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Integrating Buprenorphine Into HIV Treatment

O

Organization to Achieve Solutions in Substance Abuse (OASIS)

Status and phase

Unknown
Phase 4

Conditions

Opiate Dependence
HIV Infections

Treatments

Behavioral: Integrating drug treatment into HIV services

Study type

Interventional

Funder types

Other

Identifiers

NCT00241930
H97HA03792
1 H97HA03792-01-00

Details and patient eligibility

About

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.

Full 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.

Sex

All

Ages

18 to 85 years old

Volunteers

No Healthy Volunteers

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

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

None (Open label)

Trial contacts and locations

3

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Central trial contact

Laphyne Barrett; Diana L Sylvestre, MD

Data sourced from clinicaltrials.gov

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