Active — Not RecruitingNot Applicable

Adaption of the STAIR-NT Trauma Intervention for Polysubstance Populations

United States76 participantsStarted 2024-10-14

Plain-language 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.

Who can participate

Age range

18 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Proportion of Eligible Participants

Timeframe: Baseline

Proportion of Eligible Participants who Enroll

Timeframe: Baseline

Number of Intervention Sessions Completed

Timeframe: Up to Month 3

Clinician-Rated Feasibility of Intervention Measure (FIM) Score

Timeframe: Month 3

Clinician-Rated Feasibility of Acceptability of Intervention Measure (AIM) Score

Timeframe: Month 3

Number of Days of Co-Use of Cocaine and Illicit Opioids

Timeframe: Month 3

Number of Substances Used based on ASI Self-Report

Timeframe: Month 3

Number of Substances Used based on Urine Drug Screen

Trial details

NCT IDNCT06307340

SponsorNYU Langone Health

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2026-06-30

View on ClinicalTrials.gov More Polysubstance Abuse trials

Plain-language summary

Who can participate

Age range

18 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

What they're measuring

Proportion of Eligible Participants

Timeframe: Baseline

Proportion of Eligible Participants who Enroll

Timeframe: Baseline

Number of Intervention Sessions Completed

Timeframe: Up to Month 3

Clinician-Rated Feasibility of Intervention Measure (FIM) Score

Timeframe: Month 3

Clinician-Rated Feasibility of Acceptability of Intervention Measure (AIM) Score

Timeframe: Month 3

Number of Days of Co-Use of Cocaine and Illicit Opioids

Timeframe: Month 3

Number of Substances Used based on ASI Self-Report

Timeframe: Month 3

Number of Substances Used based on Urine Drug Screen