Integrating Buprenorphine Into HIV Treatment

Tracking Information
First Submitted Date ICMJE	October 17, 2005
First Posted Date ICMJE	October 19, 2005
Last Update Posted Date	October 25, 2005
Study Start Date ICMJE	September 2005
Primary Completion Date	Not Provided
Current Primary Outcome Measures ICMJE; (submitted: October 17, 2005)	1.Impact of integrated care vs nonintegrated care on:; a. Substance use and high-risk transmission behaviors; b. Medical engagement and outcomes; c. Psychosocial indices, such as criminal justice, employment, housing, and education
Original Primary Outcome Measures ICMJE	Same as current
Change History	Complete list of historical versions of study NCT00241930 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures ICMJE; (submitted: October 17, 2005)	1. Acceptability of HIV treatment-based buprenorphine therapy; 2. Health services utilization
Original Secondary Outcome Measures ICMJE	Same as current
Current Other Outcome Measures ICMJE	Not Provided
Original Other Outcome Measures ICMJE	Not Provided
Descriptive Information
Brief Title ICMJE	Integrating Buprenorphine Into HIV Treatment
Official Title ICMJE	SPNS Buprenorphine and Integrated HIV Care Evaluation and Support Center: Integration of Buprenorphine and HIV Treatment Using the OASIS Model
Brief Summary	We hypothesize that integrating drug treatment into HIV treatment will improve HIV outcomes as well as drug treatment outcomes in heroin users. This study will test this hypothesis by randomizing patients to two groups. The first group will receive HIV treatment and buprenorphine treatment contemporaneously at their HIV clinic. The second group will receive HIV treatment at their HIV clinic, and go to another facility to receive buprenorphine treatment services. We will look at HIV outcomes such as CD4 counts, HIV viral loads, and attendance at appointments and drug treatment outcomes such as receipt of buprenorphine and urine toxicology testing.
Detailed Description	This study will test the hypothesis that integrating buprenorphine within the context of primary care HIV treatment will improve outcomes for HIV-infected heroin users vs providing buprenorphine services at a separate, off-site facility. As a means of engagement, we will offer the OASIS education group each week at each facility. For those randomized to integrated care, subjects will attend one education session weekly at the time of their HIV clinic. During these sessions, subjects will receive contemporaneous HIV clinic appointments (monthly), case management (monthly), drug counseling (twice monthly), and buprenorphine (which will be dispensed weekly.) For those randomized to separate care, subjects will attend HIV clinic appointments monthly, and will attend weekly education sessions at the OASIS facility. During these sessions, subjects will receive weekly buprenorphine, twice monthly drug counseling, and monthly case management. We will measure outcomes by reporting attendance, CD4 counts, HIV viral loads, urine toxicology testing on at least a quarterly basis. We will also measure patient satisfaction, knowledge, quality of life, and a number of other outcomes.
Study Type ICMJE	Interventional
Study Phase	Phase 4
Study Design ICMJE	Allocation: Randomized; Intervention Model: Parallel Assignment; Masking: None (Open Label); Primary Purpose: Treatment
Condition ICMJE	Opiate Dependence; HIV Infections
Intervention ICMJE	Behavioral: Integrating drug treatment into HIV services
Study Arms	Not Provided
Publications *	Not Provided
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
Recruitment Information
Recruitment Status ICMJE	Unknown status
Enrollment ICMJE; (submitted: October 17, 2005)	60
Original Enrollment ICMJE	Same as current
Study Completion Date	February 2009
Primary Completion Date	Not Provided
Eligibility Criteria ICMJE	Inclusion Criteria: HIV+ as verified by lab report; DSM-IV diagnosis of opioid dependence; Speaks/understands English; Age 18 years or older Exclusion Criteria: LFT's (transaminase) >5x ULN; DSV-IV criteria for benzodiazepine abuse or dependence within the last month; DSM-IV criteria for alcohol dependence within the past 6 months; Actively suicidal; Methadone dose exceeds level allowing safe transition to buprenorphine; Pregnant women and women trying to become pregnant; Unable to provide informed consent; Clinical judgement that patient is inappropriate
Sex/Gender	Sexes Eligible for Study: All
Ages	18 Years to 85 Years (Adult, Senior)
Accepts Healthy Volunteers	No
Contacts ICMJE	Contact information is only displayed when the study is recruiting subjects
Listed Location Countries ICMJE	United States
Removed Location Countries
Administrative Information
NCT Number ICMJE	NCT00241930
Other Study ID Numbers ICMJE	H97HA03792; 1 H97HA03792-01-00
Has Data Monitoring Committee	Not Provided
U.S. FDA-regulated Product	Not Provided
IPD Sharing Statement	Not Provided
Responsible Party	Not Provided
Study Sponsor ICMJE	Organization to Achieve Solutions in Substance Abuse (OASIS)
Collaborators ICMJE	Not Provided
Investigators ICMJE	Principal Investigator: Diana L Sylvestre, MD Organization to Achieve Solutions in Substance Abuse (OASIS) Study Director: Ruth Finkelstein, ScD New York Academy of Medicine
PRS Account	Organization to Achieve Solutions in Substance Abuse (OASIS)
Verification Date	August 2005
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP