Skip to main content
OpenTrials
Active, Not Recruiting

NCT Number: NCT06307340

Adaption of the STAIR-NT Trauma Intervention for Polysubstance Populations

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.

Active, Not Recruiting

This study is active but is not currently recruiting participants.

Notify Me

Key information

Conditions

Polysubstance Abuse Mental Disorders Posttraumatic Stress Disorder Stress Disorders, Post-Traumatic Stress Disorders, Traumatic Trauma and Stressor Related Disorders

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Florida State University, Tallahassee, Florida, United States

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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

Behavioral

Adapted version of evidence-based behavioral PTSD intervention.

Treatment as Usual

Behavioral

Treatment as usual.

Primary outcomes

  1. Proportion of Eligible Participants

    Time frame: Baseline

    Proportion of persons eligible to enroll in the study of all possible MMT patients approached. Assessed using count data of individuals failing screen.

  2. Proportion of Eligible Participants who Enroll

    Time frame: Baseline

    .Proportion of all eligible persons who enroll. Assessed using count data of individuals consented.

  3. Number of Intervention Sessions Completed

    Time frame: Up to Month 3

  4. Clinician-Rated Feasibility of Intervention Measure (FIM) Score

    Time frame: Month 3

    4-item, clinician-rated assessment of the feasibility of the intervention. Each item is rated on a scale from 1 (Completely disagree) to 5 (Completely agree); the total score is the sum of responses and ranges from 4-20. Higher scores indicate greater clinician-rated feasibility.

  5. Clinician-Rated Feasibility of Acceptability of Intervention Measure (AIM) Score

    Time frame: Month 3

    4-item, clinician-rated assessment of the acceptability of the intervention. Each item is rated on a scale from 1 (Completely disagree) to 5 (Completely agree); the total score is the sum of responses and ranges from 4-20. Higher scores indicate greater clinician-rated acceptability.

  6. Number of Days of Co-Use of Cocaine and Illicit Opioids

    Time frame: Month 3

    Measured using the Addiction Severity Index (ASI) questionnaire.

  7. Number of Substances Used based on ASI Self-Report

    Time frame: Month 3

    Measured using the Addiction Severity Index (ASI) questionnaire, a self-report assessment to gauge the severity of a person's substance abuse.

  8. Number of Substances Used based on Urine Drug Screen

    Time frame: Month 3

  9. Number of Substances Used based on Chart Abstraction of Toxicology Results

    Time frame: Month 3

  10. PTSD Checklist for DSM-5 (PCL-5) Score

    Time frame: Month 3

    The PCL-5 is a 20-item self-report measure that assesses the 20 DSM-5 symptoms of PTSD. Each item is rated on a scale from 0-4. A total symptom severity score (range - 0-80) can be obtained by summing the scores for each of the 20 items; higher scores indicate greater severity of PTSD.

  11. Negative Mood Regulation Scale Score

    Time frame: Month 3

    30-item assessment of individuals' beliefs and expectations regarding their ability to regulate their negative mood and emotions. Each item is rated on a 5-point Likert scale ranging from 1 (not at all effective) to 5 (extremely effective). The total score ranges from 30-150; higher scores indicate more effective negative mood regulation.

  12. Inventory of Interpersonal Problems Score

    Time frame: Month 3

    A 127-item, self-report inventory that asks participants to rate a variety of interpersonal problems that may cause distress. The items are divided into two groups: (1) interpersonal inadequacies or inhibitions (78 items), (2) excesses or compulsions (49 items). Participants rate each item on a scale from 0 to 4 on how much difficulty/distress they feel regarding the item. The total score is calculated by adding the item responses; lower scores indicate less difficulty/distress.

Sponsors and collaborators

Lead sponsor

NYU Langone Health

Other

Collaborators

  • National Institute on Drug Abuse (NIDA)

Registry information

Important dates

Study start
2024
Primary completion
2026
Study completion
2026
First posted
Mar 12, 2024
Registry last updated
Mar 12, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.