Last reviewed 2025-11-20 · How we verify
Home › Trials › NCT04641221 NCT04641221: YOGAMAT-II
Optimization and Multi-Site Feasibility of Yoga for Chronic Pain in People in YOGAMAT-II - Phase II
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Summary Quick facts Who can join Endpoints Results Adverse events Publications Related trials Sources
Completed
NA
Results posted
Last updated 20 November 2025
What this trial tests
NA trial testing Weekly Yoga Classes in Opioid Use in 192 participants. Completed in 31 August 2025.
Timeline
20 February 2022
Primary endpoint
31 August 2025
Quick facts
Lead sponsor Butler Hospital Phase NA Status Completed Study type INTERVENTIONAL Allocation randomized Design factorial Masking double Primary purpose other Enrollment 192 Start date 20 February 2022 Primary completion 15 November 2024 Estimated completion 31 August 2025 Sites 2 locations across United States
Drugs / interventions tested
Conditions studied
Sponsor
Butler Hospital
Who can join
18 and older, any sex, with Opioid Use or Chronic Pain. Patients with the condition only — healthy volunteers not accepted.
Results — posted to ClinicalTrials.gov
Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.
Yoga Dosage
Primary
· 3 months
Total minutes per week practicing yoga, including in class and outside of class, assessed weekly via interview
Group Value 95% CI No Video/No One-on-One/No Text/No Incentive 164.5 100.2 – 228.8 No Video/No One-on-One/No Text/Yes Incentive 99.4 67.4 – 131.5 No Video/No One-on-One/Yes Text/No Incentive 139.1 108.8 – 169.4 No Video/No One-on-One/Yes Text/Yes Incentive 102.2 72.2 – 132.1 No Video/Yes One-on-One/No Text/No Incentive 116.6 73.9 – 159.3 No Video/Yes One-on-One/No Text/Yes Incentive 154.8 113.8 – 195.8 No Video/Yes One-on-One/Yes Text/No Incentive 84.5 68.5 – 100.6 No Video/Yes One-on-One/Yes Text/Yes Incentive 185.6 118.9 – 252.4 Yes Video/No One-on-One/No Text/No Incentive 89.7 72.6 – 106.8 Yes Video/No One-on-One/No Text/Yes Incentive 90.9 68.5 – 113.4 Yes Video/No One-on-One/Yes Text/No Incentive 111.4 67.0 – 155.7 Yes Video/No One-on-One/Yes Text/Yes Incentive 122.3 98.1 – 146.4
Adverse events — posted to ClinicalTrials.gov
Time frame: 12 months.
Reporting threshold: 0%.
Adverse-event reports describe events observed during the trial — not all are caused by the drug.
No Video/No One-on-One/No Text/No Incentive
Serious: 4/12 (33%)
Deaths: 0/12
No Video/No One-on-One/No Text/Yes Incentive
Serious: 3/12 (25%)
Deaths: 0/12
No Video/No One-on-One/Yes Text/No Incentive
Serious: 3/12 (25%)
Deaths: 0/12
No Video/No One-on-One/Yes Text/Yes Incentive
Serious: 2/12 (17%)
Deaths: 0/12
No Video/Yes One-on-One/No Text/No Incentive
Serious: 3/12 (25%)
Deaths: 0/12
No Video/Yes One-on-One/No Text/Yes Incentive
Serious: 1/12 (8%)
Deaths: 0/12
No Video/Yes One-on-One/Yes Text/No Incentive
Serious: 2/12 (17%)
Deaths: 0/12
No Video/Yes One-on-One/Yes Text/Yes Incentive
Serious: 1/12 (8%)
Deaths: 0/12
Yes Video/No One-on-One/No Text/No Incentive
Serious: 2/12 (17%)
Deaths: 0/12
Yes Video/No One-on-One/No Text/Yes Incentive
Serious: 1/12 (8%)
Deaths: 0/12
Yes Video/No One-on-One/Yes Text/No Incentive
Serious: 2/12 (17%)
Deaths: 0/12
Yes Video/No One-on-One/Yes Text/Yes Incentive
Serious: 4/12 (33%)
Deaths: 0/12
Yes Video/Yes One-on-One/No Text/No Incentive
Serious: 1/12 (8%)
Deaths: 0/12
Yes Video/Yes One-on-One/No Text/Yes Incentive
Serious: 1/12 (8%)
Deaths: 0/12
Yes Video/Yes One-on-One/Yes Text/No Incentive
Serious: 3/12 (25%)
Deaths: 0/12
Yes Video/Yes One-on-One/Yes Text/Yes Incentive
Serious: 1/12 (8%)
Deaths: 0/12
Serious adverse events (31 terms) Reaction System No Video/No One-on-One/No … No Video/No One-on-One/No … No Video/No One-on-One/Yes… No Video/No One-on-One/Yes… No Video/Yes One-on-One/No… No Video/Yes One-on-One/No… No Video/Yes One-on-One/Ye… No Video/Yes One-on-One/Ye… Yes Video/No One-on-One/No… Yes Video/No One-on-One/No… Yes Video/No One-on-One/Ye… Yes Video/No One-on-One/Ye… Yes Video/Yes One-on-One/N… Yes Video/Yes One-on-One/N… Yes Video/Yes One-on-One/Y… Yes Video/Yes One-on-One/Y… Surgical and medical procedures - Other, specify Surgical and medical procedures — — — — — — — — — — — — — — — — Anemia Blood and lymphatic system disorders — — — — — — — — — — — — — — — — Anxiety Psychiatric disorders — — — — — — — — — — — — — — — — Arthralgia Musculoskeletal and connective tissue disorders — — — — — — — — — — — — — — — — Back pain Musculoskeletal and connective tissue disorders — — — — — — — — — — — — — — — — Fall Injury, poisoning and procedural complications — — — — — — — — — — — — — — — — Flu-like symptoms General disorders — — — — — — — — — — — — — — — — Fracture Injury, poisoning and procedural complications — — — — — — — — — — — — — — — — Gastric ulcer Gastrointestinal disorders — — — — — — — — — — — — — — — — General disorders - Other, specify General disorders — — — — — — — — — — — — — — — — Heart failure Cardiac disorders — — — — — — — — — — — — — — — — Heart failure Cardiac disorders — — — — — — — — — — — — — — — — Hyperglycemia Metabolism and nutrition disorders — — — — — — — — — — — — — — — — Infections and infestations - Other, specify Infections and infestations — — — — — — — — — — — — — — — — Injection site reaction General disorders — — — — — — — — — — — — — — — — Injury, poisoning and procedural complications - Other, specify Injury, poisoning and procedural complications — — — — — — — — — — — — — — — — Lung infection Infections and infestations — — — — — — — — — — — — — — — — Lung infection Infections and infestations — — — — — — — — — — — — — — — — Myocardial Infarction Cardiac disorders — — — — — — — — — — — — — — — — Nasal congestion Respiratory, thoracic and mediastinal disorders — — — — — — — — — — — — — — — — Psychiatric Disorders- Other, Specify Psychiatric disorders — — — — — — — — — — — — — — — — Renal calculi Renal and urinary disorders — — — — — — — — — — — — — — — — Renal calculi Renal and urinary disorders — — — — — — — — — — — — — — — — Seizure Nervous system disorders — — — — — — — — — — — — — — — — Skin infection Infections and infestations — — — — — — — — — — — — — — — —
Other adverse events (65 terms — click to expand) Reaction System No Video/No One-on-One/No … No Video/No One-on-One/No … No Video/No One-on-One/Yes… No Video/No One-on-One/Yes… No Video/Yes One-on-One/No… No Video/Yes One-on-One/No… No Video/Yes One-on-One/Ye… No Video/Yes One-on-One/Ye… Yes Video/No One-on-One/No… Yes Video/No One-on-One/No… Yes Video/No One-on-One/Ye… Yes Video/No One-on-One/Ye… Yes Video/Yes One-on-One/N… Yes Video/Yes One-on-One/N… Yes Video/Yes One-on-One/Y… Yes Video/Yes One-on-One/Y… Back pain Musculoskeletal and connective tissue disorders — — — — — — — — — — — — — — — — Arthralgia Musculoskeletal and connective tissue disorders — — — — — — — — — — — — — — — — Fall Injury, poisoning and procedural complications — — — — — — — — — — — — — — — — Arthralgia Musculoskeletal and connective tissue disorders — — — — — — — — — — — — — — — — Flu-like symptoms General disorders — — — — — — — — — — — — — — — — Fracture Injury, poisoning and procedural complications — — — — — — — — — — — — — — — — Headache Nervous system disorders — — — — — — — — — — — — — — — — Neck pain Musculoskeletal and connective tissue disorders — — — — — — — — — — — — — — — — Pain in extremity Musculoskeletal and connective tissue disorders — — — — — — — — — — — — — — — — Surgical and medical procedures - Other, specify Surgical and medical procedures — — — — — — — — — — — — — — — — Upper respiratory infection Infections and infestations — — — — — — — — — — — — — — — — Upper respiratory infection Infections and infestations — — — — — — — — — — — — — — — — Abdominal distension Gastrointestinal disorders — — — — — — — — — — — — — — — — Abdominal pain Gastrointestinal disorders — — — — — — — — — — — — — — — — Anxiety Psychiatric disorders — — — — — — — — — — — — — — — — Back pain Musculoskeletal and connective tissue disorders — — — — — — — — — — — — — — — — Bone pain Musculoskeletal and connective tissue disorders — — — — — — — — — — — — — — — — Cough Respiratory, thoracic and mediastinal disorders — — — — — — — — — — — — — — — — Depression Psychiatric disorders — — — — — — — — — — — — — — — — Depression Psychiatric disorders — — — — — — — — — — — — — — — — Dizziness Nervous system disorders — — — — — — — — — — — — — — — — Dizziness Nervous system disorders — — — — — — — — — — — — — — — — Dyspnea Respiratory, thoracic and mediastinal disorders — — — — — — — — — — — — — — — — Edema limbs General disorders — — — — — — — — — — — — — — — — Endocrine disorders - Other, specify Endocrine disorders — — — — — — — — — — — — — — — — Fall Injury, poisoning and procedural complications — — — — — — — — — — — — — — — — Fatigue General disorders — — — — — — — — — — — — — — — — Fever General disorders — — — — — — — — — — — — — — — — Flu-like symptoms General disorders — — — — — — — — — — — — — — — — Fracture Injury, poisoning and procedural complications — — — — — — — — — — — — — — — — General disorders - Other, specify General disorders — — — — — — — — — — — — — — — — General disorders - Other, specify General disorders — — — — — — — — — — — — — — — — Generalized edema General disorders — — — — — — — — — — — — — — — — Hypertension Vascular disorders — — — — — — — — — — — — — — — — Infections and infestations - Other, specify Infections and infestations — — — — — — — — — — — — — — — — Injection site reaction General disorders — — — — — — — — — — — — — — — — Injection site reaction General disorders — — — — — — — — — — — — — — — — Injury, poisoning and procedural complications - Other, specify Injury, poisoning and procedural complications — — — — — — — — — — — — — — — — Kidney infection Infections and infestations — — — — — — — — — — — — — — — — Lung infection Infections and infestations — — — — — — — — — — — — — — — —
Most-reported serious reactions: Surgical and medical procedures - Other, specify , Anemia , Anxiety , Arthralgia , Back pain , Fall , Flu-like symptoms , Fracture .
Data from ClinicalTrials.gov NCT04641221 adverse events section .
Sponsor's own description
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. All participants will receive the core yoga intervention, with random assignment to the four intervention components outlined above.
2. Use results from Phase 2 to choose an efficient combination of intervention components that, together with standard yoga classes, maximizes yoga dosage.
3. Examine mechanisms by which components are hypothesized to work.
Publications & conference data
1 peer-reviewed publication reference this trial (live from Europe PMC):
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.
Uebelacker LA, Braun TD, Taylor LE, Saper R, et al ·
· 2024
· cited 1×
· PMID 38103784
· DOI 10.1016/j.cct.2023.107411
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Verify against primary sources
Data sources for this page
Trial protocol + status : ClinicalTrials.gov NCT04641221 (US National Library of Medicine, public domain)Publications : Europe PMC API search by NCT ID, retrieved 10 June 2026Drug + disease cross-links : matched in real time against Drug Landscape's normalised drug + company + condition tablesSponsor : as reported to ClinicalTrials.gov by Butler HospitalLast refreshed : 20 November 2025
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT04641221.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing
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