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Buprenorphine to Improve HIV Care Engagement and Outcomes (BRAVO)

Oregon Health & Science University (OHSU) logo

Oregon Health & Science University (OHSU)

Status and phase

Completed
Phase 4

Conditions

HIV
Substance Related Disorders

Treatments

Drug: Buprenorphine/naloxone
Drug: Methadone Maintenance Therapy

Study type

Interventional

Funder types

Other

Identifiers

NCT01936857
1R01DA037441_VNE
1R01DA037441 (U.S. NIH Grant/Contract)

Details and patient eligibility

About

The purpose of this study is to compare two models of substance abuse treatment in Vietnam, and how they each affect HIV care. In Vietnam, the current model for treating people with HIV who are also dependent on opioids is to refer them to methadone maintenance treatment centers. The new model the protocol will study is treatment of HIV and opioid dependence with buprenorphine/naloxone and counseling in the HIV clinic.

Enrollment

281 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

Inclusion criteria

  • HIV positive
  • Current moderate or severe Diagnostic and Statistical Manual (DSM-V) opioid use disorder
  • Urine drug screen positive for opioids
  • Interested in receiving treatment for opioid dependence
  • Age at least 18 years old
  • Willing to practice an effective method of birth control, if female

Exclusion criteria

  • Known hypersensitivity to buprenorphine or naloxone
  • aspartate aminotransferase (AST) & alanine aminotransferase (ALT) > 5x upper limit
  • Currently pregnant or breastfeeding
  • Serious medical or psychiatric illness in past 30 days (e.g. opportunistic infection, psychosis) that precludes safe participation in the opinion of study physician
  • Methadone maintenance treatment within 30 days of consent

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

None (Open label)

281 participants in 2 patient groups

Buprenorphine/naloxone
Experimental group
Description:
Office based treatment of opioid dependence with buprenorphine/naloxone
Treatment:
Drug: Buprenorphine/naloxone
Methadone Maintenance Therapy
Active Comparator group
Description:
Referral to methadone maintenance therapy for treatment of opioid dependence.
Treatment:
Drug: Methadone Maintenance Therapy

Trial documents
1

Trial contacts and locations

6

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Data sourced from clinicaltrials.gov

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