Opioid UseYOGAMAT-IINCT04646148

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

A study testing 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 1 - MOST Preparation Phase: 1. To conduct a pilot trial at two opioid use disorder clinic sites, enrolling n=10 at both sites, for a total n=20. 2. Establish clinical trial procedures and document feasibility at both sites prior to conducting a fully powered optimization trial. 3. 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?: Yoga classes
Type of treatment: Lifestyle or therapy programme
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 20 participants
Where: 2 sitesUnited States
Study dates: 1 Mar 2021to 1 Nov 2021
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 methadone maintenance (MMT) or buprenorphine/naloxone (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
Plan to move out of the area within 6 months.
Homeless, defined as any time in the past month sleeping in a shelter or on the street.

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

Official title: Optimization and Multi-Site Feasibility of Yoga for Chronic Pain in People in Treatment for Opioid Use Disorder - Phase I

Phase 1 - MOST Preparation Phase:

To conduct a pilot trial at two opioid use disorder clinic sites, enrolling n=10 at both sites, for a total n=20.
Establish clinical trial procedures and document feasibility at both sites prior to conducting a fully powered optimization trial.
Demonstrate our ability to a) recruit participants; b) train yoga teachers to fidelity; c) randomize participants to intervention components and correctly administer components; d) run classes; and e) collect follow-up assessments.

Read the detailed description

In Phase 1, we will enroll 10 participants at each recruitment site (n=20). The purpose of Phase 1 (MOST Preparation Phase) is to allow us to establish and refine procedures at these new sites and document aspects of feasibility, including our ability to a) recruit participants; b) train yoga teachers to fidelity; c) randomize participants to intervention components and correctly administer these components; d) run classes; and e) collect follow-up assessments. Enrollment period for this phase will last approximately 4 months.

Conditions: Opioid Use, Chronic Pain
Being tested: 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.

Yoga classesBehavioural
All participants are invited to attend weekly yoga classes.

Study groups in NCT04646148
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: 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: 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 recieve prompting Text messages, Receives: Behavioral: 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: 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: 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 financial Incentives to attend yoga classes and One-on-One individual sessions with a Yoga Instructor Receives: Behavioral: 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 prompting Text messages and One-on-One individual sessions with a Yoga Instructor Receives: Behavioral: 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 financial Incentives to attend yoga classes, prompting Text messages and One-on-One individual sessions with a Yoga Instructor Receives: Behavioral: Yoga classes
Yes Video/No One-on-One/No Text/No Incentive	Active comparator	This group does not receive financial Incentives to attend yoga classes, prompting Text messages or One-on-One individual sessions with a Yoga Instructor, but DOES receive Personal Practice Videos Receives: Behavioral: Yoga classes
Yes Video/No One-on-One/No Text/Yes Incentive	Active comparator	This group does not receive prompting Text messages or One-on-One individual sessions with a Yoga Instructor, but DOES receive financial Incentives to attend yoga classes and Personal Practice Videos Receives: Behavioral: Yoga classes
Yes Video/No One-on-One/Yes Text/No Incentive	Active comparator	This group does not receive financial Incentives to attend yoga classes, or One-on-One individual sessions with a Yoga Instructor, but DOES receive Personal Practice Videos and prompting Text messages Receives: Behavioral: 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: 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 One-on-One individual sessions with a Yoga Instructor and Personal Practice Videos Receives: Behavioral: 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 financial Incentives to attend yoga classes, One-on-One individual sessions with a Yoga Instructor and Personal Practice Videos Receives: Behavioral: 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 prompting Text messages, One-on-One individual sessions with a Yoga Instructor and Personal Practice Videos Receives: Behavioral: 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: Yoga classes

What is being measured

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

Number of Participants Recruited
As this is a pilot study, a key outcome is number of participants recruited
Measured: 4 months
Number of Yoga Teachers Trained to > 80% Fidelity to the Manual
As this is a pilot study, an outcome is to assess whether we can train teachers to an acceptable level of fidelity
Measured: 7 months
Percent of Weeks Where Data on Amount of Yoga Personal Practice Were Collected
As this is a pilot study, an outcome is percentage of weeks where data on amount of yoga personal practice were collected. The total number of weeks possible = 12. These data are most important as they will be used to derive the primary outcome in the next phase of this research (total amount of yoga practice.)
Measured: 3 months

Timeline

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

1 Mar 20211 Nov 2021

First posted27 Nov 2020
Study start1 Mar 2021
Primary completion1 Nov 2021
Study completion1 Nov 2021

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.
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: 20 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT04646148
Sponsor's protocol ID: 202002-002-1
Other IDs: U01AT010863
Acronym: YOGAMAT-II
Status last verified: Aug 2022
First submitted: 12 Nov 2020
Last updated: 14 Sep 2022
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: Yes
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: No

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?

See locations

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People Who Use Opioids/People With Opioid Use Disorder (OUD)
Enrolling by invitationObservational study
Development of an Interview-Informed Timeline Follow-Back (TLFB) for Opioid Use in the Era of Fentanyl
Substance Use Disorders (SUDs)
Not yet recruiting
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Sleep-Disordered Breathing, Chronic Opioid Use
Active, not recruitingPhase 2
Wellcome Leap Psilocybin for OUD
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Recruiting
Opioid and Pain Treatment in Indigenous Communities (OPTIC) Trial
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All Opioid Use trials

Study at a glance

From the registry record, last updated by the sponsor on 14 Sep 2022. 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 Treatment for Opioid Use Disorder - Phase I
ClinicalTrials.gov ID: NCT04646148
Acronym / sponsor ID: YOGAMAT-II / 202002-002-1
Conditions: Opioid Use, Chronic Pain
Study type: Interventional
Recruitment status: Completed
Enrolment: 20 participants (actual)
Lead sponsor: Butler HospitalUniversity, hospital or other
Collaborators: National Center for Complementary and Integrative Health (NCCIH)
Study start: 1 Mar 2021 (actual)
Primary completion: 1 Nov 2021 (actual)
Study completion: 1 Nov 2021 (actual)
First posted: 27 Nov 2020 (actual)
Results: Posted 14 Sep 2022

Clinical summary

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

Phase 1 - MOST Preparation Phase:

To conduct a pilot trial at two opioid use disorder clinic sites, enrolling n=10 at both sites, for a total n=20.
Establish clinical trial procedures and document feasibility at both sites prior to conducting a fully powered optimization trial.
Demonstrate our ability to a) recruit participants; b) train yoga teachers to fidelity; c) randomize participants to intervention components and correctly administer components; d) run classes; and e) collect follow-up assessments.

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: 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: 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: 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 recieve prompting Text messages,
No Video/No One-on-One/Yes Text/Yes Incentive	Active comparator	Behavioral: 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: 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: Yoga classesThis group does not receive Personal Practice Videos, or prompting Text messages, but DOES receive financial Incentives to attend yoga classes and One-on-One individual sessions with a Yoga Instructor
No Video/Yes One-on-One/Yes Text/No Incentive	Active comparator	Behavioral: Yoga classesThis group does not receive Personal Practice Videos, or financial Incentives to attend yoga classes, but DOES receive prompting Text messages and One-on-One individual sessions with a Yoga Instructor
No Video/Yes One-on-One/Yes Text/Yes Incentive	Active comparator	Behavioral: Yoga classesThis group does not receive Personal Practice Videos, but DOES receive financial Incentives to attend yoga classes, prompting Text messages and One-on-One individual sessions with a Yoga Instructor
Yes Video/No One-on-One/No Text/No Incentive	Active comparator	Behavioral: Yoga classesThis group does not receive financial Incentives to attend yoga classes, prompting Text messages or One-on-One individual sessions with a Yoga Instructor, but DOES receive Personal Practice Videos
Yes Video/No One-on-One/No Text/Yes Incentive	Active comparator	Behavioral: Yoga classesThis group does not receive prompting Text messages or One-on-One individual sessions with a Yoga Instructor, but DOES receive financial Incentives to attend yoga classes and Personal Practice Videos
Yes Video/No One-on-One/Yes Text/No Incentive	Active comparator	Behavioral: Yoga classesThis group does not receive financial Incentives to attend yoga classes, or One-on-One individual sessions with a Yoga Instructor, but DOES receive Personal Practice Videos and prompting Text messages
Yes Video/No One-on-One/Yes Text/Yes Incentive	Active comparator	Behavioral: 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: Yoga classesThis group does not receive prompting Text messages or financial Incentives to attend yoga classes, but DOES receive One-on-One individual sessions with a Yoga Instructor and Personal Practice Videos
Yes Video/Yes One-on-One/No Text/Yes Incentive	Active comparator	Behavioral: Yoga classesThis group does not receive prompting Text messages but DOES receive financial Incentives to attend yoga classes, One-on-One individual sessions with a Yoga Instructor and Personal Practice Videos
Yes Video/Yes One-on-One/Yes Text/No Incentive	Active comparator	Behavioral: Yoga classesThis group does not receive financial Incentives to attend yoga classes, but DOES receive prompting Text messages, One-on-One individual sessions with a Yoga Instructor and Personal Practice Videos
Yes Video/Yes One-on-One/Yes Text/Yes Incentive	Active comparator	Behavioral: 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 methadone maintenance (MMT) or buprenorphine/naloxone (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 (8 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
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

Number of Participants Recruited
Time frame: 4 months
As this is a pilot study, a key outcome is number of participants recruited
Number of Yoga Teachers Trained to > 80% Fidelity to the Manual
Time frame: 7 months
As this is a pilot study, an outcome is to assess whether we can train teachers to an acceptable level of fidelity
Percent of Weeks Where Data on Amount of Yoga Personal Practice Were Collected
Time frame: 3 months
As this is a pilot study, an outcome is percentage of weeks where data on amount of yoga personal practice were collected. The total number of weeks possible = 12. These data are most important as they will be used to derive the primary outcome in the next phase of this research (total amount of yoga practice.)

Results and safety

Results posted to the registry on 14 Sep 2022, 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	0	0
No Video/No One-on-One/No Text/Yes Incentive	1	0
No Video/No One-on-One/Yes Text/No Incentive	0	0
No Video/No One-on-One/Yes Text/Yes Incentive	1	1
No Video/Yes One-on-One/No Text/No Incentive	1	0
No Video/Yes One-on-One/No Text/Yes Incentive	2	1
No Video/Yes One-on-One/Yes Text/No Incentive	1	0
No Video/Yes One-on-One/Yes Text/Yes Incentive	2	1
Yes Video/No One-on-One/No Text/No Incentive	1	1
Yes Video/No One-on-One/No Text/Yes Incentive	2	2
Yes Video/No One-on-One/Yes Text/No Incentive	1	1
Yes Video/No One-on-One/Yes Text/Yes Incentive	2	2
Yes Video/Yes One-on-One/No Text/No Incentive	1	1
Yes Video/Yes One-on-One/No Text/Yes Incentive	1	1
Yes Video/Yes One-on-One/Yes Text/No Incentive	2	2
Yes Video/Yes One-on-One/Yes Text/Yes Incentive	2	0

Primary outcome: Number of Participants Recruited

Time frame: 4 months. Count of participants. Unit: Participants

Measure	Entire Study n = 20
Value	20

Primary outcome: Number of Yoga Teachers Trained to > 80% Fidelity to the Manual

Time frame: 7 months. Count of participants. Unit: Participants

Measure	Entire Study n = 5
Value	4

Population analysed: 5 yoga teachers trained and taught classes

Primary outcome: Percent of Weeks Where Data on Amount of Yoga Personal Practice Were Collected

Time frame: 3 months. Mean (Standard Deviation). Unit: percentage of weeks

Measure	No Video/No One-on-One/No Text/No Incentive n = 0	No Video/No One-on-One/No Text/Yes Incentive n = 1	No Video/No One-on-One/Yes Text/No Incentive n = 0	No Video/No One-on-One/Yes Text/Yes Incentive n = 1	No Video/Yes One-on-One/No Text/No Incentive n = 1	No Video/Yes One-on-One/No Text/Yes Incentive n = 2	No Video/Yes One-on-One/Yes Text/No Incentive n = 1	No Video/Yes One-on-One/Yes Text/Yes Incentive n = 2	Yes Video/No One-on-One/No Text/No Incentive n = 1	Yes Video/No One-on-One/No Text/Yes Incentive n = 2	Yes Video/No One-on-One/Yes Text/No Incentive n = 1	Yes Video/No One-on-One/Yes Text/Yes Incentive n = 2	Yes Video/Yes One-on-One/No Text/No Incentive n = 1	Yes Video/Yes One-on-One/No Text/Yes Incentive n = 1	Yes Video/Yes One-on-One/Yes Text/No Incentive n = 2	Yes Video/Yes One-on-One/Yes Text/Yes Incentive n = 2
Value	–	100 (0)	–	100 (0)	8.3 (0)	62.5 (53.03)	100 (0)	58.3 (58.92)	100 (0)	100 (0)	100 (0)	100 (0)	100 (0)	100 (0)	100 (0)	12.5 (17.68)

Population analysed: By design, no one was assigned to group 1 or 3.

Adverse events

Time frame: 3 months -- this is the length of time that any one participant was enrolled in the study.. Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
No Video/No One-on-One/No Text/No Incentive	0 of 0	0 of 0	0
No Video/No One-on-One/No Text/Yes Incentive	0 of 1 (0%)	0 of 1 (0%)	0 of 1
No Video/No One-on-One/Yes Text/No Incentive	0 of 0	0 of 0	0
No Video/No One-on-One/Yes Text/Yes Incentive	0 of 1 (0%)	1 of 1 (100%)	0 of 1
No Video/Yes One-on-One/No Text/No Incentive	0 of 1 (0%)	0 of 1 (0%)	0 of 1
No Video/Yes One-on-One/No Text/Yes Incentive	0 of 2 (0%)	0 of 2 (0%)	0 of 2
No Video/Yes One-on-One/Yes Text/No Incentive	0 of 1 (0%)	0 of 1 (0%)	0 of 1
No Video/Yes One-on-One/Yes Text/Yes Incentive	0 of 2 (0%)	1 of 2 (50%)	0 of 2
Yes Video/No One-on-One/No Text/No Incentive	0 of 1 (0%)	0 of 1 (0%)	0 of 1
Yes Video/No One-on-One/No Text/Yes Incentive	0 of 2 (0%)	1 of 2 (50%)	0 of 2
Yes Video/No One-on-One/Yes Text/No Incentive	0 of 1 (0%)	0 of 1 (0%)	0 of 1
Yes Video/No One-on-One/Yes Text/Yes Incentive	0 of 2 (0%)	1 of 2 (50%)	0 of 2
Yes Video/Yes One-on-One/No Text/No Incentive	0 of 1 (0%)	1 of 1 (100%)	0 of 1
Yes Video/Yes One-on-One/No Text/Yes Incentive	0 of 1 (0%)	1 of 1 (100%)	0 of 1
Yes Video/Yes One-on-One/Yes Text/No Incentive	0 of 2 (0%)	2 of 2 (100%)	0 of 2
Yes Video/Yes One-on-One/Yes Text/Yes Incentive	0 of 2 (0%)	1 of 2 (50%)	0 of 2

Limitations and caveats (from the sponsor): This was a pilot study that was designed to assess feasibility of the proposed design prior to starting a larger trial.

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 14 Sep 2022.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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 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 8 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 14 Sep 2022. 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 14 Sep 2022). 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?

Number of Participants Recruited (time frame: 4 months). The study lists 3 primary outcomes in all. 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 NCT04646148.

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 14 Sep 2022.