Buprenorphine and Integrated HIV Care

HIV Infections Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00317460
• Other study ID #: 0510000681
• Status: Completed
• Phase: Phase 4
• Start date: September 2005
• Est. completion date: October 2012

Study information

• Verified date: April 2020
• Source: Yale University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 52
• Est. completion date: October 2012
• Est. primary completion date: October 2009
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Acquired Immunodeficiency Syndrome
• AIDS
• Behavior, Addictive
• Drug Addiction
• HIV Infections
• Human Immunodeficiency Virus
• Substance-related Disorders

Intervention

Other:
• Physician Management
Standard physician care

Behavioral:
• Counseling
Physician Management and Counseling

Locations

Country	Name	City	State
United States	Yale University School of Medicine	New Haven	Connecticut

Sponsors (2)

Lead Sponsor	Collaborator
Yale University	The New York Academy of Medicine

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Treatment retention		52 weeks
Primary	Reductions in illicit opioid use		52 weeks
Primary	Adherence to antiretroviral medications		52 weeks
Secondary	T-lymphocyte CD4 cell count		52 weeks
Secondary	HIV-1 RNA levels		52 weeks
Secondary	Reduction in HIV transmission risk behaviors		52 weeks
Secondary	Improved health status		52 weeks
Secondary	Patient satisfaction		52 weeks
Secondary	Provider satisfaction		52 weeks