Buprenorphine and Integrated HIV Care

NCT ID: NCT00317460

Last Updated: 2020-04-03

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE4
• Total Enrollment: 52 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2005-09-30
• Study Completion Date: 2012-10-31

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.

Conditions

Substance-related Disorders; Drug Addiction; Human Immunodeficiency Virus; AIDS; HIV Infections

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

1

Physician Management

Group Type: ACTIVE_COMPARATOR

Physician Management

Intervention Type: OTHER

Standard physician care

2

Physician Management and counseling (drug counseling and medication adherence)

Group Type: EXPERIMENTAL

Counseling

Intervention Type: BEHAVIORAL

Physician Management and Counseling

Interventions

Physician Management

Standard physician care

Intervention Type: OTHER

Counseling

Physician Management and Counseling

Intervention Type: BEHAVIORAL

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

The New York Academy of Medicine

OTHER

Sponsor Role: collaborator

Yale University

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Christopher J Cutter, Ph.D.

Role: STUDY_DIRECTOR

Yale University

Locations

Yale University School of Medicine

New Haven, Connecticut, United States

Countries

United States

Other Identifiers

0510000681

Identifier Type: -

Identifier Source: org_study_id