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Recruiting NCT05776316

Harm Reduction Services

No phase Interventional Drug Use Substance Abuse Mental Illness

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Integrated Harm Reduction Intervention (IHRI).
Who it may be relevant to
Registry conditions: Drug Use, Substance Abuse, Mental Illness. Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
United States
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

Culturally Response Integrated Harm Reduction Services for Black and Latinx People Who Use Drugs

Overview

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).

Interventions

  • Behavioral Integrated Harm Reduction Intervention (IHRI)
    8-week program targeting areas rooted in the 8 principles of harm reduction. Includes weekly education lessons and informed referrals to social service organizations.

Primary outcome measures

  • Percentage of Participants who Attend At least 1 Harm Reduction (HR) Session after Introductory HR Session [Time frame: Up to Week 8]
  • Percentage of Participants who Attend at least 3 HR Sessions in Total [Time frame: Up to Week 8]
Secondary outcome measures (3)
  • Change from Baseline in Number of Days of Opioid/Other Stimulant Use [Time frame: Baseline, Week 8]
  • Change from Baseline in Overdose Risk Assessment Tool Score [Time frame: Baseline, Week 8]
  • Change from Baseline in Brief Quality of Life Scale Score [Time frame: Baseline, Week 8]

Eligibility criteria

Inclusion criteria

  • at least 18 years of age
  • self-identified as misusing opioids +/- other substances (stimulants) in the past 30 days, confirmed by interview using DSM-5 criteria
  • English or Spanish speaking
  • able to provide informed consent.

Exclusion criteria

  • inability to provide informed consent or participate in the study procedures as proposed in the consent
  • active suicidal or homicidal ideation or an unstable psychotic disorder (schizophrenia, schizoaffective disorder) or mood disorder (bipolar disorder, severe major depressive disorder)
  • an unwillingness to be randomized.
  • are prisoners

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Open label
Primary purpose
Health services research

Study locations

United States · 3 centers
  • Yale University — New Haven
  • NYU Langone Health — New York
  • Nathan Kline Institute — Orangeburg

Identifiers

NCT: NCT05776316 · 22-01089

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗