Opioid Use DisorderNCT06288711
Novel Telemedicine-Delivered Prolonged Exposure Therapy for Treating PTSD in Individuals With OUD
A study testing Prolonged exposure therapy, Financial incentives and Treatment as usual in people with Opioid Use Disorder and Posttraumatic Stress Disorder, run by University of Vermont at 1 site in United States.
Trial summary
Among individuals with opioid use disorder (OUD), posttraumatic stress disorder (PTSD) presents a significant clinical challenge. The prevalence of PTSD is substantially higher in individuals with OUD than in the general population, with nearly 90% reporting lifetime trauma exposure and 33% meeting diagnostic criteria… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Opioid Use Disorder, Posttraumatic Stress Disorder
- What is being tested?
- Prolonged exposure therapy, Financial incentives and Treatment as usual
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 135 participants
- Where
- 1 siteUnited States
- Study dates
- 3 Jun 2024to 30 Nov 2027
- 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
- >18 years old
- Maintained on a stable methadone or buprenorphine dose for >1 month prior to the study
- Meet current DSM-5 posttraumatic stress disorder criteria based on the Clinician Administered PTSD Scale for DSM-5
- Participants receiving psychotropic medications must be maintained on a stable dose for >1 month prior to enrollment.
Who cannot join
- Current delusions or hallucinations, unstable bipolar disorder, imminent risk for suicide as assessed by the Mini International Neuropsychiatric Interview
- Cognitive impairment as evidenced by scores <22 on the Videoconference-based Mini Mental Status Examination (MMSE; Folstein, et al., 1975)
- Enrolled in another ongoing evidence-based treatment for PTSD.
- Pregnancy as verified by pregnancy test
- No access to cellular service
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
University of Vemont
Burlington, Vermont, 05401
Kelly R Peck, Ph.D., 8026569610, Kelly.Peck@uvm.edu
About this study
Among individuals with opioid use disorder (OUD), posttraumatic stress disorder (PTSD) presents a significant clinical challenge. The prevalence of PTSD is substantially higher in individuals with OUD than in the general population, with nearly 90% reporting lifetime trauma exposure and 33% meeting diagnostic criteria for PTSD. The primary objective of this study is to evaluate the efficacy of a novel telemedicine-delivered prolonged exposure therapy protocol for improving PE attendance and reducing PTSD symptom severity in individuals with concurrent PTSD and OUD.
Read the detailed description
Nearly 90% of individuals with opioid use disorder (OUD) report lifetime trauma exposure and 33% meet criteria for posttraumatic stress disorder (PTSD). Patients with co-occurring PTSD and OUD are at significantly greater risk for poor substance use and mental health outcomes vs. those with OUD alone. Although Prolonged Exposure (PE) therapy is a first-line treatment for PTSD, its efficacy is commonly undermined by poor attendance.
The primary objective of this study is to evaluate the efficacy of a novel telemedicine-delivered prolonged exposure therapy protocol for improving PE attendance and reducing PTSD symptom severity in individuals with concurrent PTSD and OUD. In this randomized trial, adults with PTSD (N = 135) who are currently maintained on MOUD will be randomly assigned to one of three conditions: (a) Treatment as usual (TAU), (b) Prolonged exposure therapy (PE), or (c) Prolonged exposure therapy + attendance-contingent financial incentives (PE+). Participants randomized to the TAU condition will continue to receive standard MOUD treatment from their current treatment provider and complete remotely-administered assessments of PTSD symptoms, psychosocial functioning and drug use with an evaluator trained in the administration of all study measures and blinded to treatment condition at intake, monthly during the 12-week intervention, and at 3- and 6-months post-study, but will not receive PTSD treatment. In addition to receiving continued MOUD treatment from their current provider and completing assessments as above, participants assigned to PE will also receive telemedicine-delivered PE consisting of 12 weekly, individual sessions with trained master's- or doctoral-level therapists. PE sessions consist of imaginal exposure (i.e., revisiting and recounting traumatic memories) and processing the memory (i.e., discussing thoughts and feelings related to revisiting the memory). Participants also complete homework assignments consisting of repeated listening to a recording of the imaginal exposure and repeated in vivo exposure to safe situations that have previously avoided because of trauma-related distress. Participants assigned to the PE+ condition will receive the procedures noted above for the PE condition plus attendance-contingent financial incentives delivered immediately following completion of telemedicine-delivered PE sessions via a digital payment delivery platform.
- Conditions
- Opioid Use Disorder, Posttraumatic Stress Disorder
- Being tested
- Prolonged exposure therapy, Financial incentives, Treatment as usual
- Medical subject headings
- Opioid-Related Disorders, Stress Disorders, Post-Traumatic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Prolonged exposure therapyBehavioural
Twelve weekly 60-minute telemedicine-delivered prolonged exposure therapy sessions provided by therapists trained in prolonged exposure therapy.
Financial incentivesBehavioural
Financial incentives contingent upon completion of prolonged exposure therapy sessions
Treatment as usualBehavioural
Continued standard buprenorphine or methadone maintenance treatment from current treatment provider.
| Study group | Role | What they receive |
|---|---|---|
| Treatment as usual (TAU) | Active comparator | Participants randomized to TAU will continue to receive standard buprenorphine or methadone maintenance treatment from their current treatment provider and complete follow-up assessments as described above. However, they will not receive posttraumatic stress disorder treatment. Staff will mail participants an emergency naloxone kit containing two naloxone doses with simple instructions, a list of resources and contact information for mental health providers and other relevant resources in their community and assistance contacting any resources of interest. Receives: Behavioral: Treatment as usual |
| Prolonged exposure therapy (PE) | Experimental | In addition to receiving standard buprenorphine- or methadone-maintenance treatment from their current provider and completing scheduled assessments as described above, PE participants will also receive 12 individual sessions of prolonged exposure therapy scheduled weekly over the 12-week treatment period and delivered via a secure and university-supported telemedicine platform. Beginning in study week 1, PE participants will complete weekly 60-minute telemedicine-delivered prolonged exposure therapy sessions provided by doctoral or master's level therapists trained in prolonged exposure therapy. Receives: Behavioral: Prolonged exposure therapy; Behavioral: Treatment as usual |
| Prolonged exposure therapy + attendance contingent financial incentives (PE+) | Experimental | Participants assigned to the PE+ condition will receive the procedures noted above for the PE group plus financial incentives delivered contingent upon completion of PE sessions. Receives: Behavioral: Prolonged exposure therapy; Behavioral: Financial incentives; Behavioral: Treatment as usual |
What is being measured
The primary outcome is the main question the study is designed to answer.
Prolonged exposure therapy session attendance
Percentage of scheduled prolonged exposure therapy sessions attended
Measured: From baseline to week 12
Prolonged exposure therapy completion
Percentage of participants completing eight or more prolonged exposure therapy sessions
Measured: From baseline to week 12
Change in posttraumatic stress disorder symptom severity - clinician rated
Change in posttraumatic stress disorder symptom severity as measured by Clinician Administered PTSD Scale (CAPS-5) for clinician-rated posttraumatic stress symptoms. The CAPS-5 is a 30-item structured interview. CAPS-5 total symptom severity score is calculated by summing severity scores for the 20 PTSD symptoms, each with severity scores ranging from 0-4. The overall total severity score for CAPS-5 ranges from 0-80, with lower scores representing better outcomes (less severe PTSD).
Measured: From baseline to week 12
Secondary outcomes (8)
Change in non-prescribed drug use - objective
Change in non-prescribed drug use will be measured by the overall percentage of urine drug screens verified to be positive for non-prescribed opioids (e.g., heroin, methadone, buprenorphine, oxycodone, fentanyl) and non-opioid drugs (e.g., cocaine, amphetamines, benzodiazepines) during the treatment period.
Measured: From baseline to week 12 and 3, 6 months post-study
Change in non-prescribed drug use - self-reported
Time Line Follow Back (TLFB) to measure non-prescribed drug use.
Measured: From baseline to week 12 and 3, 6 months post-study
Change in opioid craving
Single item measure (range: 0-100) of craving for opioids.
Measured: From baseline to week 12
Medications for opioid use disorder treatment retention
Percentage of participants retained in medications for opioid use disorder treatment
Measured: From baseline to week 12 and 3, 6 months post-study
Prolonged exposure therapy acceptability
Treatment Acceptability/Adherence Scale to measure treatment acceptability
Measured: From baseline to week 12
Satisfaction with prolonged exposure therapy delivered via telemedicine
Telemedicine Satisfaction Questionnaire to measure satisfaction with treatment delivered via telemedicine
Measured: From baseline to week 12
Prolonged exposure therapy homework adherence
Homework adherence questionnaire to measure prolonged exposure therapy homework adherence
Measured: From baseline to week 12
Change in posttraumatic stress disorder symptom severity - self-reported
Change in posttraumatic stress disorder symptom severity as measured by PTSD Checklist for DSM-5 (PCL-5) for self-reported posttraumatic stress symptoms. The PCL-5 is a 20-item self-report measure that assesses the 20 symptoms of PTSD. The rating scale is 0-4 for each symptom/item, and overall scores range from 0-80, with lower scores representing better outcomes (less severe PTSD).
Measured: From baseline to week 12
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Mar 2024
- Study start3 Jun 2024
- Primary completion31 Aug 2027 (estimated)
- Study completion30 Nov 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Opioid Use DisorderStudies 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 135 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Vermont
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute on Drug Abuse (NIDA)
- Responsible party
- Principal investigator, Kelly Peck, University of Vermont
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06288711
- Sponsor's protocol ID
- CHRBSS #STUDY00002538
- Other IDs
- R01DA057308
- Status last verified
- May 2026
- First submitted
- 23 Feb 2024
- Last updated
- 18 May 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Novel Telemedicine-Delivered Prolonged Exposure Therapy for Treating PTSD in Individuals With OUD
- ClinicalTrials.gov ID
- NCT06288711
- Acronym / sponsor ID
- CHRBSS #STUDY00002538
- Conditions
- Opioid Use Disorder, Posttraumatic Stress Disorder
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 135 participants (estimated)
- Lead sponsor
- University of VermontUniversity, hospital or other
- Collaborators
- National Institute on Drug Abuse (NIDA)
- Study start
- 3 Jun 2024 (actual)
- Primary completion
- 31 Aug 2027 (estimated)
- Study completion
- 30 Nov 2027 (estimated)
- First posted
- 1 Mar 2024 (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.
Among individuals with opioid use disorder (OUD), posttraumatic stress disorder (PTSD) presents a significant clinical challenge. The prevalence of PTSD is substantially higher in individuals with OUD than in the general population, with nearly 90% reporting lifetime trauma exposure and 33% meeting diagnostic criteria for PTSD. The primary objective of this study is to evaluate the efficacy of a novel telemedicine-delivered prolonged exposure therapy protocol for improving PE attendance and reducing PTSD symptom severity in individuals with concurrent PTSD and OUD.
Detailed description
Nearly 90% of individuals with opioid use disorder (OUD) report lifetime trauma exposure and 33% meet criteria for posttraumatic stress disorder (PTSD). Patients with co-occurring PTSD and OUD are at significantly greater risk for poor substance use and mental health outcomes vs. those with OUD alone. Although Prolonged Exposure (PE) therapy is a first-line treatment for PTSD, its efficacy is commonly undermined by poor attendance.
The primary objective of this study is to evaluate the efficacy of a novel telemedicine-delivered prolonged exposure therapy protocol for improving PE attendance and reducing PTSD symptom severity in individuals with concurrent PTSD and OUD. In this randomized trial, adults with PTSD (N = 135) who are currently maintained on MOUD will be randomly assigned to one of three conditions: (a) Treatment as usual (TAU), (b) Prolonged exposure therapy (PE), or (c) Prolonged exposure therapy + attendance-contingent financial incentives (PE+). Participants randomized to the TAU condition will continue to receive standard MOUD treatment from their current treatment provider and complete remotely-administered assessments of PTSD symptoms, psychosocial functioning and drug use with an evaluator trained in the administration of all study measures and blinded to treatment condition at intake, monthly during the 12-week intervention, and at 3- and 6-months post-study, but will not receive PTSD treatment. In addition to receiving continued MOUD treatment from their current provider and completing assessments as above, participants assigned to PE will also receive telemedicine-delivered PE consisting of 12 weekly, individual sessions with trained master's- or doctoral-level therapists. PE sessions consist of imaginal exposure (i.e., revisiting and recounting traumatic memories) and processing the memory (i.e., discussing thoughts and feelings related to revisiting the memory). Participants also complete homework assignments consisting of repeated listening to a recording of the imaginal exposure and repeated in vivo exposure to safe situations that have previously avoided because of trauma-related distress. Participants assigned to the PE+ condition will receive the procedures noted above for the PE condition plus attendance-contingent financial incentives delivered immediately following completion of telemedicine-delivered PE sessions via a digital payment delivery platform.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Treatment as usual (TAU) | Active comparator | Behavioral: Treatment as usualParticipants randomized to TAU will continue to receive standard buprenorphine or methadone maintenance treatment from their current treatment provider and complete follow-up assessments as described above. However, they will not receive posttraumatic stress disorder treatment. Staff will mail participants an emergency naloxone kit containing two naloxone doses with simple instructions, a list of resources and contact information for mental health providers and other relevant resources in their community and assistance contacting any resources of interest. |
| Prolonged exposure therapy (PE) | Experimental | Behavioral: Prolonged exposure therapy, Behavioral: Treatment as usualIn addition to receiving standard buprenorphine- or methadone-maintenance treatment from their current provider and completing scheduled assessments as described above, PE participants will also receive 12 individual sessions of prolonged exposure therapy scheduled weekly over the 12-week treatment period and delivered via a secure and university-supported telemedicine platform. Beginning in study week 1, PE participants will complete weekly 60-minute telemedicine-delivered prolonged exposure therapy sessions provided by doctoral or master's level therapists trained in prolonged exposure therapy. |
| Prolonged exposure therapy + attendance contingent financial incentives (PE+) | Experimental | Behavioral: Prolonged exposure therapy, Behavioral: Financial incentives, Behavioral: Treatment as usualParticipants assigned to the PE+ condition will receive the procedures noted above for the PE group plus financial incentives delivered contingent upon completion of PE sessions. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- >18 years old
- Maintained on a stable methadone or buprenorphine dose for >1 month prior to the study
- Meet current DSM-5 posttraumatic stress disorder criteria based on the Clinician Administered PTSD Scale for DSM-5
- Participants receiving psychotropic medications must be maintained on a stable dose for >1 month prior to enrollment.
Key exclusion criteria (5 listed)
- Current delusions or hallucinations, unstable bipolar disorder, imminent risk for suicide as assessed by the Mini International Neuropsychiatric Interview
- Cognitive impairment as evidenced by scores <22 on the Videoconference-based Mini Mental Status Examination (MMSE; Folstein, et al., 1975)
- Enrolled in another ongoing evidence-based treatment for PTSD.
- Pregnancy as verified by pregnancy test
- No access to cellular service
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 |
|---|---|---|
| Prolonged exposure therapyTwelve weekly 60-minute telemedicine-delivered prolonged exposure therapy sessions provided by therapists trained in prolonged exposure therapy. | Behavioural | Prolonged exposure therapy (PE), Prolonged exposure therapy + attendance contingent financial incentives (PE+) |
| Financial incentivesFinancial incentives contingent upon completion of prolonged exposure therapy sessions | Behavioural | Prolonged exposure therapy + attendance contingent financial incentives (PE+) |
| Treatment as usualContinued standard buprenorphine or methadone maintenance treatment from current treatment provider. | Behavioural | Prolonged exposure therapy (PE), Prolonged exposure therapy + attendance contingent financial incentives (PE+), Treatment as usual (TAU) |
Primary outcome
Prolonged exposure therapy session attendance
Time frame: From baseline to week 12
Percentage of scheduled prolonged exposure therapy sessions attended
Prolonged exposure therapy completion
Time frame: From baseline to week 12
Percentage of participants completing eight or more prolonged exposure therapy sessions
Change in posttraumatic stress disorder symptom severity - clinician rated
Time frame: From baseline to week 12
Change in posttraumatic stress disorder symptom severity as measured by Clinician Administered PTSD Scale (CAPS-5) for clinician-rated posttraumatic stress symptoms. The CAPS-5 is a 30-item structured interview. CAPS-5 total symptom severity score is calculated by summing severity scores for the 20 PTSD symptoms, each with severity scores ranging from 0-4. The overall total severity score for CAPS-5 ranges from 0-80, with lower scores representing better outcomes (less severe PTSD).
8 secondary outcomes
Change in non-prescribed drug use - objective
Time frame: From baseline to week 12 and 3, 6 months post-study
Change in non-prescribed drug use - self-reported
Time frame: From baseline to week 12 and 3, 6 months post-study
Change in opioid craving
Time frame: From baseline to week 12
Medications for opioid use disorder treatment retention
Time frame: From baseline to week 12 and 3, 6 months post-study
Prolonged exposure therapy acceptability
Time frame: From baseline to week 12
Satisfaction with prolonged exposure therapy delivered via telemedicine
Time frame: From baseline to week 12
Prolonged exposure therapy homework adherence
Time frame: From baseline to week 12
Change in posttraumatic stress disorder symptom severity - self-reported
Time frame: From baseline to 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 18 May 2026.
- Individual participant dataSharing planned: No
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Prolonged exposure therapy, Financial incentives and Treatment as usual in people with Opioid Use Disorder and Posttraumatic Stress Disorder, run by University of Vermont 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 4 inclusion and 5 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: looking for participants now, as of the sponsor's last update on 18 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?
Contact Kelly Peck, Ph.D. (8026569610, Kelly.Peck@uvm.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Prolonged exposure therapy session attendance (time frame: From baseline to week 12). The study lists 3 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 18 May 2026.