Pilot of Mindfulness Oriented Recovery Enhancement in MethadoneTreatment
Mindfulness Oriented Recovery Enhancement as an Adjunct to Methadone Treatment for Opioid Use and Chronic Pain Management Pilot
1 other identifier
interventional
30
1 country
1
Brief Summary
This pilot study aims to evaluate the impact of a novel intervention, Mindfulness Oriented Recovery Enhancement (MORE), on opioid use and chronic pain among individuals receiving methadone maintenance treatment (MMT). The main goal of this pilot study is to test the feasibility of our study methods before conducting a clinical trial to assess MORE with respect to a range of clinical outcomes. This study will involve a 2-arm individually randomized controlled trial design that compares MORE and treatment as usual (TAU).
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable
Started Jan 2019
Shorter than P25 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
January 31, 2019
CompletedFirst Submitted
Initial submission to the registry
March 26, 2019
CompletedFirst Posted
Study publicly available on registry
March 28, 2019
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 19, 2019
CompletedStudy Completion
Last participant's last visit for all outcomes
June 19, 2019
CompletedResults Posted
Study results publicly available
January 11, 2022
CompletedJanuary 11, 2022
November 1, 2021
5 months
March 26, 2019
May 19, 2021
November 9, 2021
Conditions
Keywords
Outcome Measures
Primary Outcomes (15)
Study Interest
The number of individuals who express interest in the study.
Baseline
Study Refusal
The number of individuals who who refuse participation when offered.
Baseline
Individuals Screened
The number of individuals screened and eligible/ineligible.
Baseline (study enrollment)
Individuals Consented.
The number of individuals consented.
Baseline (study enrollment)
Refusal After/During Consent Process.
The number of individuals who refuse participation after/during consent process.
Enrollment
Mean Sessions Completed
The mean number of sessions completed by study participants in the MORE intervention.
At 8-weeks (post treatment period completion).
Percentage of Sessions Completed
The mean percentage of sessions completed by study participants randomized to MORE.
At 8-weeks (post treatment period completion).
Number Who Drop Out
Number of participants who drop out of the study.
At 16 weeks.
Percentage Who Drop Out
Percentage of participants who drop out of the study.
At 16 weeks.
Baselines Completed
The number of participants who complete baseline assessments.
At baseline,
Percentage Baselines Completed
Percentage of people who completed baseline assessments.
At baseline,
8-weeks Completed
The number of participants who complete 8-week assessments.
At 8-weeks.
Percentage 8-Weeks Completed
Percentage of participants who completed 8-week assessments.
At 8-weeks.
16-Weeks Completed
The number of participants who completed 16-week assessments.
At 16-weeks.
Percentage of 16-Weeks Completed
Percentage of participants who completed 16-week assessments.
At 16-weeks.
Secondary Outcomes (6)
Days of Illicit Drug Use
16-weeks
Days of Illicit Opioid Use
16-weeks
Opioid Craving
16-weeks
Pain Level.
16-weeks
Depression Level.
16-weeks
- +1 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 program behavioral 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:
- Age 18 or older
- English-speaking
- Been in methadone treatment for at least 3 months
- Experience a non-malignant pain (with an intensity level of 8 or higher on the Gracely Box Scale) for a duration of 2 months or longer.
You may not qualify if:
- Exhibit cognitive impairment (score \<24 on the Mini Mental Status Exam)
- Exhibit psychosis (positive SCID Psychotic Screen),
- Are at suicidal risk (positive score on ASQ Suicide Risk Screening Tool)
- Unable to attend group sessions due to distance, work, commitments or other logistical problems,
- Are currently pregnant or breastfeeding
- Are planning to be pregnant or breastfeeding the next 16 weeks.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Rutgers, The State University of New Jerseylead
- University of Utahcollaborator
Study Sites (1)
Rutgers Robert Wood Johnson Medical School
New Brunswick, New Jersey, 08901, United States
Related Publications (1)
Garland EL, Hanley AW, Kline A, Cooperman NA. Mindfulness-Oriented Recovery Enhancement reduces opioid craving among individuals with opioid use disorder and chronic pain in medication assisted treatment: Ecological momentary assessments from a stage 1 randomized controlled trial. Drug Alcohol Depend. 2019 Oct 1;203:61-65. doi: 10.1016/j.drugalcdep.2019.07.007. Epub 2019 Aug 5.
PMID: 31404850RESULT
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Results Point of Contact
- Title
- Nina Cooperman
- Organization
- Rutgers Robert Wood Johnson Medical School
Study Officials
- PRINCIPAL INVESTIGATOR
Nina A Cooperman, PsyD
Rutgers Robert Wood Johnson Medical School
Publication Agreements
- PI is Sponsor Employee
- No
- Restrictive Agreement
- No
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Associate Professor
Study Record Dates
First Submitted
March 26, 2019
First Posted
March 28, 2019
Study Start
January 31, 2019
Primary Completion
June 19, 2019
Study Completion
June 19, 2019
Last Updated
January 11, 2022
Results First Posted
January 11, 2022
Record last verified: 2021-11
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
- We will make the data and associated documentation 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 30 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 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.