Buprenorphine and Integrated HIV Care

April 1, 2020 updated by: Yale University

On-Site Addiction Treatment With Buprenorphine in HIV Clinical Care Settings

The purpose of this study is to examine the efficacy of providing two levels of psychosocial support along with buprenorphine/naloxone (BUP) maintenance to opioid dependent patients receiving their care in an HIV clinical care setting.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

The purpose of this study is to examine the efficacy of providing two levels of psychosocial support along with buprenorphine/naloxone (BUP) maintenance to opioid dependent patients receiving their care in an HIV clinical care setting. The proposed study will compare Physician Management (PM), a manual-guided brief intervention that approximates the usual counseling provided by primary care practitioners to patients with chronic medical conditions vs. an enhanced strategy of PM with the addition of a combined drug counseling and adherence management strategy (PM+DC/AM). DC is designed to educate the patient about the recovery process and provide additional advice about lifestyle changes including HIV transmission risk reduction and 12-step participation. Adherence Management (AM) is a counseling strategy focusing on HIV medication adherence, adapted from Sorensen et al1. This research will build on pilot work that is being completed in order to further develop and refine these counseling interventions, determine what other psychosocial interventions might be required, and to evaluate this model of integrated care in terms of its effects on opioid agonist therapy retention, decreasing illicit drug use, and increasing adherence to highly active antiretroviral therapy (HAART). Finally, it will provide data that will aid in the formulation of guidelines and the creation of practical manuals for optimizing the provision of this novel therapy to individuals with HIV disease and opioid dependence, as well as provide data for future funded randomized clinical trials.

From September 2005 (start date) to December 1, 2007, the study was conducted as part of a multi-site project that was overseen by the New York Academy of Medicine (NYAM), which is in charge of data analysis. Following December 1, 2007, the study will continue as a local, single-site project without further collaboration from NYAM.

Study Type

Interventional

Enrollment (Actual)

52

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Connecticut
      • New Haven, Connecticut, United States, 06519
        • Yale University School Of Medicine

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • HIV disease
  • DSM-IV criteria for opioid dependence, as assessed by SCID
  • Documented opioid positive urine toxicology testing

Exclusion criteria:

  • Desire to remain enrolled in opioid agonist treatment at an opioid treatment program
  • Current dependence on alcohol, benzodiazepines or sedatives (patients who are receiving benzodiazepines under the care of a psychiatrist for the treatment of an anxiety disorder will not be excluded)
  • Current suicide or homicide risk
  • Current psychotic disorder or major depression
  • Inability to read or understand English
  • Dementia
  • Life-threatening or unstable medical problems requiring inpatient medical care or nursing home placement
  • Currently enrolled in other studies involving the provision of psychosocial treatment.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: 1
Physician Management
Other: Physician Management
Standard physician care
Experimental: 2
Physician Management and counseling (drug counseling and medication adherence)
Behavioral: Counseling
Physician Management and Counseling

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Treatment retention
Time Frame: 52 weeks
52 weeks
Reductions in illicit opioid use
Time Frame: 52 weeks
52 weeks
Adherence to antiretroviral medications
Time Frame: 52 weeks
52 weeks

Secondary Outcome Measures

Outcome Measure
Time Frame
T-lymphocyte CD4 cell count
Time Frame: 52 weeks
52 weeks
HIV-1 RNA levels
Time Frame: 52 weeks
52 weeks
Reduction in HIV transmission risk behaviors
Time Frame: 52 weeks
52 weeks
Improved health status
Time Frame: 52 weeks
52 weeks
Patient satisfaction
Time Frame: 52 weeks
52 weeks
Provider satisfaction
Time Frame: 52 weeks
52 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Yale University

Collaborators

The New York Academy of Medicine

Investigators

  • Study Director: Christopher J Cutter, Ph.D., Yale University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

September 1, 2005

Primary Completion (Actual)

October 1, 2009

Study Completion (Actual)

October 1, 2012

Study Registration Dates

First Submitted

April 20, 2006

First Submitted That Met QC Criteria

April 21, 2006

First Posted (Estimate)

April 24, 2006

Study Record Updates

Last Update Posted (Actual)

April 3, 2020

Last Update Submitted That Met QC Criteria

April 1, 2020

Last Verified

April 1, 2020

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 0510000681

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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