Open Pilot Trial of Adapted Cognitive Processing Therapy for Comorbid PTSD and Opioid Use Disorder (NCT06872164) | Clinical Trial Compass
Active — Not RecruitingNot Applicable
Open Pilot Trial of Adapted Cognitive Processing Therapy for Comorbid PTSD and Opioid Use Disorder
United States11 participantsStarted 2025-11-17
Plain-language 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
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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).
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Proportion of Eligible Participants
Timeframe: Baseline
2
Proportion of Eligible Participants who Enroll
Timeframe: Week 1
3
Mean Number of Intervention Sessions Attended
Timeframe: Up to Week 12
4
Proportion of Study Visits Completed by Enrolled Participants
Timeframe: Week 12
5
Proportion of Participants With at Least one SSP-based Coach Encounter