Buprenorphine and Integrated HIV Care

This study has been completed.
Sponsor:
Collaborator:
The New York Academy of Medicine
Information provided by (Responsible Party):
Lynn E. Fiellin, Yale University
ClinicalTrials.gov Identifier:
NCT00317460
First received: April 20, 2006
Last updated: July 8, 2014
Last verified: July 2014
  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:


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
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

Additional Information:
No publications provided

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:
Acquired Immunodeficiency Syndrome
HIV Infections
Immunologic Deficiency Syndromes
Substance-Related Disorders
Behavior, Addictive
Lentivirus Infections
Retroviridae Infections
RNA Virus Infections
Virus Diseases
Sexually Transmitted Diseases, Viral
Sexually Transmitted Diseases
Slow Virus Diseases
Immune System Diseases
Mental Disorders
Compulsive Behavior
Impulsive Behavior
Buprenorphine
Analgesics, Opioid
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Pharmacologic Actions
Central Nervous System Agents
Therapeutic Uses
Central Nervous System Depressants
Narcotic Antagonists
Narcotics

ClinicalTrials.gov processed this record on July 28, 2014