Recruiting

Buprenorphine

Sponsor:

Organization to Achieve Solutions in Substance Abuse (OASIS)

Code:

NCT00241930

Conditions

Opiate Dependence

HIV Infections

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Not accepted

Interventions

Integrating drug treatment into HIV services

Study Details

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.

Conditions

Opiate Dependence

HIV Infections

Study ID

NCT00241930

Start date

Sep, 2005

Status verified date

Aug, 2005

Completion date

Feb, 2009

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Not accepted

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

Study Design

Enrollment

60 participants

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Interventions

Integrating drug treatment into HIV services

Primary outcome measure

  • 1.Impact of integrated care vs nonintegrated care on: [ Time Frame: undefined ]
  • a. Substance use and high-risk transmission behaviors [ Time Frame: undefined ]
  • b. Medical engagement and outcomes [ Time Frame: undefined ]
  • c. Psychosocial indices, such as criminal justice, employment, housing, and education [ Time Frame: undefined ]

Central Contacts and Locations

Central contacts

Diana L Sylvestre, MD

510-834-5442dsylves@itsa.ucsf.edu

Laphyne Barrett

510-834-5442oasisclinic@sbcglobal.net

Locations

Alameda County Medical Center HIV Clinic

Recruiting

Oakland, California, United States, 94602

Contacts

Lance Smith

510-437-4888

Silver Sisneros, MD

510-437-4891ssisneros@acmedctr.org

Principal Investigator:

Silver Sisneros, DO

OASIS

Recruiting

Oakland, California, United States, 94612

Contacts

Laphyne Barrett

510-834-5442oasisclinic@sbcglobal.net

Principal Investigator:

Diana L Sylvestre, MD

Fairmont Hospital HIV Clinic

Recruiting

San Leandro, California, United States, 94578

Contacts

Lance Smith

510-437-4888

Beth Schweitzer, MD

510-667-3201

Principal Investigator:

Beth Schweitzer, MD

More Information

Sponsor

Organization to Achieve Solutions in Substance Abuse (OASIS)

Last update posted

Oct 25, 2005

Last verified

Aug, 2005

Keywords

  • Heroin
  • HIV
  • buprenorphine
  • integration
  • drug treatment

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Organization to Achieve Solutions in Substance Abuse (OASIS) on 2005-10-25.