Clinical Trial

Open Pilot Trial of Adapted Cognitive Processing Therapy for Comorbid PTSD and Opioid Use Disorder

Study acronym: OPTIMO
Active, Not Recruiting
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Summary
The goal of this open pilot trial is to learn if an adapted version of Cognitive Processing Therapy (CPT), delivered through telehealth, can treat posttraumatic stress disorder (PTSD) in adults who use syringe services programs. The main questions it aims to answer are: * Can the intervention be done in syringe services programs? * Are syringe services program clients and staff open to the intervention? * Can the intervention lower PTSD symptoms and help participants keep taking their medication for opioid use disorder (ex. Buprenorphine or methadone)? Participants will: * Attend 4-18 tele-delivered CPT sessions at the syringe services program * Complete between-session CPT practice with the support of SSP-based "coaches" * Meet with research staff monthly to complete surveys of their PTSD symptoms, drug use, and mental health
Protocol Amendment History 2 amendments
This ClinicalTrials.gov record has been amended 2 times since 2025-03-10; most recent amendment 2026-05-19.
Status change: Recruiting → Active, Not Recruiting 2026-05-19
Status change: Not Yet Recruiting → Recruiting 2025-11-29
Trial Details
NCT Number NCT06872164
Lead Sponsor The City College of New York
Collaborators: National Institute on Drug Abuse (NIDA), Albert Einstein College of Medicine
Conditions Posttraumatic Stress Disorder (PTSD), Opioid Use Disorder
Enrollment 11 participants
Start Date 2025-11-17
Primary Completion 2026-08 (estimated)
Study Completion 2026-09 (estimated)
Updated on ClinicalTrials.gov 2026-05-22