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

Trial Summary

What is the purpose of this trial?

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 harm reduction service utilization among Black and Latinx people who use drugs (PWUD).

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 data supports the effectiveness of the Integrated Harm Reduction Intervention (IHRI) treatment for substance use disorders?

Research shows that combining harm reduction with abstinence-based treatment is more effective than using either approach alone, especially in keeping patients engaged in treatment. Harm reduction strategies have been successful in reducing the negative effects of substance use and are adaptable to various behavioral disorders, providing valuable options for those not ready for full abstinence. ^{1 2 3 4 5}

Is the Integrated Harm Reduction Intervention (IHRI) generally safe for humans?

In a study of psychosocial treatments for substance use disorders, 12% of participants experienced serious adverse events, but none were related to the study itself, suggesting that such interventions are generally safe. ^{6 7 8 9 10}

How is the Integrated Harm Reduction Intervention (IHRI) treatment different from other treatments for substance use disorders?

The Integrated Harm Reduction Intervention (IHRI) is unique because it focuses on reducing the harmful effects of substance use without requiring people to completely stop using substances. This approach is different from traditional treatments that often emphasize abstinence (completely stopping substance use) as the primary goal. ^{4 11 12 13 14}

Research Team

Ayana Jordan, MD, PhD

Principal Investigator

NYU Langone Health

Eligibility Criteria

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

I am 18 years old or older.

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

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

Treatment Details

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.

Participant Groups

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+

Findings from Research

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]

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 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]

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]

References

1. United States pubmed.ncbi.nlm.nih.gov

Integrating harm reduction and abstinence-based substance abuse treatment in the public sector. [2015]

2. United States pubmed.ncbi.nlm.nih.gov

Harm reduction psychotherapy: extending the reach of traditional substance use treatment. [2019]

3. England pubmed.ncbi.nlm.nih.gov

Integrated versus non-integrated management and care for clients with co-occurring mental health and substance use disorders: a qualitative systematic review of randomised controlled trials. [2022]

4. United States pubmed.ncbi.nlm.nih.gov

Harm reduction therapy: a practice-friendly review of research. [2022]

5. England pubmed.ncbi.nlm.nih.gov

Pharmacological treatments for drug misuse and dependence. [2020]

6. England pubmed.ncbi.nlm.nih.gov

Strategies for safety reporting in substance abuse trials. [2013]

7. United States pubmed.ncbi.nlm.nih.gov

Serious adverse events in randomized psychosocial treatment studies: safety or arbitrary edicts? [2021]

8. England pubmed.ncbi.nlm.nih.gov

Serious adverse events in the Australian National Evaluation of Pharmacotherapies for Opioid Dependence (NEPOD). [2022]

9. United States pubmed.ncbi.nlm.nih.gov

Development and Usability Testing of a System to Detect Adverse Events and Medical Mistakes. [2023]

10. Switzerland pubmed.ncbi.nlm.nih.gov

The Incident Feedback Committee (IFC): A Useful Tool to Investigate Errors in Clinical Research. [2022]

11. United States pubmed.ncbi.nlm.nih.gov

Integrative harm reduction psychotherapy: a case of substance use, multiple trauma, and suicidality. [2010]

12. Switzerland pubmed.ncbi.nlm.nih.gov

Identifying barriers and facilitators for implementing harm reduction strategies for methamphetamine use into hospital settings. [2023]

13. United States pubmed.ncbi.nlm.nih.gov

Harm Reduction in Health Care Settings. [2021]

14. England pubmed.ncbi.nlm.nih.gov

Clinical harm reduction in substance use: An ethics-oriented primer and critique for hospital-based providers. [2023]