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Buprenorphine and Integrated HIV Care
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Purpose
| Condition | Intervention | Phase |
|---|---|---|
| Substance-related Disorders Drug Addiction Human Immunodeficiency Virus AIDS HIV Infections | Other: Physician Management Behavioral: Counseling | Phase 4 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Treatment |
| Official Title: | On-Site Addiction Treatment With Buprenorphine in HIV Clinical Care Settings |
- Treatment retention [ Time Frame: 52 weeks ]
- Reductions in illicit opioid use [ Time Frame: 52 weeks ]
- Adherence to antiretroviral medications [ Time Frame: 52 weeks ]
- T-lymphocyte CD4 cell count [ Time Frame: 52 weeks ]
- HIV-1 RNA levels [ Time Frame: 52 weeks ]
- Reduction in HIV transmission risk behaviors [ Time Frame: 52 weeks ]
- Improved health status [ Time Frame: 52 weeks ]
- Patient satisfaction [ Time Frame: 52 weeks ]
- Provider satisfaction [ Time Frame: 52 weeks ]
| Enrollment: | 52 |
| Study Start Date: | September 2005 |
| Study Completion Date: | October 2012 |
| Primary Completion Date: | October 2009 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
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
|
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| Ages Eligible for Study: | 18 Years and older (Adult, Senior) |
| Sexes Eligible for Study: | All |
| Accepts 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.
Contacts and LocationsPlease refer to this study by its ClinicalTrials.gov identifier: NCT00317460
| United States, Connecticut | |
| Yale University School of Medicine | |
| New Haven, Connecticut, United States, 06519 | |
| Study Director: | Christopher J Cutter, Ph.D. | Yale University |
More Information
| Responsible Party: | Lynn E. Fiellin, Associate Professor, Yale University |
| ClinicalTrials.gov Identifier: | NCT00317460 History of Changes |
| Other Study ID Numbers: |
LS05NSC HIC 0510000681 |
| Study First Received: | April 20, 2006 |
| Last Updated: | July 8, 2014 |
Keywords provided by Lynn E. Fiellin, Yale University:
|
Drug Abuse Drug Addiction Drug Dependence Drug Use Disorders Drug Use Disorder |
Substance Abuse Substance Use Disorder Buprenorphine Opiate Addiction |
Additional relevant MeSH terms:
|
HIV Infections Immunologic Deficiency Syndromes Acquired Immunodeficiency Syndrome Behavior, Addictive Substance-Related Disorders Lentivirus Infections Retroviridae Infections RNA Virus Infections Virus Diseases Sexually Transmitted Diseases, Viral Sexually Transmitted Diseases Immune System Diseases Slow Virus Diseases |
Compulsive Behavior Impulsive Behavior Chemically-Induced Disorders Mental Disorders Buprenorphine Analgesics, Opioid Narcotics Central Nervous System Depressants Physiological Effects of Drugs Analgesics Sensory System Agents Peripheral Nervous System Agents Narcotic Antagonists |
ClinicalTrials.gov processed this record on July 25, 2017