NCT04082637

Mindful Body Awareness With Medication Treatment for Opioid Use Disorder

Completed NA Last updated 24 January 2025

What this trial tests

NA trial testing Mindful Awareness in Body-oriented Therapy in Opioid-use Disorder in 303 participants. Completed in 1 March 2024.

Timeline

14 August 2019

Primary endpoint
30 January 2024

1 March 2024

Quick facts

Lead sponsor	University of Washington
Phase	NA
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	single
Primary purpose	supportive care
Enrollment	303
Start date	14 August 2019
Primary completion	30 January 2024
Estimated completion	1 March 2024
Sites	5 locations across United States

Drugs / interventions tested

• Mindful Awareness in Body-oriented Therapy

Conditions studied

• Opioid-use Disorder — all drugs for Opioid-use Disorder →

Sponsor

University of Washington

Who can join

18 and older, any sex, with Opioid-use Disorder. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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 employed. Three hundred thirty individuals engaged in MOUD 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 MOUD and directly impact the future direction of the Washington Opioid STR program.

Publications & conference data

8 peer-reviewed publications reference this trial (live from Europe PMC):

1. Mindfulness-based interventions for substance use disorders.
   Goldberg SB, Pace B, Griskaitis M, Willutzki R, et al · · 2021 · cited 21× · PMID 34668188 · DOI 10.1002/14651858.cd011723.pub2
2. Adjunct interventions to standard medical management of buprenorphine in outpatient settings: A systematic review of the evidence.
   Wyse JJ, Morasco BJ, Dougherty J, Edwards B, et al · · 2021 · cited 19× · PMID 34508958 · DOI 10.1016/j.drugalcdep.2021.108923
3. Trauma exposure across the lifespan among individuals engaged in treatment with medication for opioid use disorder: differences by gender, PTSD status, and chronic pain.
   Rodríguez MN, Colgan DD, Leyde S, Pike K, et al · · 2024 · cited 12× · PMID 38702783 · DOI 10.1186/s13011-024-00608-8
4. Mental Health Distress Is Associated With Higher Pain Interference in Patients With Opioid Use Disorder Stabilized on Buprenorphine or Methadone.
   Leyde S, Price CJ, Colgan DD, Pike KC, et al · · 2024 · cited 8× · PMID 38327009 · DOI 10.1177/29767342241227402
5. Immediate Effects of Mindful Awareness in Body-Oriented Therapy as an Adjunct to Medication for Opioid Use Disorder.
   Price CJ, Pike KC, Treadway A, Palmer JK, et al · · 2024 · cited 7× · PMID 39697819 · DOI 10.1007/s12671-024-02463-x
6. Longitudinal effects of interoceptive awareness training as an adjunct to medication treatment for opioid use disorder: A randomized clinical trial of Mindful Awareness in Body-oriented Therapy.
   Price CJ, Pike KC, Merrill JO. · · 2025 · cited 1× · PMID 40784065 · DOI 10.1016/j.drugalcdep.2025.112813
7. Immediate Effects of Mindful Awareness in Body-oriented Therapy as an Adjunct to Medication for Opioid Use Disorder
   Price CU, Pike KC, Treadway A, Palmer J, et al · · 2024 · DOI 10.21203/rs.3.rs-4727162/v1
8. Trauma Exposure Across the Lifespan among Individuals Engaged in Treatment with Medication for Opioid Use Disorder: Differences by Gender, PTSD Status, and Chronic Pain
   Rodríguez MN, Colgan DD, Leyde S, Pike K, et al · · 2023 · DOI 10.21203/rs.3.rs-3750143/v1