Adapting a PTSD intervention for people using multiple substances
Adaption of the STAIR-NT Trauma Intervention for Polysubstance Populations
This study is testing a new version of a PTSD treatment for people using multiple substances to see if it works better than the usual care they receive.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 80 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | NYU Langone Health Academic / other |
| Locations | 3 sites (Tallahassee, Florida and 2 other locations) |
| Trial ID | NCT06307340 on ClinicalTrials.gov |
What this trial studies
This clinical trial aims to adapt an evidence-based PTSD intervention, STAIR-NT, for individuals engaged in stimulant-opioid polysubstance use within a methadone maintenance treatment program. Over 36 months, the study will involve eight phases to modify the intervention for a massed treatment schedule. Once adapted, the protocol will be tested for feasibility and acceptability in a pilot randomized control trial with 80 participants, comparing the adapted intervention to standard treatment. Participants will be randomized to receive either the adapted STAIR-NT or treatment as usual, with trained counselors delivering the intervention.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18 and older who are receiving methadone treatment for opioid use disorder and have a history of co-use of cocaine and illicit opioids.
Not a fit: Patients who have cognitive impairments, do not speak English at a conversational level, or have recently received care from the interventionists may not benefit from this study.
Why it matters
Potential benefit: If successful, this intervention could significantly improve PTSD symptoms and substance use outcomes for individuals with polysubstance abuse.
How similar studies have performed: Other studies have shown promise in adapting PTSD interventions for substance use populations, suggesting potential for success in this approach.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
Tallahassee, Florida and 2 other locations
- Florida State University — Tallahassee, Florida, United States (Recruiting)
- START Treatment and Recovery Centers — Brooklyn, New York, United States (Recruiting)
- NYU Langone Health — New York, New York, United States (Recruiting)
Study contacts
- Principal investigator: Amanda Bunting — NYU Langone Health
- Study coordinator: Brittany Griffin
- Email: Brittany.Griffin@nyulangone.org
- Phone: 646-501-3564
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.