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Buprenorphine and Integrated HIV Care

Primary Purpose

Substance-related Disorders, Drug Addiction, Human Immunodeficiency Virus

Status
Completed
Phase
Phase 4
Locations
United States
Study Type
Interventional
Intervention
Physician Management
Counseling
Sponsored by
Yale University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Substance-related Disorders focused on measuring Drug Abuse, Drug Addiction, Drug Dependence, Drug Use Disorders, Drug Use Disorder, Substance Abuse, Substance Use Disorder, Buprenorphine, Opiate Addiction

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Yale University School of Medicine

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

1

2

Arm Description

Physician Management

Physician Management and counseling (drug counseling and medication adherence)

Outcomes

Primary Outcome Measures

Treatment retention
Reductions in illicit opioid use
Adherence to antiretroviral medications

Secondary Outcome Measures

T-lymphocyte CD4 cell count
HIV-1 RNA levels
Reduction in HIV transmission risk behaviors
Improved health status
Patient satisfaction
Provider satisfaction

Full Information

First Posted
April 20, 2006
Last Updated
April 1, 2020
Sponsor
Yale University
Collaborators
The New York Academy of Medicine
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1. Study Identification

Unique Protocol Identification Number
NCT00317460
Brief Title
Buprenorphine and Integrated HIV Care
Official Title
On-Site Addiction Treatment With Buprenorphine in HIV Clinical Care Settings
Study Type
Interventional

2. Study Status

Record Verification Date
April 2020
Overall Recruitment Status
Completed
Study Start Date
September 2005 (undefined)
Primary Completion Date
October 2009 (Actual)
Study Completion Date
October 2012 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Yale University
Collaborators
The New York Academy of Medicine

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Substance-related Disorders, Drug Addiction, Human Immunodeficiency Virus, AIDS, HIV Infections
Keywords
Drug Abuse, Drug Addiction, Drug Dependence, Drug Use Disorders, Drug Use Disorder, Substance Abuse, Substance Use Disorder, Buprenorphine, Opiate Addiction

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
52 (Actual)

8. Arms, Groups, and Interventions

Arm Title
1
Arm Type
Active Comparator
Arm Description
Physician Management
Arm Title
2
Arm Type
Experimental
Arm Description
Physician Management and counseling (drug counseling and medication adherence)
Intervention Type
Other
Intervention Name(s)
Physician Management
Intervention Description
Standard physician care
Intervention Type
Behavioral
Intervention Name(s)
Counseling
Intervention Description
Physician Management and Counseling
Primary Outcome Measure Information:
Title
Treatment retention
Time Frame
52 weeks
Title
Reductions in illicit opioid use
Time Frame
52 weeks
Title
Adherence to antiretroviral medications
Time Frame
52 weeks
Secondary Outcome Measure Information:
Title
T-lymphocyte CD4 cell count
Time Frame
52 weeks
Title
HIV-1 RNA levels
Time Frame
52 weeks
Title
Reduction in HIV transmission risk behaviors
Time Frame
52 weeks
Title
Improved health status
Time Frame
52 weeks
Title
Patient satisfaction
Time Frame
52 weeks
Title
Provider satisfaction
Time Frame
52 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Christopher J Cutter, Ph.D.
Organizational Affiliation
Yale University
Official's Role
Study Director
Facility Information:
Facility Name
Yale University School of Medicine
City
New Haven
State/Province
Connecticut
ZIP/Postal Code
06519
Country
United States

12. IPD Sharing Statement

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Buprenorphine and Integrated HIV Care

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