Buprenorphine to Improve HIV Care Engagement and Outcomes

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

281 participants

Study Classification

INTERVENTIONAL

Study Start Date

2015-07-31

Study Completion Date

2019-04-30

Brief Summary

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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.

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Detailed Description

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Conditions

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HIV Substance Related Disorders

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Buprenorphine/naloxone

Office based treatment of opioid dependence with buprenorphine/naloxone

Group Type EXPERIMENTAL

Buprenorphine/naloxone

Intervention Type DRUG

Buprenorphine/naloxone induction begins with a 2-4mg test dose followed by additional doses on the day of induction to relieve withdrawal symptoms, and then titrated to a maintenance dose between 8-24 mg/day over 1 to 3 days. Doses will be directly observed and occur daily. After a minimum of 2 weeks, dosing may be changed to 3 or 4 times per week, as determined clinically appropriate by the HIV clinic study physician. Dosing will remain flexible to a maximum dose of 24mg for daily dosing and 32mg for every other day dosing, as deemed clinically appropriate by the study physician.

Methadone Maintenance Therapy

Referral to methadone maintenance therapy for treatment of opioid dependence.

Group Type ACTIVE_COMPARATOR

Methadone Maintenance Therapy

Intervention Type DRUG

Subjects randomized to methadone maintenance therapy (MMT) referral will meet with an HIV clinic case manager who will facilitate referral to MMT. Methadone dosing will be managed by MMT staff, who dispense methadone according to Ministry of Health guidelines for MMT.

Interventions

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Buprenorphine/naloxone

Buprenorphine/naloxone induction begins with a 2-4mg test dose followed by additional doses on the day of induction to relieve withdrawal symptoms, and then titrated to a maintenance dose between 8-24 mg/day over 1 to 3 days. Doses will be directly observed and occur daily. After a minimum of 2 weeks, dosing may be changed to 3 or 4 times per week, as determined clinically appropriate by the HIV clinic study physician. Dosing will remain flexible to a maximum dose of 24mg for daily dosing and 32mg for every other day dosing, as deemed clinically appropriate by the study physician.

Intervention Type DRUG

Methadone Maintenance Therapy

Subjects randomized to methadone maintenance therapy (MMT) referral will meet with an HIV clinic case manager who will facilitate referral to MMT. Methadone dosing will be managed by MMT staff, who dispense methadone according to Ministry of Health guidelines for MMT.

Intervention Type DRUG

Other Intervention Names

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Suboxone

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No