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Search / Trial NCT06307340

Adaption of the STAIR-NT Trauma Intervention for Polysubstance Populations

Launched by NYU LANGONE HEALTH · Mar 6, 2024

Trial Information

Current as of June 26, 2025

Recruiting

Keywords

ClinConnect Summary

This clinical trial is looking at a new way to help people who struggle with both substance abuse and symptoms of post-traumatic stress disorder (PTSD). The study will adapt an existing therapy called STAIR-NT to make it easier for individuals who are using both stimulants, like cocaine, and opioids, and are receiving methadone treatment at a clinic in New York City. Over 36 months, researchers will test this adapted therapy in a pilot program with 80 participants to see if it is effective and acceptable. Participants will be randomly chosen to either receive the new therapy or continue with standard treatment.

To be eligible for the study, individuals must be at least 18 years old, be receiving methadone for opioid use disorder, and have a history of using both cocaine and opioids together. They also need to have some signs of PTSD. Participants who join the study will have the chance to receive this new therapy from trained counselors, which is designed to help them manage their symptoms better. It’s important to note that individuals who have certain cognitive impairments, do not speak English, or have other specific circumstances may not be able to participate.

Gender

ALL

Eligibility criteria

  • Inclusion Criteria:
  • must be 18 years or older,
  • be a patient at the START clinic receiving methadone for treatment of opioid use disorder,
  • self-report 10+ days of co-use of cocaine and illicit opioids in the past 30-days,
  • meet the criteria for stimulant use disorder (cocaine type; mild, moderate or severe) and a score of 3≥ on the PC-PTSD-5.
  • Exclusion Criteria:
  • cognitive impairment that would interfere with their ability to understand study participation as assessed by the researcher,
  • does not speak/understand English at a conversational level,
  • plans to leave the START clinic in the next 60 days,
  • patients who missed methadone doses (inactive) for 30 days or more, or
  • having received clinical care from the interventionist(s) in the past 30 days

About Nyu Langone Health

NYU Langone Health is a premier academic medical center located in New York City, renowned for its commitment to advancing healthcare through innovative research and clinical excellence. As a leading sponsor of clinical trials, NYU Langone Health integrates cutting-edge scientific inquiry with patient-centered care, striving to develop new therapies and improve health outcomes across a wide range of medical conditions. The institution is dedicated to fostering collaboration among researchers, clinicians, and patients, ensuring rigorous adherence to ethical standards and regulatory guidelines in all clinical research initiatives. By leveraging its extensive resources and expertise, NYU Langone Health aims to contribute significantly to the advancement of medical knowledge and the enhancement of patient care.

Locations

Tallahassee, Florida, United States

New York, New York, United States

Brooklyn, New York, United States

Patients applied

0 patients applied

Trial Officials

Amanda Bunting

Principal Investigator

NYU Langone Health

Timeline

First submit

Trial launched

Trial updated

Estimated completion

Not reported