HIV, Buprenorphine, and the Criminal Justice System

Human Immunodeficiency Virus Clinical Trial

— STRIDE  

Official title:

HIV, Buprenorphine, and the Criminal Justice System

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01550341
• Other study ID #: 1011007631
• Secondary ID: R01DA030768
• Status: Completed
• Phase: N/A
• Start date: February 23, 2012
• Est. completion date: November 30, 2016

Study information

• Verified date: April 2020
• Source: Yale University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The aims of STRIDE were changed as of July, 2014. The revised project, called STRIDE2, has a longitudinal, non-randomized, observational study design. The population under study consists of individuals living with HIV who are dependent on opioids.

Description:

Presented in the results section are the summary of outcomes from the STRIDE RCT that were collected prior to the change in study design. The STRIDE study became STRIDE2 (NCT03583138). Those individuals originally enrolled in the STRIDE RCT will be followed for 12 months.

STRIDE2 will assist in identifying and monitoring individuals' HIV risk behaviors and provide resources to seek treatment for their HIV care and substance use. The goal of STRIDE2 is to examine if there are differences in HIV, drug use, and other outcomes between individuals receiving treatment versus individuals actively using, not actively using and not in treatment, and individuals on Methadone, Suboxone, or in some other treatment.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 50
• Est. completion date: November 30, 2016
• Est. primary completion date: November 30, 2015
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• HIV+

• Age =18 yrs

• Meets DSM-IV criteria for opioid dependence

• Has medical entitlements in DC

• Able to provide informed consent

• Able to communicate in English or Spanish

Exclusion Criteria:

• Being prescribed an opiate medication for a chronic pain condition or expressing the need to be placed on chronic pain medical conditions for a documented pain condition

• Currently receiving methadone dosing of over 30 mg per day and uninterested in changing to buprenorphine

• AST and ALT >5x the upper limit of normal (AST=175, ALT=195)

• Pregnant or unwilling to use contraception (including OCPs, patch, Depo-Provera, condoms, etc.)

• Breastfeeding or unwilling to stop breastfeeding

• Subject is part of another pharmacological research study

• Liver dysfunction (acute hepatitis, liver failure or hepatic dysfunction)

• Suicidal ideation

• Hypersensitivity to buprenorphine

Related Conditions & MeSH terms

• Acquired Immunodeficiency Syndrome
• Behavior, Addictive
• Drug Dependence
• HIV Infections
• Human Immunodeficiency Virus
• Immunologic Deficiency Syndromes
• Opiate Addiction
• Opioid-Related Disorders
• Substance-Related Disorders

Intervention

Drug:
• Buprenorphine/naloxone
2/0.5, 8/2 sublingual tabs; dosage based on medical assessment; medications taken once per day for 12 months duration.
• Placebo Oral Tablet
2/0.5, 8/2 sublingual tabs; dosage based on medical assessment; medications taken once per day for 12 months duration.

Locations

Country	Name	City	State
United States	Howard University	Washington	District of Columbia

Sponsors (4)

Lead Sponsor	Collaborator
Yale University	George Mason University, Howard University, National Institute on Drug Abuse (NIDA)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	CD4 Count Absolute	CD4 Count Absolute	Baseline
Primary	CD4 Count Absolute	CD4 Count Absolute	6 Months
Primary	CD4 Count Absolute	CD4 Count	12 Months
Primary	CD4 Percent	CD4 Percent	Baseline
Primary	CD4 Percent	CD4 Percent	6 Months
Primary	CD4 Percent	CD4 Percent	12 Months
Primary	Viral Load	Viral Load	Baseline
Primary	Viral Load	Viral Load	6 Months
Primary	Viral Load	Viral Load	12 Months
Primary	Log Viral Load	Log Viral Load	Baseline
Primary	Log Viral Load	Log Viral Load	6 Months
Primary	Log Viral Load	Log Viral Load	12 Months
Secondary	Improved Opioid Treatment Outcomes	Monitor relapse to opioid use, retention on Buprenorphine or placebo, percent days using opioids, lower addiction severity, lower craving, between baseline and subsequent follow-up visits. Monitor urine toxicology screens on every visit for approximately one year.	baseline, 3 months, 9 months, 12 months
Secondary	Improved Criminal Justice Outcomes	Measure change in time to reincarceration,number of days reincarcerated, and crime days, between baseline and each monthly follow-up visit.	baseline, wk 4, 9, 13, 18, 22, 27, 31, 36, 40, 45, 49, 52