Clinical trial NCT06307340: Adaption of the STAIR-NT Trauma Intervention for Polysubstance Populations
Official title: Adaption of the STAIR-NT Trauma Intervention for Polysubstance Populations
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Polysubstance Abuse
Posttraumatic Stress Disorder
Lead sponsor: NYU Langone Health
Sponsor class: OTHER
Collaborators: name: National Institute on Drug Abuse (NIDA)
First posted: 2024-03-12
Enrollment: 80
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: HEALTH_SERVICES_RESEARCH

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.


Eligibility criteria: 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

Primary outcomes:
measure: Proportion of Eligible Participants
timeFrame: Baseline
measure: Proportion of Eligible Participants who Enroll
timeFrame: Baseline
measure: Number of Intervention Sessions Completed
timeFrame: Up to Month 3
measure: Clinician-Rated Feasibility of Intervention Measure (FIM) Score
timeFrame: Month 3
measure: Clinician-Rated Feasibility of Acceptability of Intervention Measure (AIM) Score
timeFrame: Month 3
measure: Number of Days of Co-Use of Cocaine and Illicit Opioids
timeFrame: Month 3
measure: Number of Substances Used based on ASI Self-Report
timeFrame: Month 3
measure: Number of Substances Used based on Urine Drug Screen
timeFrame: Month 3
measure: Number of Substances Used based on Chart Abstraction of Toxicology Results
timeFrame: Month 3
measure: PTSD Checklist for DSM-5 (PCL-5) Score
timeFrame: Month 3
measure: Negative Mood Regulation Scale Score
timeFrame: Month 3
measure: Inventory of Interpersonal Problems Score
timeFrame: Month 3
Secondary outcomes:
Other outcomes:
Locations:
city: Tallahassee
country: United States
facility: Florida State University
state: Florida
city: Brooklyn
country: United States
facility: START Treatment and Recovery Centers
state: New York
city: New York
country: United States
facility: NYU Langone Health
state: New York
Study officials:
affiliation: NYU Langone Health
name: Amanda Bunting
role: PRINCIPAL_INVESTIGATOR
References: