AIDS, Drug Addiction, HIV Infections, Human Immunodeficiency Virus, Substance-related Disorders
Conditions
Keywords
Drug Abuse, Drug Addiction, Drug Dependence, Drug Use Disorders, Drug Use Disorder, Substance Abuse, Substance Use Disorder, Buprenorphine, Opiate Addiction
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.
Interventions
OTHERPhysician Management
Standard physician care
BEHAVIORALCounseling
Physician Management and Counseling
Sponsors
The New York Academy of Medicine
Yale University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Treatment retention | 52 weeks |
| Reductions in illicit opioid use | 52 weeks |
| Adherence to antiretroviral medications | 52 weeks |
Secondary
| Measure | Time frame |
|---|---|
| Improved health status | 52 weeks |
| T-lymphocyte CD4 cell count | 52 weeks |
| Provider satisfaction | 52 weeks |
| Patient satisfaction | 52 weeks |
| HIV-1 RNA levels | 52 weeks |
| Reduction in HIV transmission risk behaviors | 52 weeks |
Countries
United States
Outcome results
None listed