Trials / Active Not Recruiting
Active Not RecruitingNCT06307340
Adaption of the STAIR-NT Trauma Intervention for Polysubstance Populations
- Status
- Active Not Recruiting
- Phase
- N/A
- Study type
- Interventional
- Enrollment
- 76 (actual)
- Sponsor
- NYU Langone Health · Academic / Other
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
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
Interventions
| Type | Name | Description |
|---|---|---|
| BEHAVIORAL | Skills Training in Affective and Interpersonal Regulation with Narrative Therapy (STAIR-NT) | Adapted version of evidence-based behavioral PTSD intervention. |
| BEHAVIORAL | Treatment as Usual | Treatment as usual. |
Timeline
- Start date
- 2024-10-14
- Primary completion
- 2026-06-30
- Completion
- 2026-09-30
- First posted
- 2024-03-12
- Last updated
- 2026-03-12
Locations
3 sites across 1 country: United States
Source: ClinicalTrials.gov record NCT06307340. Inclusion in this directory is not an endorsement.