Telemedicine therapy for PTSD in people with opioid use disorder
Novel Telemedicine-Delivered Prolonged Exposure Therapy for Treating PTSD in Individuals With OUD
NA · University of Vermont · NCT06288711
This study is testing a new telemedicine therapy for people with opioid use disorder and PTSD to see if it helps them feel better and stick with their treatment.
Quick facts
| Phase | NA |
|---|---|
| Study type | Interventional |
| Enrollment | 135 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | University of Vermont (other) |
| Locations | 1 site (Burlington, Vermont) |
| Trial ID | NCT06288711 on ClinicalTrials.gov |
What this trial studies
This study evaluates a novel telemedicine-delivered prolonged exposure therapy aimed at improving attendance and reducing PTSD symptoms in individuals with opioid use disorder (OUD) who also have PTSD. Participants will be randomly assigned to one of three groups: treatment as usual, prolonged exposure therapy, or prolonged exposure therapy with financial incentives for attendance. The study will involve remote assessments of PTSD symptoms and psychosocial functioning over a 12-week intervention period, followed by follow-up assessments at 3 and 6 months. The goal is to address the high prevalence of PTSD among those with OUD and improve treatment outcomes.
Who should consider this trial
Good fit: Ideal candidates are adults over 18 who are stable on methadone or buprenorphine and meet criteria for PTSD.
Not a fit: Patients with current delusions, hallucinations, unstable bipolar disorder, or those enrolled in other PTSD treatments may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could significantly improve PTSD treatment attendance and reduce symptoms in individuals with co-occurring opioid use disorder.
How similar studies have performed: Other studies have shown promise in using telemedicine for mental health treatment, but this specific approach is novel.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
Burlington, Vermont
- University of Vemont — Burlington, Vermont, United States (RECRUITING)
Study contacts
- Study coordinator: Kelly Peck, Ph.D.
- Email: Kelly.Peck@uvm.edu
- Phone: 8026569610
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Opioid Use Disorder, Posttraumatic Stress Disorder