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

April 20, 2006
July 8, 2014
September 2005
October 2009   (final data collection date for primary outcome measure)
  • 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 ]
  • Treatment retention
  • Reductions in illicit opioid use
  • Adherence to antiretroviral medications
Complete list of historical versions of study NCT00317460 on ClinicalTrials.gov Archive Site
  • 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 ]
  • T-lymphocyte CD4 cell count
  • HIV-1 RNA levels
  • Reduction in HIV transmission risk behaviors
  • Improved health status
  • Patient satisfaction
  • Provider satisfaction
Not Provided
Not Provided
 
Buprenorphine and Integrated HIV Care
On-Site Addiction Treatment With Buprenorphine in HIV Clinical Care Settings

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 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.

Interventional
Phase 4
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
  • Substance-related Disorders
  • Drug Addiction
  • Human Immunodeficiency Virus
  • AIDS
  • HIV Infections
  • Other: Physician Management
    Standard physician care
  • Behavioral: Counseling
    Physician Management and Counseling
  • Active Comparator: 1
    Physician Management
    Intervention: Other: Physician Management
  • Experimental: 2
    Physician Management and counseling (drug counseling and medication adherence)
    Intervention: Behavioral: Counseling
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
52
October 2012
October 2009   (final data collection date for primary outcome measure)

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.
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00317460
LS05NSC, HIC 0510000681
No
Lynn E. Fiellin, Yale University
Yale University
The New York Academy of Medicine
Study Director: Christopher J Cutter, Ph.D. Yale University
Yale University
July 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP