Conditions:
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
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:
Phase: Phase 4
First Received: July 25, 2005
Last Updated: Aug 07, 2009
Clinicaltrials.gov ID:
NCT00124358
Study HIC # 0510000681
Conditions:
Interventions: Drug: Buprenorphine;
Behavioral: Integrated HIV care and office-based opioid dependence treatment
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.
Date: August 2005
Study Status: Recruiting
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:
Phase: Phase 4
First Received: July 25, 2005
Last Updated: Aug 07, 2009
Clinicaltrials.gov ID:
NCT00124358
Study HIC # 0510000681
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
Altice, Frederick
Principal Investigator
Fiellin, David A.
Principal Investigator
Sullivan, Lynn E
Principal Investigator
HIC # 0805003779