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NCT04760418 · ClinicalTrials.gov registry record · NA

Trauma and Trauma-Focused Therapy in the University of Kentucky SMART Clinic

A NA study, sponsored by Christal L Badour.

Completed
Registry status
NA
Development phase
21
Enrollment target

NCT04760418: Completed NA study, sponsored by Christal L Badour.

NCT04760418 is a NA study that has completed, run by Christal L Badour. The registered enrollment target is 21 participants, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (99% lower). According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT04760418, a NA study, has completed, sponsored by Christal L Badour.

COMPLETED
Registry status
NA
Development phase
21 participants
Enrollment target

Study Summary

Opioid misuse is a national public health epidemic. More than 130 people in the United States die each day following an opioid overdose, and over 2 million people meet criteria for an opioid use disorder (OUD). Medication-assisted treatment (MAT), which involves use of medication (buprenorphine, methadone, naltrexone) in combination with behavioral therapy or counseling, is the most effective intervention for OUD. Yet, MAT remains less than optimally effective, particularly for patients with psychiatric comorbidity \[6\]. Novel approaches are needed to improve long-term outcomes for OUD patients. Psychological trauma and posttraumatic stress disorder (PTSD) are highly prevalent among individuals with OUD. Over 90% of adults with OUD report a lifetime history of trauma. Among OUD patients engaged in MAT, nearly 20% report experiencing at least one new traumatic event each month, and nearly a third meet criteria for a co-occurring diagnosis of posttraumatic stress disorder (PTSD). Several studies have linked new incidents of trauma as well as the presence of PTSD to poorer MAT engagement and poorer treatment outcomes, including treatment interruption and premature dropout. Preliminary evidence suggests that engaging in trauma-focused treatment for PTSD concurrent with MAT may result in better long-term adherence to medication for OUD. However, recent evidence finds that fewer than half of patients with PTSD in MAT receive any trauma-focused treatment, and even fewer receive evidence-based interventions. Trauma-focused treatments that concurrently address symptoms of PTSD and substance abuse using an integrated approach have been recommended over traditional substance abuse interventions for patients with this complex dual diagnosis presentation. Concurrent Treatment of PTSD and Substance Use Disorders Using Prolonged Exposure (COPE) is a 12-session evidence-based cognitive-behavioral therapy that integrates exposure therapy for PTSD with cognitive-behavioral skills

Primary Outcome

Change in Posttraumatic Stress Disorder Symptom Severity

Interventions

  • BEHAVIORAL Concurrent Treatment of PTSD and Substance Use Disorders Using Prolonged Exposure (COPE)

Trial Details

FieldValue
Enrollment Target 21 participants
Start Date 2021-05-26
Est. Completion 2022-02-17
Phase NA
Christal L Badour

3 total trials

What the finished NCT04760418 record still lists

NCT04760418 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 21 participants, a relatively small participant target, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (99% lower).

The record links to 0 conditions, and to 1 intervention - of which Concurrent Treatment of PTSD and Substance Use Disorders Using Prolonged Exposure (COPE) is the first listed.

NCT04760418 does not publish any study locations in the registry export this page uses.

Frequently Asked Questions

What is clinical trial NCT04760418 about?

NCT04760418 is a clinical study titled "Trauma and Trauma-Focused Therapy in the University of Kentucky SMART Clinic". Opioid misuse is a national public health epidemic. More than 130 people in the United States die each day following an opioid overdose, and over 2 million people meet criteria for an opioid use disorder (OUD). Medication-assisted treatment (MAT), which involves use of medication (buprenorphine, met...

What is the current status of trial NCT04760418?

This trial is currently completed. It is a NA study. The enrollment target is 21 participants. The study started on 2021-05-26. Estimated completion is 2022-02-17.

What interventions are being tested in trial NCT04760418?

The interventions under investigation include: Concurrent Treatment of PTSD and Substance Use Disorders Using Prolonged Exposure (COPE) (BEHAVIORAL).

Who is sponsoring clinical trial NCT04760418?

This trial is sponsored by Christal L Badour, which has 3 total clinical trials registered on ClinicalTrials.gov.

How this trial's enrollment target compares

Where NCT04760418's enrollment target sits among peer trials

21 1762nd of 2000 higher than 233 of 2,000 other NA trials

participants (enrollment target), bucketed by value

Each bar is a band; taller bars hold more other NA trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.

Source ClinicalTrials.gov registry export · 2026-08-08

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Source: ClinicalTrials.gov NCT04760418, the US trial registry maintained by the National Library of Medicine. NCT04760418 (small enrollment · none site footprint · completed) retrieved and formatted by PlainTrial, see methodology.