Opioid UseYOGAMAT-IINCT04641221

Optimization and Multi-Site Feasibility of Yoga for Chronic Pain in People in YOGAMAT-II - Phase II

A study testing Weekly Yoga Classes in people with Opioid Use and Chronic Pain, run by Butler Hospital at 2 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

Phase 2 - Multiphase Optimization Strategy (MOST) Optimization Phase: 1. To conduct a factorial experiment that will allow us to evaluate the impact of each of the 4 intervention components on yoga dosage received. We will enroll a total n=192. Read more about this study

Who is it for?: Ages 18 years and older
Conditions the study is for: Opioid Use, Chronic Pain
What is being tested?: Weekly Yoga Classes
Type of treatment: Lifestyle or therapy programme
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 192 participants
Where: 2 sitesUnited States
Study dates: 20 Feb 2022to 31 Aug 2025
Phase: Interventional
Are there results?: Yes, posted in the registrySummary in the doctors' view

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

Enrolled in MMT or BUP treatment for > 3 months
Plan to continue treatment for next 6 months
Chronic pain, defined as pain for at least half the days over the previous three months, a mean score of 4 or higher on the Brief Pain Interference Scale (BPI; with reference to chronic pain), and pain severity of 4 or higher on a Visual Analog Scale (0-10) indicating "worst pain in the last week." Pain severity score will also refer to the areas of their body in which they have chronic pain.
Aged > 18
Proficiency in English sufficient to engage in informed consent in English, understand classes taught in English, and read short sentences
Available at least one of the times study classes are offered.

Who cannot join

Currently taking yoga classes or practicing yoga at home once per week or more often.
Medical conditions that would make participation in yoga unsafe or not possible, including active malignancy treatment, fracture, recent joint surgery, use of assistive ambulatory devices other than a cane. . (In cases where this is unclear, site PI will make final determination based on available evidence.)
Severe or progressive neurologic deficits. (In cases where this is unclear, site PI will make final determination based on available evidence.)
Other severe disabling chronic medical and/or psychiatric comorbidities deemed by the site PI on a case-by-case basis to prevent safe or adequate participation in the study (e.g., cognitive impairment that prevents a participant from understanding assessments; history of disruptive behavior in medical settings; severe disabling heart failure or lung disease)
Surgery requiring overnight hospitalization planned in the next 3 months
Pregnancy
No access to a reasonably safe, reliable place to engage in personal yoga practice and a private space to participate in online yoga classes

Trial locations and contacts

2 sites in 1 country.

United States2 sites

Boston Medical Center
Boston, Massachusetts, 02118
CODAC Behavioral Healthcare
Providence, Rhode Island, 02909

Other trials in United States

About this study

Phase 2 - Multiphase Optimization Strategy (MOST) Optimization Phase:

To conduct a factorial experiment that will allow us to evaluate the impact of each of the 4 intervention components on yoga dosage received. We will enroll a total n=192. All participants will receive the core yoga intervention, with random assignment to the four intervention components outlined above.
Use results from Phase 2 to choose an efficient combination of intervention components that, together with standard yoga classes, maximizes yoga dosage.
Examine mechanisms by which components are hypothesized to work.

Read the detailed description

In Phase 2, we will conduct a fully powered optimization trial. We will enroll 192 participants, planning to role approximately equal numbers of participants in both sites. In both phases, all participants will receive the core yoga intervention (12 weeks of weekly manualized yoga classes), with random assignment to the 4 key intervention components. Participants will be patients enrolled in methadone (MMT) or buprenorphine/naloxone (BUP) treatment with chronic pain. Enrollment period for this phase will last approximately 2 years.

Conditions: Opioid Use, Chronic Pain
Being tested: Weekly Yoga Classes
Medical subject headings: Chronic Pain

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Weekly Yoga ClassesBehavioural
All participants are invited to attend weekly yoga classes.

Study groups in NCT04641221
Study group	Role	What they receive
No Video/No One-on-One/No Text/No Incentive	Active comparator	This group does not receive Personal Practice Videos, or One-on-One individual sessions with a Yoga Instructor, or prompting Text messages, or financial Incentives to attend yoga classes Receives: Behavioral: Weekly Yoga Classes
No Video/No One-on-One/No Text/Yes Incentive	Active comparator	This group does not receive Personal Practice Videos, or One-on-One individual sessions with a Yoga Instructor, or prompting Text messages, but DOES receive financial Incentives to attend yoga classes Receives: Behavioral: Weekly Yoga Classes
No Video/No One-on-One/Yes Text/No Incentive	Active comparator	This group does not receive Personal Practice Videos, or One-on-One individual sessions with a Yoga Instructor, or financial Incentives to attend yoga classes, but DOES receive prompting Text messages Receives: Behavioral: Weekly Yoga Classes
No Video/No One-on-One/Yes Text/Yes Incentive	Active comparator	This group does not receive Personal Practice Videos, or One-on-One individual sessions with a Yoga Instructor, but DOES receive prompting Text messages and financial Incentives to attend yoga classes Receives: Behavioral: Weekly Yoga Classes
No Video/Yes One-on-One/No Text/No Incentive	Active comparator	This group does not receive Personal Practice Videos or prompting Text messages or financial Incentives to attend yoga classes, but DOES receive One-on-One individual sessions with a Yoga Instructor Receives: Behavioral: Weekly Yoga Classes
No Video/Yes One-on-One/No Text/Yes Incentive	Active comparator	This group does not receive Personal Practice Videos or prompting Text messages, but DOES receive One-on-One individual sessions with a Yoga Instructor, and financial Incentives to attend yoga classes Receives: Behavioral: Weekly Yoga Classes
No Video/Yes One-on-One/Yes Text/No Incentive	Active comparator	This group does not receive Personal Practice Videos or financial Incentives to attend yoga classes, but DOES receive One-on-One individual sessions with a Yoga Instructor and prompting Text messages Receives: Behavioral: Weekly Yoga Classes
No Video/Yes One-on-One/Yes Text/Yes Incentive	Active comparator	This group does not receive Personal Practice Videos, but DOES receive One-on-One individual sessions with a Yoga Instructor, prompting Text messages, and financial Incentives to attend yoga classes Receives: Behavioral: Weekly Yoga Classes
Yes Video/No One-on-One/No Text/No Incentive	Active comparator	This group does not receive One-on-One individual sessions with a Yoga Instructor, or prompting Text messages, or financial Incentives to attend yoga classes, but DOES receive Personal Practice Videos Receives: Behavioral: Weekly Yoga Classes
Yes Video/No One-on-One/No Text/Yes Incentive	Active comparator	This group does not receive One-on-One individual sessions with a Yoga Instructor or prompting Text messages, but DOES receive Personal Practice Videos and financial Incentives to attend yoga classes Receives: Behavioral: Weekly Yoga Classes
Yes Video/No One-on-One/Yes Text/No Incentive	Active comparator	This group does not receive One-on-One individual sessions with a Yoga Instructor or financial Incentives to attend yoga classes, but DOES receive Personal Practice Videos and prompting Text messages Receives: Behavioral: Weekly Yoga Classes
Yes Video/No One-on-One/Yes Text/Yes Incentive	Active comparator	This group does not receive One-on-One individual sessions with a Yoga Instructor, but DOES receive Personal Practice Videos, prompting Text messages, and financial Incentives to attend yoga classes Receives: Behavioral: Weekly Yoga Classes
Yes Video/Yes One-on-One/No Text/No Incentive	Active comparator	This group does not receive prompting Text messages or financial Incentives to attend yoga classes, but DOES receive Personal Practice Videos and One-on-One individual sessions with a Yoga Instructor Receives: Behavioral: Weekly Yoga Classes
Yes Video/Yes One-on-One/No Text/Yes Incentive	Active comparator	This group does not receive prompting Text messages, but DOES receive Personal Practice Videos, One-on-One individual sessions with a Yoga Instructor, and financial Incentives to attend yoga classes Receives: Behavioral: Weekly Yoga Classes
Yes Video/Yes One-on-One/Yes Text/No Incentive	Active comparator	This group does not receive financial Incentives to attend yoga classes, but DOES receive Personal Practice Videos, One-on-One individual sessions with a Yoga Instructor and prompting Text messages Receives: Behavioral: Weekly Yoga Classes
Yes Video/Yes One-on-One/Yes Text/Yes Incentive	Active comparator	This group receives Personal Practice Videos, One-on-One individual sessions with a Yoga Instructor, prompting Text messages, and financial Incentives to attend yoga classes Receives: Behavioral: Weekly Yoga Classes

What is being measured

The primary outcome is the main question the study is designed to answer.

Yoga Dosage
Total minutes per week practicing yoga, including in class and outside of class, assessed weekly via interview
Measured: 3 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

20 Feb 202231 Aug 2025

First posted23 Nov 2020
Study start20 Feb 2022
Primary completion15 Nov 2024
Study completion31 Aug 2025

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Publications (1)Papers the sponsor has linked to this study.
Other trials for Opioid UseStudies of the same condition, open and under way.
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: Other
Allocation: Randomised
Intervention model: Factorial
Masking: Double blind
Who is masked: Investigator, Outcomes assessor
Enrolment: 192 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT04641221
Sponsor's protocol ID: 202002-002-2
Other IDs: R01AT010863
Acronym: YOGAMAT-II
Status last verified: Oct 2025
First submitted: 16 Nov 2020
Last updated: 20 Nov 2025
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: Yes
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: No

Publications

Uebelacker LA, Braun TD, Taylor LE, Saper R, Baldwi M, Abrantes A, Tremont G, Toribio A, Kirshy S, Koch R, Lorin L, Van Noppen D, Anderson B, Roseen EJ, Stein MD. Evaluation of intervention components to maximize yoga practice among people with chronic pain taking opioid agonist therapy: A factorial experiment using the multiphase optimization strategy framework. Contemp Clin Trials. 2024 Feb;137:107411. doi: 10.1016/j.cct.2023.107411. Epub 2023 Dec 14.
PubMed 38103784

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

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Study at a glance

From the registry record, last updated by the sponsor on 20 Nov 2025. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Optimization and Multi-Site Feasibility of Yoga for Chronic Pain in People in YOGAMAT-II - Phase II
ClinicalTrials.gov ID: NCT04641221
Acronym / sponsor ID: YOGAMAT-II / 202002-002-2
Conditions: Opioid Use, Chronic Pain
Study type: Interventional
Recruitment status: Completed
Enrolment: 192 participants (actual)
Lead sponsor: Butler HospitalUniversity, hospital or other
Collaborators: National Center for Complementary and Integrative Health (NCCIH)
Study start: 20 Feb 2022 (actual)
Primary completion: 15 Nov 2024 (actual)
Study completion: 31 Aug 2025 (actual)
First posted: 23 Nov 2020 (actual)
Results: Posted 20 Nov 2025

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Phase 2 - Multiphase Optimization Strategy (MOST) Optimization Phase:

To conduct a factorial experiment that will allow us to evaluate the impact of each of the 4 intervention components on yoga dosage received. We will enroll a total n=192. All participants will receive the core yoga intervention, with random assignment to the four intervention components outlined above.
Use results from Phase 2 to choose an efficient combination of intervention components that, together with standard yoga classes, maximizes yoga dosage.
Examine mechanisms by which components are hypothesized to work.

Detailed description

Study design

Primary purpose: Other
Allocation: Randomised
Intervention model: Factorial
Masking: Double blind (investigator, outcomes assessor)
Number of arms: 16

Arm	Type	Receives
No Video/No One-on-One/No Text/No Incentive	Active comparator	Behavioral: Weekly Yoga ClassesThis group does not receive Personal Practice Videos, or One-on-One individual sessions with a Yoga Instructor, or prompting Text messages, or financial Incentives to attend yoga classes
No Video/No One-on-One/No Text/Yes Incentive	Active comparator	Behavioral: Weekly Yoga ClassesThis group does not receive Personal Practice Videos, or One-on-One individual sessions with a Yoga Instructor, or prompting Text messages, but DOES receive financial Incentives to attend yoga classes
No Video/No One-on-One/Yes Text/No Incentive	Active comparator	Behavioral: Weekly Yoga ClassesThis group does not receive Personal Practice Videos, or One-on-One individual sessions with a Yoga Instructor, or financial Incentives to attend yoga classes, but DOES receive prompting Text messages
No Video/No One-on-One/Yes Text/Yes Incentive	Active comparator	Behavioral: Weekly Yoga ClassesThis group does not receive Personal Practice Videos, or One-on-One individual sessions with a Yoga Instructor, but DOES receive prompting Text messages and financial Incentives to attend yoga classes
No Video/Yes One-on-One/No Text/No Incentive	Active comparator	Behavioral: Weekly Yoga ClassesThis group does not receive Personal Practice Videos or prompting Text messages or financial Incentives to attend yoga classes, but DOES receive One-on-One individual sessions with a Yoga Instructor
No Video/Yes One-on-One/No Text/Yes Incentive	Active comparator	Behavioral: Weekly Yoga ClassesThis group does not receive Personal Practice Videos or prompting Text messages, but DOES receive One-on-One individual sessions with a Yoga Instructor, and financial Incentives to attend yoga classes
No Video/Yes One-on-One/Yes Text/No Incentive	Active comparator	Behavioral: Weekly Yoga ClassesThis group does not receive Personal Practice Videos or financial Incentives to attend yoga classes, but DOES receive One-on-One individual sessions with a Yoga Instructor and prompting Text messages
No Video/Yes One-on-One/Yes Text/Yes Incentive	Active comparator	Behavioral: Weekly Yoga ClassesThis group does not receive Personal Practice Videos, but DOES receive One-on-One individual sessions with a Yoga Instructor, prompting Text messages, and financial Incentives to attend yoga classes
Yes Video/No One-on-One/No Text/No Incentive	Active comparator	Behavioral: Weekly Yoga ClassesThis group does not receive One-on-One individual sessions with a Yoga Instructor, or prompting Text messages, or financial Incentives to attend yoga classes, but DOES receive Personal Practice Videos
Yes Video/No One-on-One/No Text/Yes Incentive	Active comparator	Behavioral: Weekly Yoga ClassesThis group does not receive One-on-One individual sessions with a Yoga Instructor or prompting Text messages, but DOES receive Personal Practice Videos and financial Incentives to attend yoga classes
Yes Video/No One-on-One/Yes Text/No Incentive	Active comparator	Behavioral: Weekly Yoga ClassesThis group does not receive One-on-One individual sessions with a Yoga Instructor or financial Incentives to attend yoga classes, but DOES receive Personal Practice Videos and prompting Text messages
Yes Video/No One-on-One/Yes Text/Yes Incentive	Active comparator	Behavioral: Weekly Yoga ClassesThis group does not receive One-on-One individual sessions with a Yoga Instructor, but DOES receive Personal Practice Videos, prompting Text messages, and financial Incentives to attend yoga classes
Yes Video/Yes One-on-One/No Text/No Incentive	Active comparator	Behavioral: Weekly Yoga ClassesThis group does not receive prompting Text messages or financial Incentives to attend yoga classes, but DOES receive Personal Practice Videos and One-on-One individual sessions with a Yoga Instructor
Yes Video/Yes One-on-One/No Text/Yes Incentive	Active comparator	Behavioral: Weekly Yoga ClassesThis group does not receive prompting Text messages, but DOES receive Personal Practice Videos, One-on-One individual sessions with a Yoga Instructor, and financial Incentives to attend yoga classes
Yes Video/Yes One-on-One/Yes Text/No Incentive	Active comparator	Behavioral: Weekly Yoga ClassesThis group does not receive financial Incentives to attend yoga classes, but DOES receive Personal Practice Videos, One-on-One individual sessions with a Yoga Instructor and prompting Text messages
Yes Video/Yes One-on-One/Yes Text/Yes Incentive	Active comparator	Behavioral: Weekly Yoga ClassesThis group receives Personal Practice Videos, One-on-One individual sessions with a Yoga Instructor, prompting Text messages, and financial Incentives to attend yoga classes

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (6 listed)

Enrolled in MMT or BUP treatment for > 3 months
Plan to continue treatment for next 6 months
Chronic pain, defined as pain for at least half the days over the previous three months, a mean score of 4 or higher on the Brief Pain Interference Scale (BPI; with reference to chronic pain), and pain severity of 4 or higher on a Visual Analog Scale (0-10) indicating "worst pain in the last week." Pain severity score will also refer to the areas of their body in which they have chronic pain.
Aged > 18
Proficiency in English sufficient to engage in informed consent in English, understand classes taught in English, and read short sentences

Key exclusion criteria (7 listed)

Currently taking yoga classes or practicing yoga at home once per week or more often.
Medical conditions that would make participation in yoga unsafe or not possible, including active malignancy treatment, fracture, recent joint surgery, use of assistive ambulatory devices other than a cane. . (In cases where this is unclear, site PI will make final determination based on available evidence.)
Severe or progressive neurologic deficits. (In cases where this is unclear, site PI will make final determination based on available evidence.)
Other severe disabling chronic medical and/or psychiatric comorbidities deemed by the site PI on a case-by-case basis to prevent safe or adequate participation in the study (e.g., cognitive impairment that prevents a participant from understanding assessments; history of disruptive behavior in medical settings; severe disabling heart failure or lung disease)
Surgery requiring overnight hospitalization planned in the next 3 months

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
Weekly Yoga ClassesAll participants are invited to attend weekly yoga classes.	Behavioural	No Video/No One-on-One/No Text/No Incentive, No Video/No One-on-One/No Text/Yes Incentive, No Video/No One-on-One/Yes Text/No Incentive, No Video/No One-on-One/Yes Text/Yes Incentive, No Video/Yes One-on-One/No Text/No Incentive, No Video/Yes One-on-One/No Text/Yes Incentive, No Video/Yes One-on-One/Yes Text/No Incentive, No Video/Yes One-on-One/Yes Text/Yes Incentive, Yes Video/No One-on-One/No Text/No Incentive, Yes Video/No One-on-One/No Text/Yes Incentive, Yes Video/No One-on-One/Yes Text/No Incentive, Yes Video/No One-on-One/Yes Text/Yes Incentive, Yes Video/Yes One-on-One/No Text/No Incentive, Yes Video/Yes One-on-One/No Text/Yes Incentive, Yes Video/Yes One-on-One/Yes Text/No Incentive, Yes Video/Yes One-on-One/Yes Text/Yes Incentive

Primary outcome

Yoga Dosage
Time frame: 3 months
Total minutes per week practicing yoga, including in class and outside of class, assessed weekly via interview

Results and safety

Results posted to the registry on 20 Nov 2025, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
No Video/No One-on-One/No Text/No Incentive	12	10
No Video/No One-on-One/No Text/Yes Incentive	12	11
No Video/No One-on-One/Yes Text/No Incentive	12	9
No Video/No One-on-One/Yes Text/Yes Incentive	12	9
No Video/Yes One-on-One/No Text/No Incentive	12	9
No Video/Yes One-on-One/No Text/Yes Incentive	12	12
No Video/Yes One-on-One/Yes Text/No Incentive	12	7
No Video/Yes One-on-One/Yes Text/Yes Incentive	12	11
Yes Video/No One-on-One/No Text/No Incentive	12	6
Yes Video/No One-on-One/No Text/Yes Incentive	12	9
Yes Video/No One-on-One/Yes Text/No Incentive	12	10
Yes Video/No One-on-One/Yes Text/Yes Incentive	12	6
Yes Video/Yes One-on-One/No Text/No Incentive	12	8
Yes Video/Yes One-on-One/No Text/Yes Incentive	12	8
Yes Video/Yes One-on-One/Yes Text/No Incentive	12	5
Yes Video/Yes One-on-One/Yes Text/Yes Incentive	12	8

Primary outcome: Yoga Dosage

Time frame: 3 months. Mean (90% Confidence Interval). Unit: Total yoga Minutes

Measure	No Video/No One-on-One/No Text/No Incentive n = 12	No Video/No One-on-One/No Text/Yes Incentive n = 12	No Video/No One-on-One/Yes Text/No Incentive n = 12	No Video/No One-on-One/Yes Text/Yes Incentive n = 12	No Video/Yes One-on-One/No Text/No Incentive n = 12	No Video/Yes One-on-One/No Text/Yes Incentive n = 12	No Video/Yes One-on-One/Yes Text/No Incentive n = 12	No Video/Yes One-on-One/Yes Text/Yes Incentive n = 12	Yes Video/No One-on-One/No Text/No Incentive n = 12	Yes Video/No One-on-One/No Text/Yes Incentive n = 12	Yes Video/No One-on-One/Yes Text/No Incentive n = 12	Yes Video/No One-on-One/Yes Text/Yes Incentive n = 12	Yes Video/Yes One-on-One/No Text/No Incentive n = 12	Yes Video/Yes One-on-One/No Text/Yes Incentive n = 12	Yes Video/Yes One-on-One/Yes Text/No Incentive n = 12	Yes Video/Yes One-on-One/Yes Text/Yes Incentive n = 12
Value	164.5 (100.2 to 228.8)	99.4 (67.4 to 131.5)	139.1 (108.8 to 169.4)	102.2 (72.2 to 132.1)	116.6 (73.9 to 159.3)	154.8 (113.8 to 195.8)	84.5 (68.5 to 100.6)	185.6 (118.9 to 252.4)	89.7 (72.6 to 106.8)	90.9 (68.5 to 113.4)	111.4 (67.0 to 155.7)	122.3 (98.1 to 146.4)	145.8 (99.6 to 192.0)	144.9 (116.6 to 173.1)	167.0 (129.1 to 204.8)	117.2 (83.0 to 151.4)

No Video/No One-on-One/No Text/No Incentive vs No Video/No One-on-One/No Text/Yes Incentive vs No Video/No One-on-One/Yes Text/No Incentive vs No Video/No One-on-One/Yes Text/Yes Incentive vs No Video/Yes One-on-One/No Text/No Incentive vs No Video/Yes One-on-One/No Text/Yes Incentive vs No Video/Yes One-on-One/Yes Text/No Incentive vs No Video/Yes One-on-One/Yes Text/Yes Incentive vs Yes Video/No One-on-One/No Text/No Incentive vs Yes Video/No One-on-One/No Text/Yes Incentive vs Yes Video/No One-on-One/Yes Text/No Incentive vs Yes Video/No One-on-One/Yes Text/Yes Incentive vs Yes Video/Yes One-on-One/No Text/No Incentive vs Yes Video/Yes One-on-One/No Text/Yes Incentive vs Yes Video/Yes One-on-One/Yes Text/No Incentive vs Yes Video/Yes One-on-One/Yes Text/Yes Incentive: incidence rate ratio: 1.10 (90% CI 1.02 to 1.18), p = 0.028, zero-inflated negative-binomial (ZINB)
No Video/No One-on-One/No Text/No Incentive vs No Video/No One-on-One/No Text/Yes Incentive vs No Video/No One-on-One/Yes Text/No Incentive vs No Video/No One-on-One/Yes Text/Yes Incentive vs No Video/Yes One-on-One/No Text/No Incentive vs No Video/Yes One-on-One/No Text/Yes Incentive vs No Video/Yes One-on-One/Yes Text/No Incentive vs No Video/Yes One-on-One/Yes Text/Yes Incentive vs Yes Video/No One-on-One/No Text/No Incentive vs Yes Video/No One-on-One/No Text/Yes Incentive vs Yes Video/No One-on-One/Yes Text/No Incentive vs Yes Video/No One-on-One/Yes Text/Yes Incentive vs Yes Video/Yes One-on-One/No Text/No Incentive vs Yes Video/Yes One-on-One/No Text/Yes Incentive vs Yes Video/Yes One-on-One/Yes Text/No Incentive vs Yes Video/Yes One-on-One/Yes Text/Yes Incentive: incidence rate ratio: 1.09 (90% CI 1.02 to 1.17), p = 0.039, zero-inflated negative binomial
No Video/No One-on-One/No Text/No Incentive vs No Video/No One-on-One/No Text/Yes Incentive vs No Video/No One-on-One/Yes Text/No Incentive vs No Video/No One-on-One/Yes Text/Yes Incentive vs No Video/Yes One-on-One/No Text/No Incentive vs No Video/Yes One-on-One/No Text/Yes Incentive vs No Video/Yes One-on-One/Yes Text/No Incentive vs No Video/Yes One-on-One/Yes Text/Yes Incentive vs Yes Video/No One-on-One/No Text/No Incentive vs Yes Video/No One-on-One/No Text/Yes Incentive vs Yes Video/No One-on-One/Yes Text/No Incentive vs Yes Video/No One-on-One/Yes Text/Yes Incentive vs Yes Video/Yes One-on-One/No Text/No Incentive vs Yes Video/Yes One-on-One/No Text/Yes Incentive vs Yes Video/Yes One-on-One/Yes Text/No Incentive vs Yes Video/Yes One-on-One/Yes Text/Yes Incentive: incident rate ratio: 0.86 (90% CI 0.80 to 0.93), p = 0.001, Zero-inflated negative binomial

Adverse events

Time frame: 12 months. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
No Video/No One-on-One/No Text/No Incentive	4 of 12 (33.3%)	9 of 12 (75%)	0 of 12
No Video/No One-on-One/No Text/Yes Incentive	3 of 12 (25%)	9 of 12 (75%)	0 of 12
No Video/No One-on-One/Yes Text/No Incentive	3 of 12 (25%)	6 of 12 (50%)	0 of 12
No Video/No One-on-One/Yes Text/Yes Incentive	2 of 12 (16.7%)	7 of 12 (58.3%)	0 of 12
No Video/Yes One-on-One/No Text/No Incentive	3 of 12 (25%)	5 of 12 (41.7%)	0 of 12
No Video/Yes One-on-One/No Text/Yes Incentive	1 of 12 (8.3%)	8 of 12 (66.7%)	0 of 12
No Video/Yes One-on-One/Yes Text/No Incentive	2 of 12 (16.7%)	10 of 12 (83.3%)	0 of 12
No Video/Yes One-on-One/Yes Text/Yes Incentive	1 of 12 (8.3%)	5 of 12 (41.7%)	0 of 12
Yes Video/No One-on-One/No Text/No Incentive	2 of 12 (16.7%)	8 of 12 (66.7%)	0 of 12
Yes Video/No One-on-One/No Text/Yes Incentive	1 of 12 (8.3%)	9 of 12 (75%)	0 of 12
Yes Video/No One-on-One/Yes Text/No Incentive	2 of 12 (16.7%)	7 of 12 (58.3%)	0 of 12
Yes Video/No One-on-One/Yes Text/Yes Incentive	4 of 12 (33.3%)	8 of 12 (66.7%)	0 of 12
Yes Video/Yes One-on-One/No Text/No Incentive	1 of 12 (8.3%)	8 of 12 (66.7%)	0 of 12
Yes Video/Yes One-on-One/No Text/Yes Incentive	1 of 12 (8.3%)	6 of 12 (50%)	0 of 12
Yes Video/Yes One-on-One/Yes Text/No Incentive	3 of 12 (25%)	7 of 12 (58.3%)	0 of 12
Yes Video/Yes One-on-One/Yes Text/Yes Incentive	1 of 12 (8.3%)	8 of 12 (66.7%)	0 of 12

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Research links

Official record on ClinicalTrials.govLast updated by the sponsor 20 Nov 2025.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Derived from this study: PubMed 38103784Uebelacker LA, Braun TD, Taylor LE, Saper R, Baldwi M, Abrantes A, Tremont G, Toribio A, Kirshy S, Koch R, Lorin L, Van Noppen D, Anderson B, Roseen EJ, Stein MD. Evaluation of intervention components to maximize yoga practice among people with chronic pain taking opioid agonist therapy: A factorial experiment using the multiphase optimization strategy framework. Contemp Clin Trials. 2024 Feb;137:107411. doi: 10.1016/j.cct.2023.107411. Epub 2023 Dec 14.
Individual participant dataSharing planned: No

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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.

The record lists no contact. Use the official record to reach the sponsor.

2 sites in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A study testing Weekly Yoga Classes in people with Opioid Use and Chronic Pain, run by Butler Hospital at 2 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 6 inclusion and 7 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 20 Nov 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 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?

Yes. Results are posted in the registry (first posted 20 Nov 2025). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

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?

Yoga Dosage (time frame: 3 months). 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 NCT04641221, which also lists 1 linked publication.

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 20 Nov 2025.