NCT00124358

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
1,350

participants targeted

Target at P75+ for phase_4

Timeline
Completed

Started Aug 2005

Typical duration for phase_4

Geographic Reach
1 country

10 active sites

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

July 25, 2005

Completed
2 days until next milestone

First Posted

Study publicly available on registry

July 27, 2005

Completed
5 days until next milestone

Study Start

First participant enrolled

August 1, 2005

Completed
3.3 years until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2008

Completed
Last Updated

March 27, 2007

Status Verified

March 1, 2007

First QC Date

July 25, 2005

Last Update Submit

March 23, 2007

Conditions

Opioid-Related DisordersHIV InfectionsAIDS

Keywords

Drug AbuseDrug AddictionDrug DependenceDrug Use DisordersDrug Use DisorderSubstance AbuseSubstance Use DisorderBuprenorphineOpiate AddictionSubstance-related disordersHIV

Outcome Measures

Primary Outcomes (3)

  • Substance use outcomes at 1, 3 and 6 months measured by self-report

  • Urine toxicology results at 1, 3, 6, and 12 months

  • Retention in and adherence to HIV care at 1, 3, 6, and 12 months

Secondary Outcomes (2)

  • Quality of life at 1, 3, 6, 9, and 12 months

  • HIV-related health outcomes at 1, 3, 6, 9, and 12 months

Interventions

BuprenorphineDRUG
Integrated HIV care and office-based opioid dependence treatmentBEHAVIORAL

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • HIV-infected
  • Clinical diagnosis of opioid dependence
  • Fluent in English or Spanish
  • years or older

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (10)

El Rio Santa Cruz Neighborhood Health Center

Tucson, Arizona, 85745, United States

RECRUITING

Organization to Achieve Solutions in Substance Abuse

Oakland, California, 94612, United States

RECRUITING

University of California San Francisco

San Francisco, California, 94110, United States

RECRUITING

Yale University School of Medicine AIDS Program

New Haven, Connecticut, 06510, United States

RECRUITING

University of Miami School of Medicine

Miami, Florida, 33136, United States

RECRUITING

The CORE Center

Chicago, Illinois, 60612, United States

RECRUITING

Johns Hopkins University

Baltimore, Maryland, 21287, United States

RECRUITING

Montefiore Medical Center

New York, New York, 10467, United States

RECRUITING

Oregon Health & Science University

Portland, Oregon, 97239, United States

RECRUITING

The Miriam Hospital

Providence, Rhode Island, 02903, United States

RECRUITING

Related Links

MeSH Terms

Conditions

Opioid-Related DisordersHIV InfectionsAcquired Immunodeficiency SyndromeSubstance-Related Disorders

Interventions

Buprenorphine

Condition Hierarchy (Ancestors)

Narcotic-Related DisordersChemically-Induced DisordersMental DisordersBlood-Borne InfectionsCommunicable DiseasesInfectionsSexually Transmitted Diseases, ViralSexually Transmitted DiseasesLentivirus InfectionsRetroviridae InfectionsRNA Virus InfectionsVirus DiseasesGenital DiseasesUrogenital DiseasesImmunologic Deficiency SyndromesImmune System DiseasesSlow Virus Diseases

Intervention Hierarchy (Ancestors)

MorphinansOpiate AlkaloidsAlkaloidsHeterocyclic CompoundsHeterocyclic Compounds, Bridged-RingHeterocyclic Compounds, 4 or More RingsHeterocyclic Compounds, Fused-RingPhenanthrenesPolycyclic Aromatic HydrocarbonsPolycyclic Compounds

Study Officials

  • Ruth Finkelstein, ScD

    New York Academy of Medicine

    PRINCIPAL INVESTIGATOR

  • David Fiellin, MD

    Yale University

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Ruth Finkelstein, ScD

CONTACT

212.822.7266rfinkelstein@nyam.org

James E Egan, MPH

CONTACT

212.822.7347jegan@nyam.org

Study Design

Study Type
interventional
Phase
phase 4
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

July 25, 2005

First Posted

July 27, 2005

Study Start

August 1, 2005

Study Completion

December 1, 2008

Last Updated

March 27, 2007

Record last verified: 2007-03

Locations

US(10)