Mindful Body Awareness With Medication Treatment for Opioid Use Disorder
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- STATUS
- Recruiting
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- End date
- Aug 2, 2023
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- participants needed
- 330
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- sponsor
- University of Washington
Summary
The national opioid epidemic requires development of real-world evidence-based treatments for opioid use disorder, including adjuncts to Medication Treatment (MT). 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 MT 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+ MTT to MT only. The overarching goal of this application is to test MABT to improve MT health outcomes among patients receiving MTto treat OUD. The specific aims for the combined R33/R01 clinical protocol are to: 1) evaluate the effectiveness of MABT + TAU compared to TAU only in reducing opioid use (OU) and other illicit 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 employed. Three hundred thirty individuals with OUD engaged in buprenorphine treatment will be recruited for participation at outpatient treatment sites. Assessments will be administered at baseline, post-intervention (3 months from baseline), and at 6, 9, and 12 months. Results of this study will inform the evidence base for behavioral treatment adjuncts to MT and directly impact the future direction of the Washington Opioid STR program.
Details
| Condition | Opioid Use Disorder |
|---|---|
| Treatment | Mindful Awareness in body-oriented therapy |
| Clinical Study Identifier | NCT04082637 |
| Sponsor | University of Washington |
| Last Modified on | 17 November 2021 |
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