Novel Telemedicine-Delivered Prolonged Exposure Therapy for Treating PTSD in Individuals With OUD

Status: Recruiting
Location: See location...
Intervention Type: Behavioral
Study Type: Interventional
Study Phase: Not Applicable
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
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

• \>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.

Locations
United States
Vermont
University of Vemont
RECRUITING
Burlington
Contact Information
Primary
Kelly Peck, Ph.D.
Kelly.Peck@uvm.edu
8026569610
Time Frame
Start Date: 2024-06-03
Estimated Completion Date: 2027-11-30
Participants
Target number of participants: 135
Treatments
Active_comparator: Treatment as usual (TAU)
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.
Experimental: Prolonged exposure therapy (PE)
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.
Experimental: Prolonged exposure therapy + attendance contingent financial incentives (PE+)
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.
Related Therapeutic Areas
Sponsors
Collaborators: National Institute on Drug Abuse (NIDA)
Leads: University of Vermont

This content was sourced from clinicaltrials.gov

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