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Buprenorphine and Integrated HIV Care

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ClinicalTrials.gov Identifier: NCT00317460
Recruitment Status : Completed
First Posted : April 24, 2006
Last Update Posted : July 9, 2014
Sponsor:
Collaborator:
The New York Academy of Medicine
Information provided by (Responsible Party):
Lynn E. Fiellin, Yale University

Study Description
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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information
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.

Condition or disease Intervention/treatment Phase
Substance-related Disorders Drug Addiction Human Immunodeficiency Virus AIDS HIV Infections Other: Physician Management Behavioral: Counseling Phase 4

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.


Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 52 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: On-Site Addiction Treatment With Buprenorphine in HIV Clinical Care Settings
Study Start Date : September 2005
Actual Primary Completion Date : October 2009
Actual Study Completion Date : October 2012

Resource links provided by the National Library of Medicine

MedlinePlus related topics: HIV/AIDS
U.S. FDA Resources

Arms and Interventions
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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Arm Intervention/treatment
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


Outcome Measures
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Primary Outcome Measures :
  1. Treatment retention [ Time Frame: 52 weeks ]
  2. Reductions in illicit opioid use [ Time Frame: 52 weeks ]
  3. Adherence to antiretroviral medications [ Time Frame: 52 weeks ]

Secondary Outcome Measures :
  1. T-lymphocyte CD4 cell count [ Time Frame: 52 weeks ]
  2. HIV-1 RNA levels [ Time Frame: 52 weeks ]
  3. Reduction in HIV transmission risk behaviors [ Time Frame: 52 weeks ]
  4. Improved health status [ Time Frame: 52 weeks ]
  5. Patient satisfaction [ Time Frame: 52 weeks ]
  6. Provider satisfaction [ Time Frame: 52 weeks ]

Eligibility Criteria
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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
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
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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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
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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations 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
First Posted: April 24, 2006    Key Record Dates
Last Update Posted: July 9, 2014
Last Verified: July 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