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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

TypeNameDescription
BEHAVIORALSkills Training in Affective and Interpersonal Regulation with Narrative Therapy (STAIR-NT)Adapted version of evidence-based behavioral PTSD intervention.
BEHAVIORALTreatment as UsualTreatment 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.