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Integrated Harm Reduction for Substance Use Disorders (HRS Trial)
N/A
Waitlist Available
Led By Ayana Jordan, MD, PhD
Research Sponsored by NYU Langone Health
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to week 8
Awards & highlights
HRS Trial Summary
This trial will compare two approaches to help Black & Latinx PWUD reduce drug-related harm: an IHRI & regular HR services.
Who is the study for?
This trial is for English or Spanish-speaking adults who self-identify as misusing opioids and/or other substances, confirmed by an interview. It's specifically aimed at Black and Latinx individuals. People with severe mental health disorders, active suicidal or homicidal thoughts, prisoners, or those unable to consent are not eligible.Check my eligibility
What is being tested?
The study is testing whether a specific program called Integrated Harm Reduction Intervention (IHRI) can improve service utilization among people who use drugs compared to the usual harm reduction services offered.See study design
What are the potential side effects?
Since this trial involves harm reduction services rather than medication, traditional side effects are not applicable. However, participants may experience emotional discomfort when discussing substance use.
HRS Trial Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ up to week 8
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to week 8
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Percentage of Participants who Attend At least 1 Harm Reduction (HR) Session after Introductory HR Session
Percentage of Participants who Attend at least 3 HR Sessions in Total
Secondary outcome measures
Change from Baseline in Brief Quality of Life Scale Score
Change from Baseline in Number of Days of Opioid/Other Stimulant Use
Change from Baseline in Overdose Risk Assessment Tool Score
HRS Trial Design
2Treatment groups
Experimental Treatment
Active Control
Group I: IHRIExperimental Treatment1 Intervention
Integrated harm reduction intervention (IHRI) program tailored specifically for highly marginalized Black and Latinx people who use drugs (PWUDs). The IHRI lasts 8 weeks in duration, with the first 4 weeks consisting of weekly education lessons provided by the IHRI care coordinator. The subsequent 4 weeks will involve individualized identification of vulnerabilities in the social determinants of health (SDOH) for the purposes of making informed referrals to relevant partnering social service organizations. Participants will also be exposed to service encounters through mobile vans in which staff offer information to PWUD on syringe exchange, clean user kits, naloxone use, and fentanyl strip distribution.
Group II: HR SAUActive Control1 Intervention
Harm reduction services as usual (HR SAU). Participants will be exposed to service encounters through the mobile vans in which staff offer information to PWUD on syringe exchange, clean user kits, naloxone use, and fentanyl strip distribution.
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Who is running the clinical trial?
NYU Langone HealthLead Sponsor
1,367 Previous Clinical Trials
839,561 Total Patients Enrolled
1 Trials studying Substance Use
350 Patients Enrolled for Substance Use
National Institute of General Medical Sciences (NIGMS)NIH
268 Previous Clinical Trials
248,560 Total Patients Enrolled
2 Trials studying Substance Use
284 Patients Enrolled for Substance Use
Ayana Jordan, MD, PhDPrincipal InvestigatorNYU Langone Health
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Eligibility Criteria:
This trial includes the following eligibility criteria:- I do not have thoughts of harming myself or others and do not suffer from severe mental health disorders.I am able to understand and agree to the study's procedures.I am 18 years old or older.I speak English or Spanish.I am not open to being randomly assigned to a treatment group.
Research Study Groups:
This trial has the following groups:- Group 1: IHRI
- Group 2: HR SAU
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Is enrollment for this experiment still open?
"Per the information posted on clinicaltrials.gov, this study is no longer recruiting participants as of March 6th 2023; its initial posting date was April 1st 2023. However, there are 716 other trials in progress currently seeking volunteers."
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Who else is applying?
What site did they apply to?
NYU Langone Health
What portion of applicants met pre-screening criteria?
Met criteria
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