Adaption of the STAIR-NT Trauma Intervention for Polysubstance Populations

Last updated: April 8, 2025
Sponsor: NYU Langone Health
Overall Status: Active - Recruiting

Phase

N/A

Condition

Post-traumatic Stress Disorders

Treatment

Treatment as Usual

Skills Training in Affective and Interpersonal Regulation with Narrative Therapy (STAIR-NT)

Clinical Study ID

NCT06307340
22-01058
  • Ages > 18
  • All Genders

Study Summary

During this 36-month R34 trial, eight study phases are proposed to adapt an evidence-based post traumatic stress disorder (PTSD) intervention (STAIR-NT) and layer it into a methadone maintenance treatment (MMT) program (START Treatment and Recovery centers) in New York City for use among individuals engaged in stimulant-opioid polysubstance use. The study aims to adapt STAIR-NT to a massed treatment schedule. Once an adapted protocol is complete, it will be tested for feasibility, acceptability, and short-term polysubstance and PTSD symptomology outcomes in a pilot randomized control trial (RCT) of 80 participants. Participants who screen eligible and consent will be randomized 1:1 to the adapted STAIR-NT intervention or treatment as usual (TAU) using randomization blocks of two and two and four via a computer-generated randomization sequence. Participants assigned to the intervention will receive the adapted massed delivery of STAIR-NT by trained counselors.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • must be 18 years or older,

  • be a patient at the START clinic receiving methadone for treatment of opioid usedisorder,

  • 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 orsevere) and a score of 3≥ on the PC-PTSD-5.

Exclusion

Exclusion Criteria:

  • cognitive impairment that would interfere with their ability to understand studyparticipation 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

Study Design

Total Participants: 80
Treatment Group(s): 2
Primary Treatment: Treatment as Usual
Phase:
Study Start date:
October 14, 2024
Estimated Completion Date:
April 30, 2026

Connect with a study center

  • Florida State University

    Tallahassee, Florida 32306
    United States

    Active - Recruiting

  • START Treatment and Recovery Centers

    Brooklyn, New York 11238
    United States

    Active - Recruiting

  • NYU Langone Health

    New York, New York 10016
    United States

    Active - Recruiting

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