of local site principal investigator that patient is inappropriate


Additional Locations

Arizona

California

Florida

Illinois

Maryland

New York

Oregon

Rhode Island

Sponsors: Brown University, CORE Center, Cook County Bureau of Health Services, El Rio Santa Cruz Neighborhood Health Center, Health Resources & Services Administration, Johns Hopkins University, Montefiore Medical Center, Oregon Health and Science University, Organization to Achieve Solutions in Substance Abuse (OASIS), The New York Academy of Medicine, University of California, San Francisco, University of Miami, Yale University
Phase: Phase 4

First Received: July 25, 2005 
Last Updated: Aug 07, 2009
Clinicaltrials.gov ID: NCT00124358
Study HIC # 0510000681

Participate in this trial

For more information about this trial, contact:

Declan Barry, PhD
203-781-4650 Ext. 250
declan.barry@yale.edu

James E Egan, MPH
212.822.7347
jegan@nyam.org

Ruth Finkelstein, ScD
212.822.7266
rfinkelstein@nyam.org


Yale Researchers

Altice, Frederick
Principal Investigator  

Fiellin, David A.
Principal Investigator  

Sullivan, Lynn E
Principal Investigator  

HIC # 0805003779