NCT06288711 Novel Telemedicine-Delivered Prolonged Exposure Therapy for Treating PTSD in Individuals With OUD
| NCT ID | NCT06288711 |
| Status | Recruiting |
| Phase | — |
| Sponsor | University of Vermont |
| Condition | Opioid Use Disorder |
| Study Type | INTERVENTIONAL |
| Enrollment | 135 participants |
| Start Date | 2024-06-03 |
| Primary Completion | 2027-08-31 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 135 participants in total. It began in 2024-06-03 with a primary completion date of 2027-08-31.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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 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.
Eligibility Criteria
Inclusion Criteria: * \>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. Exclusion Criteria: * 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
Contact & Investigator
Frequently Asked Questions
Who can join the NCT06288711 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Opioid Use Disorder. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT06288711 currently recruiting?
Yes, NCT06288711 is actively recruiting participants. Contact the research team at Kelly.Peck@uvm.edu for enrollment information.
Where is the NCT06288711 trial being conducted?
This trial is being conducted at Burlington, United States.
Who is sponsoring the NCT06288711 clinical trial?
NCT06288711 is sponsored by University of Vermont. The trial plans to enroll 135 participants.