Skip to main content
OpenTrials
Recruiting

NCT Number: NCT06288711

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

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.

Recruiting

Interested in participating?

Request Info

Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of Vemont

Burlington, Vermont, 05401, United States

Location status: Recruiting

Location contact

Kelly R Peck, Ph.D.

CONTACT

[email protected]

8026569610

About this study

Nearly 90% of individuals with opioid use disorder (OUD) report lifetime trauma exposure and 33% meet criteria for posttraumatic stress disorder (PTSD). Patients with co-occurring PTSD and OUD are at significantly greater risk for poor substance use and mental health outcomes vs. those with OUD alone. Although Prolonged Exposure (PE) therapy is a first-line treatment for PTSD, its efficacy is commonly undermined by poor attendance.

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. In this randomized trial, adults with PTSD (N = 135) who are currently maintained on MOUD will be randomly assigned to one of three conditions: (a) Treatment as usual (TAU), (b) Prolonged exposure therapy (PE), or (c) Prolonged exposure therapy + attendance-contingent financial incentives (PE+). Participants randomized to the TAU condition will continue to receive standard MOUD treatment from their current treatment provider and complete remotely-administered assessments of PTSD symptoms, psychosocial functioning and drug use with an evaluator trained in the administration of all study measures and blinded to treatment condition at intake, monthly during the 12-week intervention, and at 3- and 6-months post-study, but will not receive PTSD treatment. In addition to receiving continued MOUD treatment from their current provider and completing assessments as above, participants assigned to PE will also receive telemedicine-delivered PE consisting of 12 weekly, individual sessions with trained master's- or doctoral-level therapists. PE sessions consist of imaginal exposure (i.e., revisiting and recounting traumatic memories) and processing the memory (i.e., discussing thoughts and feelings related to revisiting the memory). Participants also complete homework assignments consisting of repeated listening to a recording of the imaginal exposure and repeated in vivo exposure to safe situations that have previously avoided because of trauma-related distress. Participants assigned to the PE+ condition will receive the procedures noted above for the PE condition plus attendance-contingent financial incentives delivered immediately following completion of telemedicine-delivered PE sessions via a digital payment delivery platform.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

Primary outcomes

  1. Prolonged exposure therapy session attendance

    Time frame: From baseline to week 12

    Percentage of scheduled prolonged exposure therapy sessions attended

  2. Prolonged exposure therapy completion

    Time frame: From baseline to week 12

    Percentage of participants completing eight or more prolonged exposure therapy sessions

  3. Change in posttraumatic stress disorder symptom severity - clinician rated

    Time frame: From baseline to week 12

    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).

Secondary outcomes

  1. Change in non-prescribed drug use - objective

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

    Change in non-prescribed drug use will be measured by the overall percentage of urine drug screens verified to be positive for non-prescribed opioids (e.g., heroin, methadone, buprenorphine, oxycodone, fentanyl) and non-opioid drugs (e.g., cocaine, amphetamines, benzodiazepines) during the treatment period.

  2. Change in non-prescribed drug use - self-reported

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

    Time Line Follow Back (TLFB) to measure non-prescribed drug use.

  3. Change in opioid craving

    Time frame: From baseline to week 12

    Single item measure (range: 0-100) of craving for opioids.

  4. Medications for opioid use disorder treatment retention

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

    Percentage of participants retained in medications for opioid use disorder treatment

  5. Prolonged exposure therapy acceptability

    Time frame: From baseline to week 12

    Treatment Acceptability/Adherence Scale to measure treatment acceptability

  6. Satisfaction with prolonged exposure therapy delivered via telemedicine

    Time frame: From baseline to week 12

    Telemedicine Satisfaction Questionnaire to measure satisfaction with treatment delivered via telemedicine

  7. Prolonged exposure therapy homework adherence

    Time frame: From baseline to week 12

    Homework adherence questionnaire to measure prolonged exposure therapy homework adherence

  8. Change in posttraumatic stress disorder symptom severity - self-reported

    Time frame: From baseline to week 12

    Change in posttraumatic stress disorder symptom severity as measured by PTSD Checklist for DSM-5 (PCL-5) for self-reported posttraumatic stress symptoms. The PCL-5 is a 20-item self-report measure that assesses the 20 symptoms of PTSD. The rating scale is 0-4 for each symptom/item, and overall scores range from 0-80, with lower scores representing better outcomes (less severe PTSD).

Study contacts

Contact information is provided by the study sponsor or research team.

Kelly Peck, Ph.D.

CONTACT

[email protected]

8026569610

Sponsors and collaborators

Lead sponsor

University of Vermont

Other

Collaborators

  • National Institute on Drug Abuse (NIDA)

Registry information

Important dates

Study start
2024
Primary completion
2027
Study completion
2027
First posted
Mar 1, 2024
Registry last updated
May 18, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.