Clinical trial NCT00317460: Buprenorphine and Integrated HIV Care
Official title: On-Site Addiction Treatment With Buprenorphine in HIV Clinical Care Settings
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: 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
Lead sponsor: Yale University
Sponsor class: OTHER
Collaborators: name: The New York Academy of Medicine
First posted: 2006-04-24
Enrollment: 52
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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.

Primary outcomes:
measure: Treatment retention
timeFrame: 52 weeks
measure: Reductions in illicit opioid use
timeFrame: 52 weeks
measure: Adherence to antiretroviral medications
timeFrame: 52 weeks
Secondary outcomes:
measure: T-lymphocyte CD4 cell count
timeFrame: 52 weeks
measure: HIV-1 RNA levels
timeFrame: 52 weeks
measure: Reduction in HIV transmission risk behaviors
timeFrame: 52 weeks
measure: Improved health status
timeFrame: 52 weeks
measure: Patient satisfaction
timeFrame: 52 weeks
measure: Provider satisfaction
timeFrame: 52 weeks
Other outcomes:
Locations:
city: New Haven
country: United States
facility: Yale University School of Medicine
state: Connecticut
Study officials:
affiliation: Yale University
name: Christopher J Cutter, Ph.D.
role: STUDY_DIRECTOR
References: