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

Conditions

• Opioid Use Disorder
• Posttraumatic Stress Disorder

Eligibility Criteria

Sex

ALL

Age

18 Years - N/A

Healthy Volunteers

Not accepted

Interventions

• Prolonged exposure therapy — BEHAVIORAL
  Twelve weekly 60-minute telemedicine-delivered prolonged exposure therapy sessions provided by therapists trained in prolonged exposure therapy.
• Financial incentives — BEHAVIORAL
  Financial incentives contingent upon completion of prolonged exposure therapy sessions
• Treatment as usual — BEHAVIORAL
  Continued standard buprenorphine or methadone maintenance treatment from current treatment provider.

Study Details

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.

Key Dates

Start date

Jun 3, 2024

Status verified

May 2026

Primary completion

Aug 31, 2027

Completion

Nov 30, 2027

Study Design

Enrollment

135 participants (estimated)

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Arms

• 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.

Primary Outcome Measure

Prolonged exposure therapy session attendance [ Time Frame: From baseline to week 12 ]

Central Contacts

• Kelly Peck, Ph.D.
  8026569610
  [email protected]

Locations (1)

Find similar trials in Burlington, VT

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