Adaption of the STAIR-NT Trauma Intervention for Polysubstance Populations

NCT06307340 | Active Not Recruiting DMC

• 1 other identifier: 22-01058
• Study Type: interventional
• Target: 76
• Locations: 1 country
• Sites: 3

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.

Conditions

Polysubstance Abuse; Posttraumatic Stress Disorder

Outcome Measures

Primary Outcomes (12)

• 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

Study Arms (2)

Adapted STAIR-NT Intervention

EXPERIMENTAL

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

Treatment as Usual (TAU)

ACTIVE COMPARATOR

Behavioral: Treatment as Usual

Interventions

Treatment as Usual BEHAVIORAL

Treatment as usual.

Treatment as Usual (TAU)

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

Adapted version of evidence-based behavioral PTSD intervention.

Adapted STAIR-NT Intervention

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• NYU Langone Health: lead
• National Institute on Drug Abuse (NIDA): collaborator

Study Sites (3)

Florida State University

Tallahassee, Florida, 32306, United States

Location

START Treatment and Recovery Centers

Brooklyn, New York, 11238, United States

Location

NYU Langone Health

New York, New York, 10016, United States

Location

Related Publications (1)

• 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.

  PMID: 39627789 DERIVED

MeSH Terms

Conditions

Stress Disorders, Post-Traumatic

Interventions

Narrative Therapy; Therapeutics

Condition Hierarchy (Ancestors)

Stress Disorders, Traumatic; Trauma and Stressor Related Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Psychotherapy; Behavioral Disciplines and Activities

Study Officials

• Amanda Bunting

  NYU Langone Health

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: The data analyst is blinded to participant arm.
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 6, 2024
• First Posted: March 12, 2024
• Study Start: October 14, 2024
• Primary Completion (Estimated): June 30, 2026
• Study Completion (Estimated): September 30, 2026
• Last Updated: March 12, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF
• 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.
• 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.

Locations

US (3)