Recruiting

Buprenorphine & HIV Care

Sponsor:

The New York Academy of Medicine

Code:

NCT00124358

Conditions

Opioid-Related Disorders

HIV Infections

AIDS

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Buprenorphine

Integrated HIV care and office-based opioid dependence treatment

Study Details

Brief summary:

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.

Conditions

Opioid-Related Disorders

HIV Infections

AIDS

Study ID

NCT00124358

Start date

Aug, 2005

Status verified date

Mar, 2007

Completion date

Dec, 2008

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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

Study Design

Enrollment

1350 participants

Allocation

Non randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Interventions

Buprenorphine

Integrated HIV care and office-based opioid dependence treatment

Primary outcome measure

  • Substance use outcomes at 1, 3 and 6 months measured by self-report [ Time Frame: undefined ]
  • Urine toxicology results at 1, 3, 6, and 12 months [ Time Frame: undefined ]
  • Retention in and adherence to HIV care at 1, 3, 6, and 12 months [ Time Frame: undefined ]

Central Contacts and Locations

Central contacts

Ruth Finkelstein, ScD

212.822.7266rfinkelstein@nyam.org

James E Egan, MPH

212.822.7347jegan@nyam.org

Locations

El Rio Santa Cruz Neighborhood Health Center

Recruiting

Tucson, Arizona, United States, 85745

Contacts

Jeff Thomas, ACSW

520-629-2888jefft@elrio.org

Principal Investigator:

Kevin Carmichael, MD

Organization to Achieve Solutions in Substance Abuse

Recruiting

Oakland, California, United States, 94612

Contacts

Laphyne Barrett, MA

510-834-5442

Principal Investigator:

Diana Sylvestre

University of California San Francisco

Recruiting

San Francisco, California, United States, 94110

Contacts

Bob Thawley

415-476-9296rthawley@php.ucsf.edu

Principal Investigator:

Paula Lum, MD, MPH

Yale University School of Medicine AIDS Program

Recruiting

New Haven, Connecticut, United States, 06510

Contacts

Declan Barry, PhD

203-781-4650declan.barry@yale.edu

Principal Investigator:

Frederick Altice, MD

University of Miami School of Medicine

Recruiting

Miami, Florida, United States, 33136

Contacts

Leslie Thompson, RN, BSN

305-243-3838lthomps@gate.net

Principal Investigator:

Margaret Fischl, MD

The CORE Center

Recruiting

Chicago, Illinois, United States, 60612

Contacts

Mary Jo Tozzi

312-572-4818mtozzi@corecenter.org

Principal Investigator:

Jeffrey Watts, MD

Johns Hopkins University

Recruiting

Baltimore, Maryland, United States, 21287

Contacts

Greg Lucas, MD, PhD

410-614-0560glucas@jhmi.edu

Principal Investigator:

Greg Lucas, MD, PhD

Montefiore Medical Center

Recruiting

New York, New York, United States, 10467

Contacts

Galit Sacajiu, MD

gsacajiu@montefiore.org

Principal Investigator:

Chinazo Cunningham, MD

Oregon Health & Science University

Recruiting

Portland, Oregon, United States, 97239

Contacts

Catherine Pedersen, MPA

503-494-6770

Principal Investigator:

P. Todd Korthuis, MD, MPH

The Miriam Hospital

Recruiting

Providence, Rhode Island, United States, 02903

Contacts

Helen Loewenthal, MSW

401-793-4824hloewenthal@lifespan.org

Principal Investigator:

Timothy Flanigan, MD

More Information

Sponsor

The New York Academy of Medicine

Last update posted

Mar 27, 2007

Last verified

Mar, 2007

Keywords

  • Drug Abuse
  • Drug Addiction
  • Drug Dependence
  • Drug Use Disorders
  • Drug Use Disorder
  • Substance Abuse
  • Substance Use Disorder
  • Buprenorphine
  • Opiate Addiction
  • Substance-related disorders
  • HIV

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-08. This information was provided to ClinicalTrials.gov by The New York Academy of Medicine on 2007-03-27.