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Harm Reduction Services

ConditionsDrug UseSubstance AbuseMental Illness
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorNYU Langone Health

About 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).

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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.

Disqualifiers

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

Trial design

Design model

Parallel

Treatments tested in this trial

  • Integrated Harm Reduction Intervention (IHRI)

    Behavioral

    8-week program targeting areas rooted in the 8 principles of harm reduction. Includes weekly education lessons and informed referrals to social service organizations.

Treatment groups

200 Participants
are divided into 2 treatment groups
Group A: IHRIExperimental treatment 1 intervention
Group B: HR SAUNo intervention 0 interventions

Trial outcomes

Primary outcomes

1

Percentage of Participants who Attend At least 1 Harm Reduction (HR) Session after Introductory HR Session

Measure of engagement.

Time frame
Up to Week 8
2

Percentage of Participants who Attend at least 3 HR Sessions in Total

Measure of engagement.

Time frame
Up to Week 8

Secondary outcomes

1

Change from Baseline in Number of Days of Opioid/Other Stimulant Use

Number of days of opioid/other stimulant use will be calculated using the timeline follow back method, which asks participants to estimate how many days over the previous 30 days that they used opioids/other stimulants.

Time frame
Baseline, Week 8
2

Change from Baseline in Overdose Risk Assessment Tool Score

20-item assessment of overdose risk. Each item prompts a "Yes" or "No" response. If the response is "Yes," a score is assigned for that item. If the answer is "No," no score is assigned for that item. The total score is the sum of responses and ranges from 0 to 42; lower scores indicate low risk, higher scores indicate higher risk. A decrease in scores indicates risk of overdose decreased during the observatioN period.

Time frame
Baseline, Week 8
3

Change from Baseline in Brief Quality of Life Scale Score

12-item assessment of quality of life. Each item is ranked on a 5-point Likert scale ranging from 0 (do not agree at all) to 4 (agree completely). The total score is the sum of responses and ranges from 0 to 48; higher scores indicate higher quality of life. An increase in scores indicates quality of life increased during the observation period.

Time frame
Baseline, Week 8

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

NYU Langone Health

Lead sponsor

National Institute of General Medical Sciences (NIGMS)

Collaborator

Source ClinicalTrials.gov
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