Number of Participants Recruited
Primary
· 4 months
As this is a pilot study, a key outcome is number of participants recruited
| Group | Value | 95% CI |
|---|---|---|
| Entire Study | 20 |
Last reviewed · How we verify
NCT04646148: YOGAMAT-II
Optimization and Multi-Site Feasibility of Yoga for Chronic Pain in People in YOGAMAT-II - Phase I
Completed
NA
Results posted
Last updated 14 September 2022
What this trial tests
NA trial testing Yoga classes in Opioid Use in 20 participants. Completed in 1 November 2021.
Timeline
1 March 2021
Primary endpoint
1 November 2021
1 November 2021
1 November 2021
Quick facts
| Lead sponsor | Butler Hospital |
|---|---|
| Phase | NA |
| Status | Completed |
| Study type | INTERVENTIONAL |
| Allocation | randomized |
| Design | factorial |
| Masking | double |
| Primary purpose | other |
| Enrollment | 20 |
| Start date | 1 March 2021 |
| Primary completion | 1 November 2021 |
| Estimated completion | 1 November 2021 |
| Sites | 2 locations across United States |
Drugs / interventions tested
- Yoga classes
Conditions studied
- Opioid Use — all drugs for Opioid Use →
- Chronic Pain — all drugs for Chronic Pain →
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.
Number of Yoga Teachers Trained to > 80% Fidelity to the Manual
Primary
· 7 months
As this is a pilot study, an outcome is to assess whether we can train teachers to an acceptable level of fidelity
| Group | Value | 95% CI |
|---|---|---|
| Entire Study | 4 |
Percent of Weeks Where Data on Amount of Yoga Personal Practice Were Collected
Primary
· 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.)
| Group | Value | 95% CI |
|---|---|---|
| No Video/No One-on-One/No Text/Yes Incentive | 100 | ± 0 |
| No Video/No One-on-One/Yes Text/Yes Incentive | 100 | ± 0 |
| No Video/Yes One-on-One/No Text/No Incentive | 8.3 | ± 0 |
| No Video/Yes One-on-One/No Text/Yes Incentive | 62.5 | ± 53.03 |
| No Video/Yes One-on-One/Yes Text/No Incentive | 100 | ± 0 |
| No Video/Yes One-on-One/Yes Text/Yes Incentive | 58.3 | ± 58.92 |
| Yes Video/No One-on-One/No Text/No Incentive | 100 | ± 0 |
| Yes Video/No One-on-One/No Text/Yes Incentive | 100 | ± 0 |
| Yes Video/No One-on-One/Yes Text/No Incentive | 100 | ± 0 |
| Yes Video/No One-on-One/Yes Text/Yes Incentive | 100 | ± 0 |
| Yes Video/Yes One-on-One/No Text/No Incentive | 100 | ± 0 |
| Yes Video/Yes One-on-One/No Text/Yes Incentive | 100 | ± 0 |
Adverse events — posted to ClinicalTrials.gov
Time frame: 3 months -- this is the length of time that any one participant was enrolled in the study.. Reporting threshold: 5%. 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: 0
Deaths: 0
No Video/No One-on-One/No Text/Yes Incentive
Serious: 0/1 (0%)
Deaths: 0/1
No Video/No One-on-One/Yes Text/No Incentive
Serious: 0
Deaths: 0
No Video/No One-on-One/Yes Text/Yes Incentive
Serious: 0/1 (0%)
Deaths: 0/1
No Video/Yes One-on-One/No Text/No Incentive
Serious: 0/1 (0%)
Deaths: 0/1
No Video/Yes One-on-One/No Text/Yes Incentive
Serious: 0/2 (0%)
Deaths: 0/2
No Video/Yes One-on-One/Yes Text/No Incentive
Serious: 0/1 (0%)
Deaths: 0/1
No Video/Yes One-on-One/Yes Text/Yes Incentive
Serious: 0/2 (0%)
Deaths: 0/2
Yes Video/No One-on-One/No Text/No Incentive
Serious: 0/1 (0%)
Deaths: 0/1
Yes Video/No One-on-One/No Text/Yes Incentive
Serious: 0/2 (0%)
Deaths: 0/2
Yes Video/No One-on-One/Yes Text/No Incentive
Serious: 0/1 (0%)
Deaths: 0/1
Yes Video/No One-on-One/Yes Text/Yes Incentive
Serious: 0/2 (0%)
Deaths: 0/2
Yes Video/Yes One-on-One/No Text/No Incentive
Serious: 0/1 (0%)
Deaths: 0/1
Yes Video/Yes One-on-One/No Text/Yes Incentive
Serious: 0/1 (0%)
Deaths: 0/1
Yes Video/Yes One-on-One/Yes Text/No Incentive
Serious: 0/2 (0%)
Deaths: 0/2
Yes Video/Yes One-on-One/Yes Text/Yes Incentive
Serious: 0/2 (0%)
Deaths: 0/2
Other adverse events (4 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… |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Arthralgia | Musculoskeletal and connective tissue disorders | — | — | — | — | — | — | — | — | — | — | — | — | — | — | — | — |
| Back pain | Musculoskeletal and connective tissue disorders | — | — | — | — | — | — | — | — | — | — | — | — | — | — | — | — |
| Edema in limbs | General disorders | — | — | — | — | — | — | — | — | — | — | — | — | — | — | — | — |
| Pain in extremity | Musculoskeletal and connective tissue disorders | — | — | — | — | — | — | — | — | — | — | — | — | — | — | — | — |
Data from ClinicalTrials.gov NCT04646148 adverse events section.
Sponsor's own description
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. 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.
Publications & conference data
No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.
Verify or expand the search:
- PubMed search for NCT04646148
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
Related trials
Other recruiting trials for Opioid Use
Currently open trials in the same condition.
- NCT07342504 — Better Experiences in Substance Treatment: A Brief Alcohol-focused Intervention Tailored for Patients in Opioid Agonist · NA · recruiting
- NCT07004686 — Effect of MGRNOX-Guided General Anesthesia on Opioid Consumption in Patients · NA · recruiting
- NCT06981195 — Effects of Lemborexant on Insomnia and Its Relationship to Mood and Behavior on Opioid Use Disorder Subjects · Phase 2 · recruiting
- NCT06806163 — Machine-Learning Prediction and Reducing Overdoses With EHR Nudges · NA · recruiting
- NCT06909851 — Comparison of Pain Relief After Arthroscopic Knee Surgery: Adductor Canal Block and Genicular Nerve Block · NA · recruiting
Other Butler Hospital trials
Trials by the same sponsor.
- NCT07404618 — Video Intervention for Older Adults With Chronic Pain · NA · not yet recruiting
- NCT06880796 — Mindfulness-Based Therapy for Serious Mental Illness · NA · enrolling by invitation
- NCT07195019 — Women's Wellbeing Study · NA · recruiting
- NCT06657950 — Treatments for Improving Mood in Women Survivors of Interpersonal Violence: A Community-Engaged Study-1.2 · NA · completed
- NCT05180344 — Feasibility, Acceptability, and Preliminary Efficacy of a Novel Personalized Mobile Intervention for Suicide - Open Tria · NA · recruiting
Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
Data sources for this page
- Trial protocol + status: ClinicalTrials.gov NCT04646148 (US National Library of Medicine, public domain)
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by Butler Hospital
- Last refreshed: 14 September 2022
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/NCT04646148.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing