Adults 18 to 70, any sex, with Opioid-use Disorder or Stress Related Disorder. 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 Biochemically-confirmed Opioid Abstinent 2-week Time PeriodsPrimary· Weeks 13-24
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.
Group
Value
95% CI
Live-Online Mindful Recovery OUD Care Continuum
13.4
6.2 – 20.5
Live-Online Control
12.7
7.5 – 18.0
Number of Positive Oral-fluid Toxicology Tests for Cocaine.Secondary· Weeks 13-24
Biochemically-confirmed cocaine use, which is defined as the number of two-week periods with a positive oral-fluid screen. Oral-fluid toxicology screens will be conducted 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.
Group
Value
95% CI
Live-Online Mindful Recovery OUD Care Continuum
8.4
0 – 16.6
Live-Online Control
1.5
0 – 4.0
Number of Positive Oral-fluid Toxicology Tests for Benzodiazepines.Secondary· Weeks 13-24
Biochemically-confirmed benzodiazepine use, which is defined as the number of two-week periods with a positive oral-fluid screen. Oral-fluid toxicology screens will be conducted 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.
Group
Value
95% CI
Live-Online Mindful Recovery OUD Care Continuum
22.1
12.7 – 31.5
Live-Online Control
20.2
12.7 – 27.7
Patient Report Outcomes Measurement Information System - Anxiety Short Form 8a (PROMIS-ASF)Secondary· 24 Weeks
The Patient Reported Outcomes Measurement Information System - Anxiety Short Form 8a (PROMIS-ASF) is an 8-item scale from 7-35 used to assess patient-reported health status for anxiety. Subjects are asked to rate their experience of the item in the past seven days on a 5-point scale from 1 (Never) to 5 (Always). Higher ratings indicate greater anxiety symptoms while lower ratings indicate less anxiety symptoms. This will be assessed among participants with an anxiety disorder (defined as PROMIS \>55 at baseline) as well at weeks 8, 16, and 24.
The PROMIS Pain Interference instruments measure the self-reported consequences of pain on relevant aspects of one's life. This includes the extent to which pain hinders engagement with social, cognitive, emotional, physical, and recreational activities. The Pain Interference short form is universal rather than disease-specific. It assesses pain interference over the past seven days. Each question has five response options ranging in value from one to five with a total scale range of 7-35. Higher ratings indicate greater pain interference and lower ratings indicate lesser pain interference. Th
The Substance Craving Scale (SUBCS) is a 6-item scale with a range of 0-60. It includes the 3-item validated Opioid Craving Scale (OCS) as the primary measure with a 0-30 scale based on opioids. The SUBCS adds another 3 items based on other non-opioids substances. The OCS assesses participant craving for Opioids (including fentanyl, heroin, methadone, oxycodone or other opioids) and the (SUBCS) includes the OCS plus other substance use (including illicit drugs \[e.g., cocaine, methamphetamine, etc.\], using unprescribed pills or prescribed medications in ways or at doses for which they were no
Group
Value
95% CI
Live-Online Mindful Recovery OUD Care Continuum
-2.3
-2.9 – -1.7
Live-Online Control
-1.3
-1.9 – -0.8
Adverse events — posted to ClinicalTrials.gov
Time frame: Adverse event data were collected over the 24 weeks that participants were in the study..
Reporting threshold: 0%.
Adverse-event reports describe events observed during the trial — not all are caused by the drug.
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).
Publications & conference data
5 peer-reviewed publications reference this trial (live from Europe PMC):
NCT04783558 — Effective Caregiving for Neonatal Abstinence Syndrome: Testing an Instructional Mobile Technology Platform for High-Risk
· NA
· active not recruiting
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· recruiting
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· recruiting
NCT04738825 — Promoting HIV Risk Reduction Among People Who Inject Drugs: A Stepped Care Approach Using Contingency Management With Pr
· NA
· recruiting
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Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by Cambridge Health Alliance
Last refreshed: 22 July 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/NCT04278586.