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COMPLETED NA

Effect of Mindfulness on Opioid Use and Anxiety During Primary Care Buprenorphine Treatment (R33 Phase)

NCT04278586 · View on ClinicalTrials.gov ↗

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).

Interventions

  • BEHAVIORAL Live-Online M-ROCC
  • BEHAVIORAL Live-Online Control

Study Locations (1)

Massachusetts

  • Cambridge Health Alliance — Somerville

Trial Details

FieldValue
Enrollment Target 260 participants
Start Date 2021-02-15
Est. Completion 2023-09-19
Phase NA

Sponsor

Cambridge Health Alliance

12 total trials

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Full Details on ClinicalTrials.gov ↗

What the Registry Record Tells You About NCT04278586

The ClinicalTrials.gov registry entry for NCT04278586 describes a study currently listed as completed. It is categorized as NA, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 260 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Cambridge Health Alliance, which has 12 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.

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. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.

Geographic footprint matters for practical reasons: NCT04278586 reports 1 study location spanning 1 distinct geographic area — top geographies include Massachusetts. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.

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. These conditions were identified from the trial registry and reflect the primary focus areas of the research.

What interventions are being tested in trial NCT04278586?

The interventions under investigation include: Live-Online M-ROCC (BEHAVIORAL), Live-Online Control (BEHAVIORAL). Each intervention is being evaluated for safety and efficacy as part of this clinical study.

Who is sponsoring clinical trial NCT04278586?

This trial is sponsored by Cambridge Health Alliance, which has 12 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.

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.

Related

Data sourced from official U.S. government datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial