Posttraumatic Stress Disorder (PTSD)OPTIMONCT06872164
Open Pilot Trial of Adapted Cognitive Processing Therapy for Comorbid PTSD and Opioid Use Disorder
A study testing Cognitive Processing Therapy in people with Posttraumatic Stress Disorder (PTSD) and Opioid Use Disorder, run by The City College of New York at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Posttraumatic Stress Disorder (PTSD), Opioid Use Disorder
- What is being tested?
- Cognitive Processing Therapy
- Type of treatment
- Injection or infusion, Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 11 participants
- Where
- 1 siteUnited States
- Study dates
- 17 Nov 2025to Sep 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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)
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- Ability to understand English
- Consent to have assessment interviews audio recorded and teletherapy sessions video recorded for research purposes
- Ability to provide informed consent
Who cannot join
- 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).
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Onsite PTSD Treatment to Improve MOUD Outcomes: Open Pilot Trial of Stakeholder-engaged Adapted Cognitive Processing Therapy
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)?
Read more
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
- Being tested
- Cognitive Processing Therapy
- Medical subject headings
- Stress Disorders, Post-Traumatic, Opioid-Related Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cognitive Processing TherapyBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| Adapted Cognitive Processing Therapy | Experimental | 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. Receives: Behavioral: Cognitive Processing Therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Proportion of Eligible Participants
Proportion of persons eligible to enroll in the study of all possible SSP clients approached during 6-month recruitment period. Assessed using count data of individuals failing screen.
Measured: Baseline
Proportion of Eligible Participants who Enroll
Proportion of all eligible persons who enroll. Assessed using count data of individuals consented.
Measured: Week 1
Mean Number of Intervention Sessions Attended
Mean number of teletherapy sessions attended by enrolled participants. Assessed using count data of session attendance.
Measured: Up to Week 12
Proportion of Study Visits Completed by Enrolled Participants
Proportion of study visits completed by enrolled participants. Assessed using count data of study visit attendance.
Measured: Week 12
Proportion of Participants With at Least one SSP-based Coach Encounter
Proportion of participants who have attended at least one teletherapy sessions and have had at least one SSP-based coach encounters.
Measured: Week 12
Participant-rated Client Satisfaction Questionnaire Score
8-item, participant-rated assessment of satisfaction with intervention. Total score is the sum of responses and ranges from 8 to 32. Higher scores indicate greater client satisfaction and treatment acceptability.
Measured: Week 12
Therapist & Coach-Rated Feasibility of Intervention Measure Score
Four-item, clinician-rated assessment of the feasibility of the intervention. Each item is rated on a scale from 1 (Completely disagree) to 5 (Completely agree); the total score is the sum of responses and ranges from 4-20. Higher scores indicate greater clinician-rated feasibility.
Measured: Week 12
Therapist & Coach-Rated Acceptability of Intervention Measure Score
Four-item, clinician-rated assessment of the acceptability of the intervention. Each item is rated on a scale from 1 (Completely disagree) to 5 (Completely agree); the total score is the sum of responses and ranges from 4-20. Higher scores indicate greater clinician-rated acceptability.
Measured: Week 12
Therapist & Coach-Rated Intervention Appropriateness Measure Score
Four-item, clinician-rated assessment of whether the intervention is appropriate for the setting and target population. Each item is rated on a scale from 1 (Completely disagree) to 5 (Completely agree); the total score is the sum of responses and ranges from 4-20. Higher scores indicate greater clinician-rated appropriateness.
Measured: Week 12
Secondary outcomes (3)
Change From Baseline in PCL-5 Total Score
The PCL-5 has 20 items assessing PTSD symptom severity. Total scores range from 0-80 with higher scores indicating more severe PTSD symptoms. The score at baseline will be subtracted from the score at week 12.
Measured: Baseline and Week 12
Changes from baseline in self-reported past 30-day use of prescribed MOUD
Number of self-reported days in the past 30 days in which prescribed MOUD was taken. The number at baseline will be subtracted from the number at week 12.
Measured: Baseline and Week 12
Changes from baseline in self-reported days of nonprescribed opioids
Number of self-reported days of nonprescribed opioids in past 30 days using the Drug Use section of the Addiction Severity Index. The number at baseline will be subtracted from the number at 12 weeks.
Measured: Baseline and Week 12
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Mar 2025
- Study start17 Nov 2025
- Primary completionAug 2026 (estimated)
- Study completionSep 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Posttraumatic Stress Disorder (PTSD)Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 11 participants (actual)
Sponsor and investigators
- Lead sponsor
- The City College of New York
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute on Drug Abuse (NIDA), Albert Einstein College of Medicine
- Responsible party
- Principal investigator, Teresa Lopez-Castro, The City College of New York
- Investigators
- Teresa Lopez-Castro, PhD, Principal investigator, The City College of New York, CUNYAaron D Fox, MD, Principal investigator, Albert Einstein College of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06872164
- Sponsor's protocol ID
- IRB# 2025-16601
- Other IDs
- R61DA059032
- Acronym
- OPTIMO
- Status last verified
- May 2026
- First submitted
- 5 Mar 2025
- Last updated
- 22 May 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: All collected, deidentified individual patient data from enrolled participants of the open trial will be shared. Final datasets will include self-reported psychosocial, demographic, and behavioral data from interviews, and urine toxicology data.
Study at a glance
From the registry record, last updated by the sponsor on 22 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Onsite PTSD Treatment to Improve MOUD Outcomes: Open Pilot Trial of Stakeholder-engaged Adapted Cognitive Processing Therapy
- ClinicalTrials.gov ID
- NCT06872164
- Acronym / sponsor ID
- OPTIMO / IRB# 2025-16601
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 11 participants (actual)
- Lead sponsor
- The City College of New YorkUniversity, hospital or other
- Collaborators
- National Institute on Drug Abuse (NIDA), Albert Einstein College of Medicine
- Study start
- 17 Nov 2025 (actual)
- Primary completion
- Aug 2026 (estimated)
- Study completion
- Sep 2026 (estimated)
- First posted
- 12 Mar 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Adapted Cognitive Processing Therapy | Experimental | Behavioral: Cognitive Processing TherapyParticipants 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- 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)
Key exclusion criteria (4 listed)
- 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).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Cognitive Processing TherapyCognitive 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. | Behavioural | Adapted Cognitive Processing Therapy |
Primary outcome
Proportion of Eligible Participants
Time frame: Baseline
Proportion of persons eligible to enroll in the study of all possible SSP clients approached during 6-month recruitment period. Assessed using count data of individuals failing screen.
Proportion of Eligible Participants who Enroll
Time frame: Week 1
Proportion of all eligible persons who enroll. Assessed using count data of individuals consented.
Mean Number of Intervention Sessions Attended
Time frame: Up to Week 12
Mean number of teletherapy sessions attended by enrolled participants. Assessed using count data of session attendance.
Proportion of Study Visits Completed by Enrolled Participants
Time frame: Week 12
Proportion of study visits completed by enrolled participants. Assessed using count data of study visit attendance.
Proportion of Participants With at Least one SSP-based Coach Encounter
Time frame: Week 12
Proportion of participants who have attended at least one teletherapy sessions and have had at least one SSP-based coach encounters.
Participant-rated Client Satisfaction Questionnaire Score
Time frame: Week 12
8-item, participant-rated assessment of satisfaction with intervention. Total score is the sum of responses and ranges from 8 to 32. Higher scores indicate greater client satisfaction and treatment acceptability.
Therapist & Coach-Rated Feasibility of Intervention Measure Score
Time frame: Week 12
Four-item, clinician-rated assessment of the feasibility of the intervention. Each item is rated on a scale from 1 (Completely disagree) to 5 (Completely agree); the total score is the sum of responses and ranges from 4-20. Higher scores indicate greater clinician-rated feasibility.
Therapist & Coach-Rated Acceptability of Intervention Measure Score
Time frame: Week 12
Four-item, clinician-rated assessment of the acceptability of the intervention. Each item is rated on a scale from 1 (Completely disagree) to 5 (Completely agree); the total score is the sum of responses and ranges from 4-20. Higher scores indicate greater clinician-rated acceptability.
Therapist & Coach-Rated Intervention Appropriateness Measure Score
Time frame: Week 12
Four-item, clinician-rated assessment of whether the intervention is appropriate for the setting and target population. Each item is rated on a scale from 1 (Completely disagree) to 5 (Completely agree); the total score is the sum of responses and ranges from 4-20. Higher scores indicate greater clinician-rated appropriateness.
3 secondary outcomes
Change From Baseline in PCL-5 Total Score
Time frame: Baseline and Week 12
Changes from baseline in self-reported past 30-day use of prescribed MOUD
Time frame: Baseline and Week 12
Changes from baseline in self-reported days of nonprescribed opioids
Time frame: Baseline and Week 12
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 May 2026.
- Individual participant dataSharing planned: Yes. All collected, deidentified individual patient data from enrolled participants of the open trial will be shared. Final datasets will include self-reported psychosocial, demographic, and behavioral data from interviews, and urine toxicology data.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Teresa Lopez-Castro, PhD principal investigator
The City College of New York, CUNY
Aaron D Fox, MD principal investigator
Albert Einstein College of Medicine
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Cognitive Processing Therapy in people with Posttraumatic Stress Disorder (PTSD) and Opioid Use Disorder, run by The City College of New York at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 22 May 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Proportion of Eligible Participants (time frame: Baseline). The study lists 9 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 May 2026.