Opioid-use DisorderNCT04082637
Mindful Body Awareness With Medication Treatment for Opioid Use Disorder
A study testing Mindful Awareness in Body-oriented Therapy in people with Opioid-use Disorder, run by University of Washington at 5 sites in United States.
Trial 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). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Opioid-use Disorder
- What is being tested?
- Mindful Awareness in Body-oriented Therapy
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 303 participants
- Where
- 5 sitesUnited States
- Study dates
- 14 Aug 2019to 1 Mar 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- diagnosed with opioid use disorder
- enrolled in a medication treatment program for opioid use disorder
- is stable in program involving, (if on buprenorphine) Rx appointments less frequent than once/week; (if on methadone) at least 90 days in treatment with a minimum dose of 60mg, no missed dose evaluation appointments in past 30 days, and no more than 3 missed doses in 30 days
- willing to forego (non-study) manual (e.g., massage) and/or mind-body therapies (e.g., mindfulness meditation) for 3 months
- willing to sign release for access of electronic medical records
- fluent in English
- able to attend study sessions when offered
Who cannot join
- unwilling or unable to remain in MT treatment for the duration of the trial (includes planned relocation, pending incarceration, planned surgical procedures, etc.)
- over 24 weeks gestation or unknown gestation, if pregnant
- reports, or is noted by clinical or study staff as showing, overt psychosis or other conditions such as cognitive impairment
Trial locations and contacts
5 sites in 1 country.
5 sites in 1 country
United States5 sites
Cascade Medical Advantage
Bellingham, Washington, 98225
North Olympic Health Network
Port Angeles, Washington, 98362
Harborview Hospital
Seattle, Washington, 98104
Country Doctors Clinics
Seattle, Washington, 98122
Evergreen Treatment Services
Seattle, Washington, 98134
About this study
Official title: Mindful Body Awareness Training as an Adjunct to 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 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.
- Conditions
- Opioid-use Disorder
- Being tested
- Mindful Awareness in Body-oriented Therapy
- Keywords
- Buprenorphine, Medication-assisted treatment, Mind-body therapies, Mindfulness, Interoception, Mindful Awareness in Body-oriented Therapy
- Medical subject headings
- Opioid-Related Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Mindful Awareness in Body-oriented TherapyBehavioural
Also called MABT
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.
| Study group | Role | What they receive |
|---|---|---|
| MABT* + Medication Treatment | Experimental | Mindful Awareness in Body-oriented Therapy + Medication Treatment Receives: Behavioral: Mindful Awareness in Body-oriented Therapy |
| Treatment as Usual | No intervention | Treatment as Usual is medication for the treatment of opioid use disorder |
What is being measured
The primary outcome is the main question the study is designed to answer.
Time Line Follow-back
Patient-reported days of opioid use and other substances
Measured: 90 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Sep 2019
- Study start14 Aug 2019
- Primary completion30 Jan 2024
- Study completion1 Mar 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (7)Papers the sponsor has linked to this study.
- Other trials for Opioid-use DisorderStudies of the same condition, open and under way.
- More trials run by University of WashingtonThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 303 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Washington
- Sponsor type
- University, hospital or other
- Collaborators
- National Center for Complementary and Integrative Health (NCCIH)
- Responsible party
- Principal investigator, Cynthia Price, University of Washington
- Investigators
- Cynthia Price, PhD, Principal investigator, University of Washington
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04082637
- Sponsor's protocol ID
- STUDY00005923
- Other IDs
- R33AT009932, R21AT009932, R01AT010742
- Status last verified
- Jan 2025
- First submitted
- 3 Sep 2019
- Last updated
- 24 Jan 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Please see link below to access shared data, housed with ICPSR
Publications
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.
PubMed 31174929Leyde 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.
PubMed 38327009Rodriguez 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.
PubMed 38702783Price 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.
PubMed 39697819Price 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.
PubMed 40784065Price 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.
PubMed 39070653Rodriguez 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.
PubMed 38196650
Study at a glance
From the registry record, last updated by the sponsor on 24 Jan 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Mindful Body Awareness Training as an Adjunct to Medication Treatment for Opioid Use Disorder
- ClinicalTrials.gov ID
- NCT04082637
- Acronym / sponsor ID
- STUDY00005923
- Conditions
- Opioid-use Disorder
- Keywords
- Buprenorphine, Medication-assisted treatment, Mind-body therapies, Mindfulness, Interoception, Mindful Awareness in Body-oriented Therapy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 303 participants (actual)
- Lead sponsor
- University of WashingtonUniversity, hospital or other
- Collaborators
- National Center for Complementary and Integrative Health (NCCIH)
- Study start
- 14 Aug 2019 (actual)
- Primary completion
- 30 Jan 2024 (actual)
- Study completion
- 1 Mar 2024 (actual)
- First posted
- 9 Sep 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| MABT* + Medication Treatment | Experimental | Behavioral: Mindful Awareness in Body-oriented TherapyMindful Awareness in Body-oriented Therapy + Medication Treatment |
| Treatment as Usual | No intervention | –Treatment as Usual is medication for the treatment of opioid use disorder |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- diagnosed with opioid use disorder
- enrolled in a medication treatment program for opioid use disorder
- is stable in program involving, (if on buprenorphine) Rx appointments less frequent than once/week; (if on methadone) at least 90 days in treatment with a minimum dose of 60mg, no missed dose evaluation appointments in past 30 days, and no more than 3 missed doses in 30 days
- willing to forego (non-study) manual (e.g., massage) and/or mind-body therapies (e.g., mindfulness meditation) for 3 months
- willing to sign release for access of electronic medical records
Key exclusion criteria (3 listed)
- unwilling or unable to remain in MT treatment for the duration of the trial (includes planned relocation, pending incarceration, planned surgical procedures, etc.)
- over 24 weeks gestation or unknown gestation, if pregnant
- reports, or is noted by clinical or study staff as showing, overt psychosis or other conditions such as cognitive impairment
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Mindful Awareness in Body-oriented TherapyAlso: MABTA 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. | Behavioural | MABT* + Medication Treatment |
Primary outcome
Time Line Follow-back
Time frame: 90 days
Patient-reported days of opioid use and other substances
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Jan 2025.
- Results publication: PubMed 31174929Price 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.
- Results publication: PubMed 38327009Leyde 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.
- Results publication: PubMed 38702783Rodriguez 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.
- Results publication: PubMed 39697819Price 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.
- Derived from this study: PubMed 40784065Price 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.
- Derived from this study: PubMed 39070653Price 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.
- Derived from this study: PubMed 38196650Rodriguez 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.
- Individual participant dataSharing planned: Yes. Please see link below to access shared data, housed with ICPSR
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Cynthia Price, PhD principal investigator
University of Washington
5 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Mindful Awareness in Body-oriented Therapy in people with Opioid-use Disorder, run by University of Washington at 5 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 24 Jan 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 5 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Time Line Follow-back (time frame: 90 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04082637, which also lists 7 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Jan 2025.