- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04491968
Mindfulness Oriented Recovery Enhancement for Chronic Pain and Opioid Relapse
Mindfulness Oriented Recovery Enhancement for Chronic Pain and Opioid Relapse as an Adjunct to Methadone Treatment
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
This study is a 2-arm individually randomized controlled trial design in which outcomes of MMT patients randomized to MORE are compared to outcomes of those randomized to treatment as usual (TAU). In this study (N=154), the investigators will randomize MMT patients with chronic pain to MORE (n=77) or TAU (n=77). The purpose of this study is to determine MORE's efficacy for increasing opioid abstinence relative to TAU. Individuals with pain who are receiving MMT for an opioid use disorder (OUD) will be recruited from two methadone clinics in New Jersey.
Participants will be recruited through flyers posted in the clinics, being approached by research assistants in the waiting room of their usual methadone clinic, and referral by clinic staff. The number of individuals who contact the study staff through the flyers or referral and who are approached by study staff in the clinics will be tracked. Number of individuals who refuse study participation and who consent to the study will also be tracked. If an individual is interested in study participation, a trained research assistant will lead the individual through the informed consent process in a private space.
Since MORE is a closed group, the cohorts of 14 participants at each site will be randomized to TAU or MORE. Once 14 participants at a particular clinic are enrolled and randomized the MORE group will begin.
Participants randomized to the MORE condition will participate in eight, weekly, two-hour group sessions, co-led by a clinic and study counselor. Each session will contain 7 participants and take place remotely, by video conference. Attendance at each session and reasons for missing sessions will be recorded. Participants randomized to the control condition will continue receiving treatment as usual.
All study participants will partake in a total of three interviews lasting up to 90 minutes and occurring, remotely, at baseline, 8- and 16- weeks post-baseline by telephone or video conference. Each participant will also complete a urine or saliva drug screen at each assessment. All attempts to reach participants to schedule follow-up assessments will be tracked. Participants will also complete cognitive testing (for approx. 30-45 minutes) at baseline and 8-weeks and ecological momentary assessments (EMA) conducted via smartphones or tablets, which will be provided to each participant by study staff. EMA participation will require the participant to respond to twice-daily prompts in which they will be asked a series of brief questions regarding their current mood and exposure to opioid triggers. Additionally, subjects will be asked to initiate responses when they experience serious craving or relapse to opioid use. Each EMA assessment will last approximately 3-5 minutes.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
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New Jersey
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New Brunswick, New Jersey, United States, 08901
- Rutgers Robert Wood Johnson Medical School
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- English-speaking
- Age ≥18
- Currently on methadone
- Experiencing non-malignant pain for a duration of 3 months or longer.
Exclusion Criteria:
- Severe cognitive impairment or active psychosis
- Suicide risk
- Inability to attend the MORE group, if randomized to that arm.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Mindfulness Oriented Recovery Enhancement
The 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.
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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.
Other Names:
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Other: Methadone Treatment as Usual
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.
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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.
Other Names:
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Opioid relapse through 16-weeks.
Time Frame: 16-weeks
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Number of days until first opioid use as measured by self-report through EMA, follow-back, or urine screen.
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16-weeks
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Methadone treatment retention through 16-weeks.
Time Frame: 16-weeks
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Number of days to methadone dosing lapse or discontinuation as measured by EMA, follow-back, clinic charts, or urine screen.
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16-weeks
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Opioid abstinence versus any opioid use.
Time Frame: 8-weeks
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Used opioids or not at 8-weeks as measured by self-report through EMA or timeline follow-back and verified by urine or saliva drug screen.
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8-weeks
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Opioid abstinence versus any opioid use.
Time Frame: 16-weeks
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Used opioids or not as measured by self-report through EMA or timeline follow-back and verified by urine or saliva drug screen.
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16-weeks
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Other drug abstinence versus other drug use.
Time Frame: 8-weeks
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Used other drugs or not as measured by self-report through EMA or timeline follow-back and verified by urine or saliva drug screen.
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8-weeks
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Other drug abstinence versus other drug use.
Time Frame: 16-weeks
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Uses other drugs or not as measured by self-report through EMA or timeline follow-back and verified by urine or saliva drug screen.
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16-weeks
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Number of days of opioid use.
Time Frame: 8-weeks
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Number of days of opioid use as measured by self-report through EMA or timeline follow-back and verified by urine or saliva drug screen.
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8-weeks
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Number of days of opioid use.
Time Frame: 16-weeks
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Number of days of opioid use as measured by self-report through EMA or timeline follow-back and verified by urine or saliva drug screen.
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16-weeks
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Number of days of other drug use.
Time Frame: 16-weeks
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Number of days of other drug use as measured by self-report through EMA or timeline follow-back and verified by urine or saliva drug screen.
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16-weeks
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Craving level.
Time Frame: 8-weeks
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Penn Alcohol Craving Scale score on a range from 0 (e.g., no craving) to 6 (intense craving) or EMA.
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8-weeks
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Craving level.
Time Frame: 16-weeks
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Penn Alcohol Craving Scale score on a range from 0 (e.g., no craving) to 6 (intense craving) or EMA .
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16-weeks
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Pain level.
Time Frame: 8-weeks
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Brief Pain Inventory score on a scale from 0 (no pain) to 10 (pain as bad as you can imagine) or EMA.
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8-weeks
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Pain level.
Time Frame: 16-weeks
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Brief Pain Inventory score on a scale from 0 (no pain) to 10 (pain as bad as you can imagine) or EMA.
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16-weeks
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Emotional Distress
Time Frame: 8-weeks
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Beck Anxiety Inventory score on a scale from 0 (no anxiety) to 63 (severe anxiety) and Center for Epidemiology Scale for Depression scored on a scale from 0 (no depression) to 60 (severe depression) or EMA.
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8-weeks
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Emotional Distress
Time Frame: 16-weeks
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Beck Anxiety Inventory score on a scale from 0 (no anxiety) to 63 (severe anxiety) and Center for Epidemiology Scale for Depression scored on a scale from 0 (no depression) to 60 (severe depression) or EMA.
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16-weeks
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Positive Affect.
Time Frame: 8-weeks
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Positive feelings on a scale from 0 (not at all positive) to 10 (very positive)
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8-weeks
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Positive Affect.
Time Frame: 16-weeks.
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Positive feelings on a scale from 0 (not at all positive) to 10 (very positive)
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16-weeks.
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Collaborators and Investigators
Collaborators
Investigators
- Principal Investigator: Nina Cooperman, PsyD, Rutgers Robert Wood Johnson Medical School
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- R33 AT01009
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
IPD Sharing Time Frame
IPD Sharing Access Criteria
IPD Sharing Supporting Information Type
- Study Protocol
- Statistical Analysis Plan (SAP)
- Informed Consent Form (ICF)
- Clinical Study Report (CSR)
- Analytic Code
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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