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

NCT ID: NCT06872164

Last Updated: 2025-12-05

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 15 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-11-17
• Study Completion Date: 2026-09-30

Brief 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

Conditions

Posttraumatic Stress Disorder (PTSD); Opioid Use Disorder

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Adapted Cognitive Processing Therapy

Participants will receive 4-18 sessions of telehealth-delivered Cognitive Processing Therapy (CPT) adapted for people who use syringe services programs. Participants will attend the 50-minute CPT sessions in a private space within the syringe services program.

Group Type: EXPERIMENTAL

Cognitive Processing Therapy

Intervention Type: BEHAVIORAL

Cognitive Processing Therapy (CPT) is an evidence-based psychotherapy for PTSD that provides education and teaches skills to challenge the trauma-related beliefs that maintain PTSD symptoms. In this study, CPT has been adapted to include content on the relationship between substance use and PTSD and a focus on harm reduction.

Interventions

Cognitive Processing Therapy

Cognitive Processing Therapy (CPT) is an evidence-based psychotherapy for PTSD that provides education and teaches skills to challenge the trauma-related beliefs that maintain PTSD symptoms. In this study, CPT has been adapted to include content on the relationship between substance use and PTSD and a focus on harm reduction.

Intervention Type: BEHAVIORAL

Eligibility Criteria

Inclusion Criteria

• Over the age of 18
• Regular syringe services program attendance (ex. at least 4 visits in the past month)
• Meeting DSM-5 opioid use disorder criteria
• Having been prescribed a medication for opioid use disorder in the past 30 days at the time of screening
• Criterion A event as measured by the Life Events Checklist for DSM-5 (LEC-5)
• PTSD symptoms at the level of a PTSD diagnosis as evidenced by a score of 31 or greater on the PTSD Checklist for DSM-5 (PCL-5)
• Ability to understand English
• Consent to have assessment interviews audio recorded and teletherapy sessions video recorded for research purposes
• Ability to provide informed consent

Exclusion Criteria

• High risk for suicidal thoughts and/or behaviors that would make participation dangerous, as measured by the Columbia Suicide Severity Rating Scale Lifetime-Recent Screen
• Meeting DSM-5 criteria for a current psychotic or bipolar disorder.
• Cognitive impairment liable to interfere with completion of study procedures
• Currently receiving trauma-focused psychotherapy (i.e. Prolonged Exposure, Cognitive Processing Therapy).

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

National Institute on Drug Abuse (NIDA)

NIH

Sponsor Role: collaborator

Albert Einstein College of Medicine

OTHER

Sponsor Role: collaborator

The City College of New York

OTHER

Sponsor Role: lead

Responsible Party

Teresa Lopez-Castro

Associate Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Teresa Lopez-Castro, PhD

Role: PRINCIPAL_INVESTIGATOR

The City College of New York, CUNY

Aaron D Fox, MD

Role: PRINCIPAL_INVESTIGATOR

Albert Einstein College of Medicine

Locations

OnPoint

New York, New York, United States

Site Status: RECRUITING

Countries

United States

Central Contacts

Teresa Lopez-Castro, PhD

Role: CONTACT

tlopezcastro@ccny.cuny.edu

646-745-7123

Aaron D Fox, MD

Role: CONTACT

adfox@montefiore.org

718-920-7173

Facility Contacts

Teresa Lopez-Castro, PhD

Role: primary

tlopezcastro@ccny.cuny.edu

347-644-7213

Other Identifiers

R61DA059032

Identifier Type: NIH

Identifier Source: secondary_id

View Link

IRB# 2025-16601

Identifier Type: -

Identifier Source: org_study_id