Not provided
| ID | Type | Description | Link |
|---|---|---|---|
| R33AT009932 | U.S. NIH Grant/Contract | View source | |
| R21AT009932 | U.S. NIH Grant/Contract | View source | |
| R01AT010742 | U.S. NIH Grant/Contract | View source |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Class |
|---|---|
| National Center for Complementary and Integrative Health (NCCIH) | NIH |
Not provided
Not provided
Not provided
Not provided
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.
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| MABT* + Medication Treatment | Experimental | Mindful Awareness in Body-oriented Therapy + Medication Treatment |
|
| Treatment as Usual | No Intervention | Treatment as Usual is medication for the treatment of opioid use disorder |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Mindful Awareness in Body-oriented Therapy | Behavioral | A mind-body intervention designed to teach interoceptive awareness skills for emotion regulation and self-care. Delivered individually in 75 minute sessions once a week for 8 weeks. |
| Measure | Description | Time Frame |
|---|---|---|
| Time Line Follow-back | Patient-reported days of opioid use and other substances | 90 days |
Not provided
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Cynthia Price, PhD | University of Washington | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Cascade Medical Advantage | Bellingham | Washington | 98225 | United States | ||
| North Olympic Health Network |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 31174929 | Result | Price CJ, Merrill JO, McCarty RL, Pike KC, Tsui JI. A pilot study of mindful body awareness training as an adjunct to office-based medication treatment of opioid use disorder. J Subst Abuse Treat. 2020 Jan;108:123-128. doi: 10.1016/j.jsat.2019.05.013. Epub 2019 May 23. | |
| 38327009 | Result | Leyde S, Price CJ, Colgan DD, Pike KC, Tsui JI, Merrill JO. Mental Health Distress Is Associated With Higher Pain Interference in Patients With Opioid Use Disorder Stabilized on Buprenorphine or Methadone. Subst Use Addctn J. 2024 Jul;45(3):423-433. doi: 10.1177/29767342241227402. Epub 2024 Feb 7. |
Not provided
Not provided
Please see link below to access shared data, housed with ICPSR
currently available with no time limit
apply to ICPSR for access
| Type | Date | Date Unknown |
|---|---|---|
| Release | Apr 27, 2026 | |
| Reset | May 19, 2026 |
Not provided
| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Oct 20, 2021 | Jan 21, 2025 | Prot_SAP_001.pdf |
| ICF | No | No | Yes | Informed Consent Form | Jan 5, 2021 | Nov 26, 2024 | ICF_000.pdf |
Not provided
Not provided
| Release Date | Unrelease Date | Unrelease Date Unknown | Reset Date | MCP Release Number |
|---|---|---|---|---|
| Apr 27, 2026 | May 19, 2026 |
| ID | Term |
|---|---|
| D009293 | Opioid-Related Disorders |
| ID | Term |
|---|---|
| D000079524 | Narcotic-Related Disorders |
| D019966 | Substance-Related Disorders |
| D064419 | Chemically-Induced Disorders |
| D001523 | Mental Disorders |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
|
| Port Angeles |
| Washington |
| 98362 |
| United States |
| Harborview Hospital | Seattle | Washington | 98104 | United States |
| Country Doctors Clinics | Seattle | Washington | 98122 | United States |
| Evergreen Treatment Services | Seattle | Washington | 98134 | United States |
| 38702783 | Result | Rodriguez MN, Colgan DD, Leyde S, Pike K, Merrill JO, Price CJ. Trauma exposure across the lifespan among individuals engaged in treatment with medication for opioid use disorder: differences by gender, PTSD status, and chronic pain. Subst Abuse Treat Prev Policy. 2024 May 3;19(1):25. doi: 10.1186/s13011-024-00608-8. |
| 39697819 | Result | Price CJ, Pike KC, Treadway A, Palmer JK, Merrill JO. Immediate Effects of Mindful Awareness in Body-Oriented Therapy as an Adjunct to Medication for Opioid Use Disorder. Mindfulness (N Y). 2024 Nov;15(11):2794-2811. doi: 10.1007/s12671-024-02463-x. Epub 2024 Nov 19. |
| 40784065 | Derived | Price CJ, Pike KC, Merrill JO. 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. Drug Alcohol Depend. 2025 Oct 1;275:112813. doi: 10.1016/j.drugalcdep.2025.112813. Epub 2025 Aug 5. |
| 39070653 | Derived | Price CU, Pike KC, Treadway A, Palmer J, Merrill JO. Immediate Effects of Mindful Awareness in Body-oriented Therapy as an Adjunct to Medication for Opioid Use Disorder. Res Sq [Preprint]. 2024 Jul 15:rs.3.rs-4727162. doi: 10.21203/rs.3.rs-4727162/v1. |
| 38196650 | Derived | Rodriguez MN, Colgan DD, Leyde S, Pike K, Merrill JO, Price CJ. Trauma Exposure Across the Lifespan among Individuals Engaged in Treatment with Medication for Opioid Use Disorder: Differences by Gender, PTSD Status, and Chronic Pain. Res Sq [Preprint]. 2023 Dec 19:rs.3.rs-3750143. doi: 10.21203/rs.3.rs-3750143/v1. |