Buprenorphine and Integrated HIV Care - Full Text View

Purpose

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.

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 Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Treatment
Official Title:	On-Site Addiction Treatment With Buprenorphine in HIV Clinical Care Settings

Resource links provided by NLM:

MedlinePlus related topics: HIV/AIDS

Drug Information available for: Buprenorphine Buprenorphine hydrochloride

U.S. FDA Resources

Further study details as provided by Yale University:

Primary Outcome Measures:

Treatment retention [ Time Frame: 52 weeks ] [ Designated as safety issue: No ]
Reductions in illicit opioid use [ Time Frame: 52 weeks ] [ Designated as safety issue: No ]
Adherence to antiretroviral medications [ Time Frame: 52 weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

T-lymphocyte CD4 cell count [ Time Frame: 52 weeks ] [ Designated as safety issue: No ]
HIV-1 RNA levels [ Time Frame: 52 weeks ] [ Designated as safety issue: No ]
Reduction in HIV transmission risk behaviors [ Time Frame: 52 weeks ] [ Designated as safety issue: No ]
Improved health status [ Time Frame: 52 weeks ] [ Designated as safety issue: No ]
Patient satisfaction [ Time Frame: 52 weeks ] [ Designated as safety issue: No ]
Provider satisfaction [ Time Frame: 52 weeks ] [ Designated as safety issue: No ]


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)
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

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.

Contacts and Locations

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00317460

Locations


United States, Connecticut
Yale University School of Medicine
New Haven, Connecticut, United States, 06519

Sponsors and Collaborators

Yale University

The New York Academy of Medicine

Investigators


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
Health Authority:	United States: Institutional Review Board

Keywords provided by 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 September 29, 2016