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NCT04082637 · ClinicalTrials.gov registry record · NA
Mindful Body Awareness With Medication Treatment for Opioid Use Disorder
A NA study, sponsored by University of Washington.
- Completed
- Registry status
- NA
- Development phase
- 303
- Enrollment target
NCT04082637: Completed NA study, sponsored by University of Washington.
NCT04082637 is a NA study that has completed, run by University of Washington. The registered enrollment target is 303 participants, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (78% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT04082637, a NA study, has completed, sponsored by University of Washington.
- COMPLETED
- Registry status
- NA
- Development phase
- 303 participants
- Enrollment target
Study Summary
The national opioid epidemic requires development of real-world evidence-based treatments for opioid use disorder, including adjuncts to Medication for Opioid Use Disorder (MOUD). Interventions are needed that address the complex needs of patients with opioid use disorder, which include substantial mental health co-morbidity and high rates of chronic pain related to the complex interaction of opioid prescribing for pain and opioid use disorder. This study leverages recent federal and state opioid use disorder treatment initiatives as a platform for testing a promising mind-body intervention, Mindful Awareness in Body-oriented Therapy (MABT) as an adjunct to MOUD in multiple clinical settings funded primarily through the Washington Opioid State Targeted Response (STR) program. MABT, a novel mindfulness-based intervention, uniquely addresses aspects of awareness, interoception, and regulation that may be associated with pain, mental health distress, and behavioral control that increase risk of relapse and poor treatment outcomes. Using a randomized, two-group, repeated measures design, we will compare those who receive MABT+ MOUD vs. MOUD only. The overarching goal of this application is to test MABT to improve MOUD health outcomes. The specific aims for the combined R33/R01 clinical protocol are to: 1) evaluate the effectiveness of MABT + TAU (MOUD) compared to TAU only in reducing opioid use and other substances; 2) examine the effectiveness of MABT + TAU to improve mental and physical health vs. TAU only; 3) examine the effectiveness of MABT + TAU to positively affect substance use related outcomes of craving and treatment retention vs. TAU only. For the R01, there is an additional aim to explore the effectiveness of additional MABT dose offered at 6 months to those with continued substance use (non-responders) compared to those with continued substance use at 6 months in TAU. A two-group (n = 165/165), randomized controlled repeated measures design will be employe
Primary Outcome
Patient-reported days of opioid use and other substances
Interventions
- BEHAVIORAL Mindful Awareness in Body-oriented Therapy
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 303 participants |
| Start Date | 2019-08-14 |
| Est. Completion | 2024-03-01 |
| Phase | NA |
What the finished NCT04082637 record still lists
NCT04082637 is an interventional study that assigns participants to a tested intervention. The registered 303 participants enrollment target is mid-sized for trials with a published cap, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (78% lower).
The record links to 0 conditions, and to 1 intervention - of which Mindful Awareness in Body-oriented Therapy is the first listed.
NCT04082637 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT04082637 about?
NCT04082637 is a clinical study titled "Mindful Body Awareness With Medication Treatment for Opioid Use Disorder". The national opioid epidemic requires development of real-world evidence-based treatments for opioid use disorder, including adjuncts to Medication for Opioid Use Disorder (MOUD). Interventions are needed that address the complex needs of patients with opioid use disorder, which include substantial ...
What is the current status of trial NCT04082637?
This trial is currently completed. It is a NA study. The enrollment target is 303 participants. The study started on 2019-08-14. Estimated completion is 2024-03-01.
What interventions are being tested in trial NCT04082637?
The interventions under investigation include: Mindful Awareness in Body-oriented Therapy (BEHAVIORAL).
Who is sponsoring clinical trial NCT04082637?
This trial is sponsored by University of Washington, which has 1,048 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT04082637's enrollment target sits among peer trials
303 329th of 2000 higher than 1,671 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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