Mindfulness Oriented Recovery Enhancement for Chronic Pain and Opioid Relapse
2 other identifiers
interventional
154
1 country
1
Brief Summary
The objective of this study is to rigorously examine the impact of online MORE, delivered through video conference, on opioid use and chronic pain among individuals receiving methadone maintenance treatment (MMT). This study is a randomized controlled trial to test the efficacy of online MORE on opioid use and chronic pain immediately after treatment and 8-weeks post-treatment as compared to treatment as usual (TAU) among 154 individuals in MMT. Further, mediators (i.e., metacognitive awareness, negative emotion regulation, and natural reward processing) and moderators (i.e., gender, race, income, mental health, trauma, and MMT phase) of treatment response will be explored.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Aug 2020
Typical duration for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
July 9, 2020
CompletedFirst Posted
Study publicly available on registry
July 30, 2020
CompletedStudy Start
First participant enrolled
August 13, 2020
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 8, 2022
CompletedStudy Completion
Last participant's last visit for all outcomes
June 8, 2022
CompletedResults Posted
Study results publicly available
March 10, 2025
CompletedMarch 10, 2025
February 1, 2025
1.8 years
July 9, 2020
December 21, 2023
February 18, 2025
Conditions
Outcome Measures
Primary Outcomes (2)
Drug Relapse Through 16-weeks.
Drug use as measured by self-report through EMA, follow-back, or urine screen.
16-weeks
Methadone Treatment Drop Out Through 16-weeks.
Methadone treatment drop out as measured by clinic report.
16-weeks
Secondary Outcomes (7)
Number of Days of Any Drug Use
16-weeks
Number of Days of Opioid Use.
16-weeks
Number of Days of Other Drug Use.
16-weeks
Changes in Craving
16-weeks
Changes in Pain.
16-weeks
- +2 more secondary outcomes
Study Arms (2)
Mindfulness Oriented Recovery Enhancement
EXPERIMENTALThe Mindfulness Oriented Recovery Enhancement arm will participate in eight, weekly, two-hour group sessions.MORE sessions involve mindfulness training to prevent opioid relapse and reduce pain, cognitive reappraisal to decrease negative affect and regulate opioid craving, and savoring to augment natural reward processing and evoke positive emotion. Each session begins with a mindful breathing meditation, followed by a debriefing session. The therapist then debriefs participants' homework practice of using mindfulness, reappraisal, and savoring skills to cope with pain and enhance well-being in everyday life. During this debrief of the homework. Next, new psychoeducational material is introduced. Sessions culminate with an experiential exercise, and close with a brief mindful breathing meditation. Participants are asked to practice 15 minutes of mindfulness/reappraisal/savoring skills each day.
Methadone Treatment as Usual
OTHERIn the methadone programs, clients typically come to the clinic regularly to get their methadone dose. Clients see their clinic substance abuse counselor for individual counseling, usually weekly at the beginning of treatment, with decreasing frequency if they remain abstinent and progress through treatment. Depending on clients' stage of MMT and success with remaining abstinent from drugs, they may be required to attend clinic treatment groups. Also, some clients may choose to go to voluntary counseling, educational, or support groups.
Interventions
MORE sessions involve mindfulness training to prevent opioid relapse and reduce pain, cognitive reappraisal to decrease negative affect and regulate opioid craving, and savoring to augment natural reward processing and evoke positive emotion. Each session begins with a mindful breathing meditation, followed by a debriefing session. The therapist then debriefs participants' homework practice of using mindfulness, reappraisal, and savoring skills to cope with pain and enhance well-being in everyday life. During this debrief of the homework. Next, new psychoeducational material is introduced. Sessions culminate with an experiential exercise, and close with a brief mindful breathing meditation. Participants are asked to practice 15 minutes of mindfulness/reappraisal/savoring skills each day.
In the methadone programs, clients typically come to the clinic regularly to get their methadone dose. Clients see their clinic substance abuse counselor for individual counseling, usually weekly at the beginning of treatment, with decreasing frequency if they remain abstinent and progress through treatment. Depending on clients' stage of MMT and success with remaining abstinent from drugs, they may be required to attend clinic treatment groups. Also, some clients may choose to go to voluntary counseling, educational, or support groups.
Eligibility Criteria
You may qualify if:
- English-speaking
- Age ≥18
- Currently on methadone
- Experiencing non-malignant pain for a duration of 3 months or longer.
You may not qualify if:
- Severe cognitive impairment or active psychosis
- Suicide risk
- Inability to attend the MORE group, if randomized to that arm.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Rutgers Robert Wood Johnson Medical School
New Brunswick, New Jersey, 08901, United States
Related Publications (1)
Cooperman NA, Lu SE, Hanley AW, Puvananayagam T, Dooley-Budsock P, Kline A, Garland EL. Telehealth Mindfulness-Oriented Recovery Enhancement vs Usual Care in Individuals With Opioid Use Disorder and Pain: A Randomized Clinical Trial. JAMA Psychiatry. 2024 Apr 1;81(4):338-346. doi: 10.1001/jamapsychiatry.2023.5138.
PMID: 38061786DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Results Point of Contact
- Title
- Dr. Nina Cooperman, Associate Professor
- Organization
- Rutgers Robert Wood Johnson Medical School
Study Officials
- PRINCIPAL INVESTIGATOR
Nina Cooperman, PsyD
Rutgers Robert Wood Johnson Medical School
Publication Agreements
- PI is Sponsor Employee
- Yes
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Associate Professor
Study Record Dates
First Submitted
July 9, 2020
First Posted
July 30, 2020
Study Start
August 13, 2020
Primary Completion
June 8, 2022
Study Completion
June 8, 2022
Last Updated
March 10, 2025
Results First Posted
March 10, 2025
Record last verified: 2025-02
Data Sharing
- IPD Sharing
- Will share
- Shared Documents
- STUDY PROTOCOL, SAP, ICF, CSR, ANALYTIC CODE
- Time Frame
- Beginning 3 months and ending 36 months after study publication.
- Access Criteria
- Data and associated documentation will be available to research community scientists only under a data-sharing agreement that provides for: (1) a commitment to using the data only for research purposes and not to identify any individual participant; (2) a commitment to securing the data using appropriate computer technology; and (3) a commitment to destroying or returning the data after analyses are completed.
Analyses of data generated from this project will be shared with the scientific community through publications in peer-reviewed journals and presentations at scientific meetings. The proposed research will include data from approximately 154 individuals in methadone maintenance treatment. The final dataset will include self-reported demographic and behavioral data from interviews with the subjects and laboratory data from urine or saliva specimens provided. Because we will be following study participants, we will be collecting identifying information. The final dataset will be stripped of identifiers prior to release for sharing.