Adaption of the STAIR-NT Trauma Intervention for Polysubstance Populations

Not Applicable

Recruiting

• Conditions: Posttraumatic Stress Disorder; Polysubstance Abuse
• Interventions: Behavioral: Treatment as Usual; Behavioral: Skills Training in Affective and Interpersonal Regulation with Narrative Therapy (STAIR-NT)

• Registration Number: NCT06307340
• Lead Sponsor: NYU Langone Health

Brief 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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2024-03-06
• Study First Submitted QC: 2024-03-06
• Study First Posted: 2024-03-12
• Study Start: 2024-10-14
• Status Verified: 2025-04
• Last Update Submitted: 2025-04-08
• Last Update Posted: 2025-04-09
• Primary Completion: 2026-01-30
• Study Completion: 2026-04-30

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 80

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Treatment as Usual (TAU)	Treatment as Usual	-
Adapted STAIR-NT Intervention	Skills Training in Affective and Interpersonal Regulation with Narrative Therapy (STAIR-NT)	-

Primary Outcome Measures

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

Trial Locations

Locations (3)

Florida State University; 🇺🇸 Tallahassee, Florida, United States

START Treatment and Recovery Centers; 🇺🇸 Brooklyn, New York, United States

NYU Langone Health; 🇺🇸 New York, New York, United States