Adaption of the STAIR-NT Trauma Intervention for Polysubstance Populations

Posttraumatic Stress Disorder Clinical Trial

Official title:

Adaption of the STAIR-NT Trauma Intervention for Polysubstance Populations

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06307340
• Other study ID #: 22-01058
• Status: Not yet recruiting
• Phase: N/A
• Start date: April 2024
• Est. completion date: October 2025

Study information

• Verified date: April 2024
• Source: NYU Langone Health
• Contact: Brittany Griffin
• Phone: 646-501-3564
• Email: Brittany.Griffin[@]nyulangone.org
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 80
• Est. completion date: October 2025
• Est. primary completion date: April 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Polysubstance Abuse
• Posttraumatic Stress Disorder
• Stress Disorders, Post-Traumatic

Intervention

Behavioral:
• Skills Training in Affective and Interpersonal Regulation with Narrative Therapy (STAIR-NT)
Adapted version of evidence-based behavioral PTSD intervention.
• Treatment as Usual
Treatment as usual.

Locations

Country	Name	City	State
United States	START Treatment and Recovery Centers	Brooklyn	New York
United States	NYU Langone Health	New York	New York
United States	Florida State University	Tallahassee	Florida

Sponsors (2)

Lead Sponsor	Collaborator
NYU Langone Health	National Institute on Drug Abuse (NIDA)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	Proportion of Eligible Participants who Enroll	.Proportion of all eligible persons who enroll. Assessed using count data of individuals consented.	Baseline
Primary	Number of Intervention Sessions Completed		Up to Month 3
Primary	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
Primary	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
Primary	Number of Days of Co-Use of Cocaine and Illicit Opioids	Measured using the Addiction Severity Index (ASI) questionnaire.	Month 3
Primary	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
Primary	Number of Substances Used based on Urine Drug Screen		Month 3
Primary	Number of Substances Used based on Chart Abstraction of Toxicology Results		Month 3
Primary	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
Primary	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
Primary	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