HIV, Buprenorphine, and the Criminal Justice System (STRIDE)

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.

Study Overview

• Status: Completed
• Conditions: Acquired Immunodeficiency Syndrome; Human Immunodeficiency Virus; Opiate Addiction; Drug Dependence
• Intervention / Treatment: Drug: Buprenorphine/naloxone; Drug: Placebo Oral Tablet

Detailed 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.

• Study Type: Interventional
• Enrollment (Actual): 50
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • District of Columbia
    • Washington, District of Columbia, United States, 20060
      • Howard University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: NON_RANDOMIZED
• Interventional Model: PARALLEL
• Masking: NONE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Placebo Comparator: Placebo	Drug: Placebo Oral Tablet; 2/0.5, 8/2 sublingual tabs; dosage based on medical assessment; medications taken once per day for 12 months duration.
Active Comparator: Buprenorphine	Drug: Buprenorphine/naloxone; 2/0.5, 8/2 sublingual tabs; dosage based on medical assessment; medications taken once per day for 12 months duration.; Other Names: Suboxone

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
CD4 Count Absolute	CD4 Count Absolute	Baseline
CD4 Count Absolute	CD4 Count Absolute	6 Months
CD4 Count Absolute	CD4 Count	12 Months
CD4 Percent	CD4 Percent	Baseline
CD4 Percent	CD4 Percent	6 Months
CD4 Percent	CD4 Percent	12 Months
Viral Load	Viral Load	Baseline
Viral Load	Viral Load	6 Months
Viral Load	Viral Load	12 Months
Log Viral Load	Log Viral Load	Baseline
Log Viral Load	Log Viral Load	6 Months
Log Viral Load	Log Viral Load	12 Months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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

Collaborators and Investigators

• Sponsor: Yale University
• Collaborators: National Institute on Drug Abuse (NIDA); Howard University; George Mason University
• Investigators: Principal Investigator: Frederick Altice, MD, Yale University School of Medicine/AIDS Program

Study record dates

Study Major Dates

• Study Start (Actual): February 23, 2012
• Primary Completion (Actual): November 30, 2015
• Study Completion (Actual): November 30, 2016

Study Registration Dates

• First Submitted: June 21, 2011
• First Submitted That Met QC Criteria: March 6, 2012
• First Posted (Estimate): March 12, 2012

Study Record Updates

• Last Update Posted (Actual): May 6, 2020
• Last Update Submitted That Met QC Criteria: April 27, 2020
• Last Verified: April 1, 2020

More Information

Terms related to this study

• Keywords: HIV; AIDS; Buprenorphine; Opiate Addiction; Drug Dependence
• Additional Relevant MeSH Terms: Mental Disorders; Chemically-Induced Disorders; RNA Virus Infections; Virus Diseases; Infections; Blood-Borne Infections; Communicable Diseases; Sexually Transmitted Diseases, Viral; Sexually Transmitted Diseases; Lentivirus Infections; Retroviridae Infections; Immune System Diseases; Slow Virus Diseases; Narcotic-Related Disorders; Compulsive Behavior; Impulsive Behavior; Substance-Related Disorders; HIV Infections; Acquired Immunodeficiency Syndrome; Immunologic Deficiency Syndromes; Opioid-Related Disorders; Behavior, Addictive; Physiological Effects of Drugs; Central Nervous System Depressants; Peripheral Nervous System Agents; Analgesics; Sensory System Agents; Analgesics, Opioid; Narcotics; Narcotic Antagonists; Buprenorphine; Naloxone; Buprenorphine, Naloxone Drug Combination
• Other Study ID Numbers: 1011007631; R01DA030768 (U.S. NIH Grant/Contract)