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

NCT06288711 | Recruiting DMC

• 2 other identifiers: CHRBSS #STUDY00002538R01DA057308
• Study Type: interventional
• Target: 135
• Locations: 1 country
• Sites: 1

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.

Conditions

Opioid Use Disorder; Posttraumatic Stress Disorder

Outcome Measures

Primary Outcomes (3)

• Prolonged exposure therapy session attendance

  Percentage of scheduled prolonged exposure therapy sessions attended

  From baseline to week 12

• Prolonged exposure therapy completion

  Percentage of participants completing eight or more prolonged exposure therapy sessions

  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).

  From baseline to week 12

Secondary Outcomes (8)

• Change in non-prescribed drug use - objective

  From baseline to week 12 and 3, 6 months post-study

• Change in non-prescribed drug use - self-reported

  From baseline to week 12 and 3, 6 months post-study

• Change in opioid craving

  From baseline to week 12

• Medications for opioid use disorder treatment retention

  From baseline to week 12 and 3, 6 months post-study

• Prolonged exposure therapy acceptability

  From baseline to week 12

Study Arms (3)

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.

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.

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.

Behavioral: Prolonged exposure therapy; Behavioral: Financial incentives; Behavioral: Treatment as usual

Interventions

Prolonged exposure therapy BEHAVIORAL

Twelve weekly 60-minute telemedicine-delivered prolonged exposure therapy sessions provided by therapists trained in prolonged exposure therapy.

Prolonged exposure therapy (PE); Prolonged exposure therapy + attendance contingent financial incentives (PE+)

Financial incentives BEHAVIORAL

Financial incentives contingent upon completion of prolonged exposure therapy sessions

Prolonged exposure therapy + attendance contingent financial incentives (PE+)

Treatment as usual BEHAVIORAL

Continued standard buprenorphine or methadone maintenance treatment from current treatment provider.

Prolonged exposure therapy (PE); Prolonged exposure therapy + attendance contingent financial incentives (PE+); Treatment as usual (TAU)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• \>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.

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Vermont: lead
• National Institute on Drug Abuse (NIDA): collaborator

Study Sites (1)

University of Vemont

Burlington, Vermont, 05401, United States

RECRUITING

MeSH Terms

Conditions

Opioid-Related Disorders; Stress Disorders, Post-Traumatic

Interventions

Therapeutics

Condition Hierarchy (Ancestors)

Narcotic-Related Disorders; Substance-Related Disorders; Chemically-Induced Disorders; Mental Disorders; Stress Disorders, Traumatic; Trauma and Stressor Related Disorders

Central Study Contacts

Kelly Peck, Ph.D.

CONTACT

8026569610; Kelly.Peck@uvm.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Study Record Dates

• First Submitted: February 23, 2024
• First Posted: March 1, 2024
• Study Start: June 3, 2024
• Primary Completion (Estimated): August 31, 2027
• Study Completion (Estimated): November 30, 2027
• Last Updated: April 13, 2025

Record last verified: 2025-04

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)