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.

Study Overview

• Status: Active, not recruiting
• Conditions: Posttraumatic Stress Disorder; Polysubstance Abuse
• Intervention / Treatment: Behavioral: Skills Training in Affective and Interpersonal Regulation with Narrative Therapy (STAIR-NT); Behavioral: Treatment as Usual

• Study Type: Interventional
• Enrollment (Actual): 76
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Florida
    • Tallahassee, Florida, United States, 32306
      • Florida State University
  • New York
    • Brooklyn, New York, United States, 11238
      • START Treatment and Recovery Centers
    • New York, New York, United States, 10016
      • NYU Langone Health

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Health Services Research
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Treatment as Usual (TAU)	Behavioral: Treatment as Usual; Treatment as usual.
Experimental: Adapted STAIR-NT Intervention	Behavioral: Skills Training in Affective and Interpersonal Regulation with Narrative Therapy (STAIR-NT); Adapted version of evidence-based behavioral PTSD intervention.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Proportion of Eligible Participants	Proportion of persons eligible to enroll in the study of all possible MMT patients approached. Assessed using count data of individuals failing screen.	Baseline
Proportion of Eligible Participants who Enroll	.Proportion of all eligible persons who enroll. Assessed using count data of individuals consented.	Baseline
Number of Intervention Sessions Completed		Up to Month 3
Clinician-Rated Feasibility of Intervention Measure (FIM) Score	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.	Month 3
Clinician-Rated Feasibility of Acceptability of Intervention Measure (AIM) Score	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.	Month 3
Number of Days of Co-Use of Cocaine and Illicit Opioids	Measured using the Addiction Severity Index (ASI) questionnaire.	Month 3
Number of Substances Used based on ASI Self-Report	Measured using the Addiction Severity Index (ASI) questionnaire, a self-report assessment to gauge the severity of a person's substance abuse.	Month 3
Number of Substances Used based on Urine Drug Screen		Month 3
Number of Substances Used based on Chart Abstraction of Toxicology Results		Month 3
PTSD Checklist for DSM-5 (PCL-5) Score	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.	Month 3
Negative Mood Regulation Scale Score	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.	Month 3
Inventory of Interpersonal Problems Score	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.	Month 3

Collaborators and Investigators

• Sponsor: NYU Langone Health
• Collaborators: National Institute on Drug Abuse (NIDA)
• Investigators: Principal Investigator: Amanda Bunting, NYU Langone Health

Publications and helpful links

General Publications

• Renn T, Griffin B, Kumaravelu V, Ventuneac A, Santacatterina M, Bunting AM. Study protocol for a randomized controlled trial to adapt a posttraumatic stress disorder intervention of patients with opioid-stimulant polysubstance use receiving methadone maintenance treatment. BMC Psychiatry. 2024 Dec 4;24(1):879. doi: 10.1186/s12888-024-06348-0.

Study record dates

Study Major Dates

• Study Start (Actual): October 14, 2024
• Primary Completion (Estimated): June 30, 2026
• Study Completion (Estimated): September 30, 2026

Study Registration Dates

• First Submitted: March 6, 2024
• First Submitted That Met QC Criteria: March 6, 2024
• First Posted (Actual): March 12, 2024

Study Record Updates

• Last Update Posted (Actual): March 12, 2026
• Last Update Submitted That Met QC Criteria: March 10, 2026
• Last Verified: March 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Trauma and Stressor Related Disorders; Mental Disorders; Stress Disorders, Traumatic; Stress Disorders, Post-Traumatic; Psychotherapy; Behavioral Disciplines and Activities; Therapeutics; Narrative Therapy
• Other Study ID Numbers: 22-01058

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: Deidentified quantitative assessment data will be shared upon reasonable request beginning 9 months and ending 36 months following article publication or as required by a condition of awards and agreements supporting the research. Data will be stored in a data repository. The protocol and statistical analysis plan will be made available on Clinicaltrials.gov only as required by federal regulation or as a condition of awards and agreements supporting the research.
• IPD Sharing Time Frame: Beginning 9 months and ending 36 months following article publication or as required by a condition of awards and agreements supporting the research.
• IPD Sharing Access Criteria: The investigator who proposed to use the data will be granted access upon reasonable request. The data will be stored in a data repository.
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP; ICF

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No