Implementation and Effectiveness of Mindfulness Oriented... | NCT06032559

Studies
Implementation and Effectiveness of Mindfulness Oriented Recovery Enhancement as an Adjunct to Methadone Treatment

NCT06032559

Sponsor

Rutgers, The State University of New Jersey

Status

Recruiting

Last Update Posted

Jul 30, 2025Actual

Enrollment

450Estimated

Phase

Phase 3

Conditions

Opioid Use
Pain

Interventions

Countries

United States

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

ID	Type	Description	Link
R01DA056537	U.S. NIH Grant/Contract		View source

Status Module

Record Verification Date

Jul 2025

Overall Recruitment Status or Expanded Access Status

Recruiting

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Sep 4, 2023Actual

Primary Completion Date

May 31, 2027Estimated

Completion Date

Jul 31, 2027Estimated

First Submitted Date

Sep 4, 2023

First Submission Date that Met QC Criteria

Sep 4, 2023

First Posted Date

Sep 13, 2023Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jul 29, 2025

Last Update Posted Date

Jul 30, 2025Actual

Sponsor/Collaborators Module

Responsible Party, by Official Title

Nina A. Cooperman, Psy. D., Associate Professor, Rutgers, The State University of New JerseyPrincipal Investigator

Lead Sponsor

Rutgers, The State University of New JerseyOTHER

Collaborators

Name	Class
National Institute on Drug Abuse (NIDA)	NIH
University of Utah	OTHER

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

FDAAA801 Violation

Not provided

Description Module

Brief Summary

This hybrid implementation-effectiveness trial will evaluate Mindfulness-Oriented Recovery Enhancement (MORE) for patients with opioid use disorder receiving methadone treatment (MT). The investigators will also assess barriers and facilitators to integrating MORE into methadone treatment, and evaluate the impact of a sustainable train-the-trainer model on provider burden, intervention fidelity, intervention engagement, and outcomes. Participants will be assigned to a higher intensity MORE implementation strategy, a minimal intensity implementation strategy consisting of a simple, scripted mindfulness practice (SMP) extracted from the MORE treatment manual with minimal training and feedback and no supervision, or methadone treatment as usual (TAU). We aim to:

Examine barriers and facilitators to the implementation of MORE and SMP in MT and evaluate strategies for optimizing training, fidelity, and engagement.
Evaluate the effectiveness and treatment fidelity of a higher intensity MORE implementation strategy versus a lower intensity, scripted mindfulness practice (SMP) implementation strategy as an adjunct to methadone TAU or methadone TAU, only. Outcomes include opioid and other drug use, craving, MT discontinuation, depression, anxiety, and physical pain (secondary outcomes) than patients randomized to TAU.

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 3

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

450Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
MORE	Experimental	Eight group sessions of Mindfulness-Oriented Recovery Enhancement plus methadone treatment as usual (TAU)	Behavioral: MORE
Scripted Mindfulness Practice (SMP)	Active Comparator	Eight group sessions of scripted mindfulness practice plus TAU.	Behavioral: SMP
Treatment-as-Usual	Active Comparator	Methadone treatment as usual.	Other: TAU

Interventions

Name	Type	Description	Arm Group Labels	Other Names
MORE	Behavioral	MORE plus TAU	MORE
SMP

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Days of drug use	mber of days of drug use as measured by self-reported days of use and biochemically verified use via drug screen.	Baseline through 52 weeks

Secondary Outcomes

Measure	Description	Time Frame
Chronic Pain	Chronic pain measured by the Brief Pain Inventory Short Form (range 0-10, with higher scores indicating worse pain).	Baseline through 52 weeks

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

English-speaking
age ≥18
currently on methadone
persistent or recurring pain that has lasted for a duration of 3 months of longer.

Exclusion Criteria:

severe cognitive impairment (score >23 on Mini Mental Status Exam) or psychosis (positive SCID Psychotic Screen)
suicidal risk (score ≥7 on Suicidal Behaviors Questionnaire)
inability to attend or fully participate in intervention sessions or assessments
previous formal mindfulness training (e.g., MBSR, MBRP) or MORE (from the R21 or R33 studies).

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Nina Cooperman, PsyD	Contact	732-235-8569		cooperna@rwjms.rutgers.edu
Eric Garland, PhD	Contact	801-581-3826		eric.garland@socwk.utah.edu

Overall Officials

Name	Affiliation	Role
Eric Garland, Ph	Rutgers Robert Wood Johnson Medical School	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Rutgers Robert Wood Johnson Medical School	Recruiting	New Brunswick	New Jersey	08901	United States

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
38907675	Derived	Cooperman NA, Shen J, Gordon AJ, Garland EL. Commentary With Study Protocol: Implementation and Effectiveness of Mindfulness-Oriented Recovery Enhancement (MORE) as an Adjunct to Methadone Treatment for Opioid Use Disorder (IMPOWR-MORE). Subst Use Addctn J. 2025 Jan;46(1):160-165. doi: 10.1177/29767342241261890. Epub 2024 Jun 22.

ID	Term
D009461	Neurologic Manifestations
D012816	Signs and Symptoms
D013568	Pathological Conditions, Signs and Symptoms