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NCT04278586 · ClinicalTrials.gov registry record · NA
Effect of Mindfulness on Opioid Use and Anxiety During Primary Care Buprenorphine Treatment (R33 Phase)
A NA study of Anxiety and Opioid Use Disorder, sponsored by Cambridge Health Alliance.
- Completed
- Registry status
- NA
- Development phase
- 260
- Enrollment target
- 1
- Study location
NCT04278586: Completed NA study of Anxiety and Opioid Use Disorder, sponsored by Cambridge Health Alliance.
NCT04278586 is a NA study of Anxiety and Opioid Use Disorder that has completed, run by Cambridge Health Alliance. The registered enrollment target is 260 participants, below the 439-participant average among 364 other Anxiety trials with a reported enrollment target (41% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT04278586, a NA study of Anxiety and Opioid Use Disorder, has completed, sponsored by Cambridge Health Alliance.
- COMPLETED
- Registry status
- NA
- Development phase
- 260 participants
- Enrollment target
- 1
- Study location
Study Summary
This will be a randomized controlled trial (RCT) designed to compare live-online Mindful Recovery Opioid Care Continuum (M-ROCC) groups with a live-online control group on the primary outcome of number of biochemically confirmed opioid negative abstinent periods (defined by a negative oral fluid test \[negative for opiate, oxycodone, fentanyl, methadone\] AND no self-reported illicit opioid use) during the final six two-week periods of the study (study weeks 13-24).
Primary Outcome
Biochemically-confirmed opioid abstinence, which is defined as the number of two-week periods with a negative oral fluid screen AND no opioid use reported in weekly self report self-report during the final 12 weeks (weeks 13-24) of the study (6 is the highest possible number of negative oral fluid toxicology screen time periods). Participants will be randomly selected to undergo a live-online supervised oral fluid screen at a rate of once every 2 weeks.
Conditions Studied
Interventions
- BEHAVIORAL Live-Online M-ROCC
- BEHAVIORAL Live-Online Control
Study Locations (1)
Massachusetts
- Cambridge Health Alliance - Somerville
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 260 participants |
| Start Date | 2021-02-15 |
| Est. Completion | 2023-09-19 |
| Phase | NA |
What the finished NCT04278586 record still lists
NCT04278586 is an interventional study that assigns participants to a tested intervention. The registered 260 participants enrollment target is mid-sized for trials with a published cap, below the 439-participant average among 364 other Anxiety trials with a reported enrollment target (41% lower).
The record links to 4 conditions, with Anxiety appearing as the primary indexed condition, and to 2 interventions - of which Live-Online M-ROCC is the first listed.
NCT04278586 reports a single indexed study location in Massachusetts.
Frequently Asked Questions
What is clinical trial NCT04278586 about?
NCT04278586 is a clinical study titled "Effect of Mindfulness on Opioid Use and Anxiety During Primary Care Buprenorphine Treatment (R33 Phase)". This will be a randomized controlled trial (RCT) designed to compare live-online Mindful Recovery Opioid Care Continuum (M-ROCC) groups with a live-online control group on the primary outcome of number of biochemically confirmed opioid negative abstinent periods (defined by a negative oral fluid tes...
What is the current status of trial NCT04278586?
This trial is currently completed. It is a NA study. The enrollment target is 260 participants. The study started on 2021-02-15. Estimated completion is 2023-09-19.
What conditions does trial NCT04278586 study?
This clinical trial studies the following conditions: Anxiety, Opioid Use Disorder, Stress Related Disorder, Pain Interference.
What interventions are being tested in trial NCT04278586?
The interventions under investigation include: Live-Online M-ROCC (BEHAVIORAL), Live-Online Control (BEHAVIORAL).
Who is sponsoring clinical trial NCT04278586?
This trial is sponsored by Cambridge Health Alliance, which has 45 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT04278586 being conducted?
This trial has 1 study location across Massachusetts. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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Where NCT04278586's enrollment target sits among peer trials
260 67th of 364 higher than 298 of 364 other Anxiety trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Anxiety trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
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