Buprenorphine and Integrated HIV Care
On-Site Addiction Treatment With Buprenorphine in HIV Clinical Care Settings
1 other identifier
interventional
52
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_4
Started Sep 2005
Longer than P75 for phase_4
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
September 1, 2005
CompletedFirst Submitted
Initial submission to the registry
April 20, 2006
CompletedFirst Posted
Study publicly available on registry
April 24, 2006
CompletedPrimary Completion
Last participant's last visit for primary outcome
October 1, 2009
CompletedStudy Completion
Last participant's last visit for all outcomes
October 1, 2012
CompletedApril 3, 2020
April 1, 2020
4.1 years
April 20, 2006
April 1, 2020
Conditions
Keywords
Outcome Measures
Primary Outcomes (3)
Treatment retention
52 weeks
Reductions in illicit opioid use
52 weeks
Adherence to antiretroviral medications
52 weeks
Secondary Outcomes (6)
T-lymphocyte CD4 cell count
52 weeks
HIV-1 RNA levels
52 weeks
Reduction in HIV transmission risk behaviors
52 weeks
Improved health status
52 weeks
Patient satisfaction
52 weeks
- +1 more secondary outcomes
Study Arms (2)
1
ACTIVE COMPARATORPhysician Management
2
EXPERIMENTALPhysician Management and counseling (drug counseling and medication adherence)
Interventions
Eligibility Criteria
You may qualify if:
- HIV disease
- DSM-IV criteria for opioid dependence, as assessed by SCID
- Documented opioid positive urine toxicology testing
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Yale Universitylead
- The New York Academy of Medicinecollaborator
Study Sites (1)
Yale University School of Medicine
New Haven, Connecticut, 06519, United States
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Christopher J Cutter, Ph.D.
Yale University
Study Design
- Study Type
- interventional
- Phase
- phase 4
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
April 20, 2006
First Posted
April 24, 2006
Study Start
September 1, 2005
Primary Completion
October 1, 2009
Study Completion
October 1, 2012
Last Updated
April 3, 2020
Record last verified: 2020-04