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Behavioral Intervention

Prolonged exposure therapy + attendance contingent financial incentives (PE+) for Opioid Use Disorder

N/A
Recruiting
Research Sponsored by University of Vermont
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up from baseline to week 12 and 3, 6 months post-study
Awards & highlights

Study Summary

This trial aims to test a new therapy delivered through telemedicine to help individuals with opioid use disorder (OUD) and posttraumatic stress disorder (PTSD). PTSD is common in individuals with O

Who is the study for?
This trial is for adults over 18 with PTSD and OUD who have been on a stable methadone or buprenorphine dose for at least one month. They must meet the DSM-5 criteria for PTSD and if taking psychotropic meds, be on a stable dose for over a month.Check my eligibility
What is being tested?
The study tests telemedicine-delivered prolonged exposure therapy to see if it helps people with PTSD and OUD attend treatment sessions more regularly and reduce their PTSD symptoms compared to usual treatments plus financial incentives.See study design
What are the potential side effects?
Prolonged exposure therapy may cause temporary increases in distress due to recalling traumatic events, but this is part of the therapeutic process aimed at reducing long-term PTSD symptoms.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~from baseline to week 12 and 3, 6 months post-study
This trial's timeline: 3 weeks for screening, Varies for treatment, and from baseline to week 12 and 3, 6 months post-study for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Change in posttraumatic stress disorder symptom severity - clinician rated
Prolonged exposure therapy completion
Prolonged exposure therapy session attendance
Secondary outcome measures
Change in non-prescribed drug use - objective
Change in non-prescribed drug use - self-reported
Change in opioid craving
+5 more

Trial Design

3Treatment groups
Experimental Treatment
Active Control
Group I: Prolonged exposure therapy + attendance contingent financial incentives (PE+)Experimental Treatment3 Interventions
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.
Group II: Prolonged exposure therapy (PE)Experimental Treatment2 Interventions
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.
Group III: Treatment as usual (TAU)Active Control1 Intervention
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.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Treatment as usual
2010
N/A
~6760
Financial incentives
2018
Completed Phase 3
~26020
Prolonged exposure therapy
2009
N/A
~220

Find a Location

Who is running the clinical trial?

University of VermontLead Sponsor
268 Previous Clinical Trials
3,743,610 Total Patients Enrolled
National Institute on Drug Abuse (NIDA)NIH
2,472 Previous Clinical Trials
2,619,487 Total Patients Enrolled

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

What is the current number of individuals participating in this clinical study?

"Yes, information found on clinicaltrials.gov shows that this trial is presently in need of participants. The study was first listed on 30th April 2024 and the most recent update was made on 12th April 2024. A total of 135 patients are being sought from a single location."

Answered by AI

Are there any available openings for participation in this study at the moment?

"Indeed, information from clinicaltrials.gov indicates that this research is actively seeking volunteers. The trial was initially published on 30th April 2024 and the most recent update occurred on 12th April 2024. A total of 135 subjects are sought from a single site."

Answered by AI

What is the primary objective of conducting this clinical trial?

"The primary objective of this investigation, to be assessed between the commencement and week 12, is successful completion of prolonged exposure therapy. Secondary objectives encompass adherence to homework assignments in prolonged exposure therapy as per the Homework Adherence Questionnaire; alterations in self-reported posttraumatic stress disorder symptom severity examined through the PTSD Checklist for DSM-5 (PCL-5); and changes in self-reported non-prescribed drug utilization monitored by the Time Line Follow Back method."

Answered by AI

Who else is applying?

What site did they apply to?
University of Vemont
What portion of applicants met pre-screening criteria?
Met criteria
Recent research and studies
clinicaltrials.govStudy
Novel Telemedicine-Delivered Prolonged Exposure Therapy for Treating PTSD in Individuals With OUD
Kelly Peck 2024. "Novel Telemedicine-Delivered Prolonged Exposure Therapy for Treating PTSD in Individuals With OUD". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT06288711.
~90 spots leftby Aug 2027
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