Integrated Harm Reduction for Substance Use Disorders

(HRS Trial)

Recruiting at 2 trial locations

Overseen By Ayana Jordan, MD, PhD

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: NYU Langone Health

Disqualifiers: Unstable psychotic, mood disorders, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: Unknown

Duration: 8 weeks

200 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to determine if the Integrated Harm Reduction Intervention (IHRI) program helps Black and Latinx individuals who use drugs access harm reduction services more effectively than usual services. The IHRI provides education, support, and connections to social services over eight weeks. Participants will also have access to mobile vans offering resources like clean user kits and naloxone, a medication that can reverse opioid overdoses. The trial seeks English or Spanish-speaking adults who have misused opioids, possibly along with other substances, in the past month. As an unphased trial, this study offers a unique opportunity to contribute to innovative harm reduction strategies.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications.

What prior data suggests that this integrated harm reduction intervention is safe?

Research has shown that the Integrated Harm Reduction Intervention (IHRI) is generally safe for participants. In a study of similar treatments for substance use problems, about 12% of participants experienced serious side effects, though these were not caused by the treatment itself. Additionally, harm reduction programs like IHRI have not been linked to negative effects on individuals or communities. This suggests that IHRI is well-tolerated and does not cause harm. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the Integrated Harm Reduction Intervention (IHRI) because it offers a tailored approach for highly marginalized Black and Latinx people who use drugs. Unlike standard harm reduction services, the IHRI combines education and personalized support to address social determinants of health. Over the course of eight weeks, participants receive weekly educational lessons and personalized referrals to social services, which is a more comprehensive approach than traditional methods. This integrated strategy aims to empower individuals by providing them with the knowledge and resources they need to make informed decisions about their health and well-being.

What evidence suggests that the Integrated Harm Reduction Intervention (IHRI) is effective for improving harm reduction service utilization among Black and Latinx people who use drugs?

Research has shown that harm reduction strategies can improve health for people who use drugs and help prevent diseases like HIV and Hepatitis C. This trial tests the Integrated Harm Reduction Intervention (IHRI), an adaptable program designed to meet the specific needs of Black and Latinx communities. The approach combines education and personalized support to connect people with useful services. While specific data on IHRI's effectiveness is limited, the harm reduction principles it employs are supported by strong evidence. These strategies are known to make drug use safer and improve health. ^{1 2 3 6 7}

Who Is on the Research Team?

Ayana Jordan, MD, PhD

Principal Investigator

NYU Langone Health

Are You a Good Fit for This Trial?

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.

Inclusion Criteria

Able to provide informed consent

Self-identified as misusing opioids +/- other substances (stimulants) in the past 30 days, confirmed by interview using DSM-5 criteria

Exclusion 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.

Prisoners

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive the Integrated Harm Reduction Intervention (IHRI) program tailored for Black and Latinx people who use drugs, lasting 8 weeks with weekly education lessons and individualized social service referrals.

8 weeks

Weekly visits (in-person or virtual)

Follow-up

Participants are monitored for engagement and changes in overdose risk and quality of life after the intervention

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Integrated Harm Reduction Intervention (IHRI)

Trial Overview

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.

How Is the Trial Designed?

Group I: IHRI Experimental Treatment 1 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 SAU Active Control 1 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.

Who Is Running the Clinical Trial?

NYU Langone Health

Lead Sponsor

Trials

1,431

Recruited

838,000+

National Institute of General Medical Sciences (NIGMS)

Collaborator

Trials

315

Recruited

251,000+

Published Research Related to This Trial

A new standardized strategy for reporting adverse events (AEs) and serious adverse events (SAEs) in substance use disorder (SUD) clinical trials was developed, which aims to reduce the reporting burden while maintaining safety monitoring.

In a review of 17 SUD trials involving 6737 participants, the new strategy showed a significant reduction in irrelevant safety event reporting, leading to a more consistent safety assessment system tailored to the risks associated with specific trial interventions.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Strategies for safety reporting in substance abuse trials. Lindblad, R., Campanella, M., Styers, D., et al.[2013]

A study of 1244 opioid-dependent individuals found that those who stopped naltrexone treatment experienced significantly higher overdose rates (39 overdoses per 100 person-years) compared to those who left agonist treatments, indicating a critical risk period immediately after stopping naltrexone.

Overall, individuals who left any pharmacotherapy for opioid dependence had much higher rates of serious adverse events and deaths (six per 100 person-years) compared to when they were in treatment, highlighting the need for ongoing support and risk education after treatment cessation.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Serious adverse events in the Australian National Evaluation of Pharmacotherapies for Opioid Dependence (NEPOD). Digiusto, E., Shakeshaft, A., Ritter, A., et al.[2022]

In a study involving 1,687 substance-abusing participants over 27,198 person-weeks, 12% experienced serious adverse events (SAEs), but none were deemed related to the psychosocial interventions being tested.

There were no significant differences in the incidence rates of SAEs between those receiving standard care and those receiving additional interventions like contingency management or motivational enhancement, suggesting that these psychosocial treatments are safe in terms of serious adverse events.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Serious adverse events in randomized psychosocial treatment studies: safety or arbitrary edicts? Petry, NM., Roll, JM., Rounsaville, BJ., et al.[2021]

A prototype electronic Global Trigger Tool was developed to improve the identification of adverse events in hospitals, addressing limitations of existing methods that rely on retroactive chart reviews.

Feedback from six health professionals highlighted the need for better tracking of adverse events and suggested features for a user-friendly interface, paving the way for integration into electronic health record systems to enhance patient safety.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Development and Usability Testing of a System to Detect Adverse Events and Medical Mistakes. Blakeney, EA., Dardas, T., Zierler, BK., et al.[2023]

Citations

1.

reporter.nih.gov

reporter.nih.gov/search/V1jUuzNg_Ua4xCfy2-_l5w/project-details/10590442

jordan, ayana - NIH RePORTER

To tackle these unique problems, we created an integrated harm reduction intervention (IHRI) to be mobile and flexible to the needs of Black and Latinx PWUD.

2.

clinicaltrials.gov

clinicaltrials.gov/study/NCT05776316

Study Details | NCT05776316 | Harm Reduction Services

The purpose of this study is to assess whether an integrated harm reduction intervention (IHRI), compared to harm reduction (HR) services as usual, will improve ...

3.

withpower.com

withpower.com/trial/phase-substance-related-disorders-3-2023-d5f9d

Integrated Harm Reduction for Substance Use Disorders

In a study of psychosocial treatments for substance use disorders, 12% of participants experienced serious adverse events, but none were related to the study ...

4.

harmreductionjournal.biomedcentral.com

harmreductionjournal.biomedcentral.com/articles/10.1186/s12954-025-01238-4

U.S. substance use harm reduction efforts: a review of the ...

SSPs are effective in reducing transmission of HIV and HCV, reducing injection drug use overall, and increasing the likelihood of individuals ...

5.

mattersnetwork.org

mattersnetwork.org/efficacy-of-harm-reduction/

Efficacy of Harm Reduction

Harm reduction strategies have repeatedly demonstrated their effectiveness in improving health outcomes for PWUD and mitigating broader public health risks.

6.

ihri.org

ihri.org/wp-content/uploads/2024/04/Annual-Report-2023-Final-1.pdf

Report

Drug Use and Harm Reduction. CLYMAX. 41. Study on the Impact of Cannabis. Decriminalization. 43. REFORM Project. 44. Other STIs. Optimizing Anal HSIL Screening ...

7.

psnet.ahrq.gov

psnet.ahrq.gov/perspective/harm-reduction-strategies-improve-safety-people-who-use-substances

Harm Reduction Strategies to Improve Safety for People Who ...

Harm reduction programs have not been associated with negative outcomes for individuals, communities, or other substance use programs. For ...