Buprenorphine and Integrated HIV Care

Sponsor

Yale University (Other)

Overall Status

Completed

CT.gov ID

NCT00317460

Collaborator

The New York Academy of Medicine (Other)

Enrollment

Location

Arms

Duration (Months)

0.6

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

Condition or Disease	Intervention/Treatment	Phase
Substance-related Disorders Drug Addiction Human Immunodeficiency Virus AIDS HIV Infections	Other: Physician Management Behavioral: Counseling	Phase 4

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 Design

Study Type:

Interventional

Actual Enrollment :

52 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

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

Study Start Date :

Sep 1, 2005

Actual Primary Completion Date :

Oct 1, 2009

Actual Study Completion Date :

Oct 1, 2012

Arms and Interventions

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

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

Outcome Measures

Primary Outcome Measures

Treatment retention [52 weeks]
Reductions in illicit opioid use [52 weeks]
Adherence to antiretroviral medications [52 weeks]

Secondary Outcome Measures

T-lymphocyte CD4 cell count [52 weeks]
HIV-1 RNA levels [52 weeks]
Reduction in HIV transmission risk behaviors [52 weeks]
Improved health status [52 weeks]
Patient satisfaction [52 weeks]
Provider satisfaction [52 weeks]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts 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.