Mindfulness Oriented Recovery Enhancement for Chronic Pain and Opioid Relapse

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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Mindfulness Oriented Recovery Enhancement for Chronic Pain and Opioid Relapse as an Adjunct to Methadone Treatment

Conditions
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Opioid Use, Chronic Pain

Intervention / Treatment
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* Behavioral: Mindfulness Oriented Recovery Enhancement
* Other: Methadone Treatment as Usual


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Two-arm randomized controlled trial.
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Mindfulness Oriented Recovery Enhancement<br>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. | Behavioral: Mindfulness Oriented Recovery Enhancement<br>* 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.<br>* Other names: MORE;|
| Other: Methadone Treatment as Usual<br>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: Methadone Treatment as Usual<br>* 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.<br>* Other names: MMT, Treatment as Usual, TAU;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Opioid relapse through 16-weeks. | Number of days until first opioid use as measured by self-report through EMA, follow-back, or urine screen. | 16-weeks | 
| Methadone treatment retention through 16-weeks. | Number of days to methadone dosing lapse or discontinuation as measured by EMA, follow-back, clinic charts, or urine screen. | 16-weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Opioid abstinence versus any opioid use. | 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. | 8-weeks | 
| Opioid abstinence versus any opioid use. | Used opioids or not as measured by self-report through EMA or timeline follow-back and verified by urine or saliva drug screen. | 16-weeks | 
| Other drug abstinence versus other drug use. | Used other drugs or not as measured by self-report through EMA or timeline follow-back and verified by urine or saliva drug screen. | 8-weeks | 
| Other drug abstinence versus other drug use. | Uses other drugs or not as measured by self-report through EMA or timeline follow-back and verified by urine or saliva drug screen. | 16-weeks | 
| Number of days of opioid use. | 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. | 8-weeks | 
| Number of days of opioid use. | 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. | 16-weeks | 
| Number of days of other drug use. | 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. | 16-weeks | 
| Craving level. | Penn Alcohol Craving Scale score on a range from 0 (e.g., no craving) to 6 (intense craving) or EMA. | 8-weeks | 
| Craving level. | Penn Alcohol Craving Scale score on a range from 0 (e.g., no craving) to 6 (intense craving) or EMA . | 16-weeks | 
| Pain level. | Brief Pain Inventory score on a scale from 0 (no pain) to 10 (pain as bad as you can imagine) or EMA. | 8-weeks | 
| Pain level. | Brief Pain Inventory score on a scale from 0 (no pain) to 10 (pain as bad as you can imagine) or EMA. | 16-weeks | 
| Emotional Distress | 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. | 8-weeks | 
| Emotional Distress | 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. | 16-weeks | 
| Positive Affect. | Positive feelings on a scale from 0 (not at all positive) to 10 (very positive) | 8-weeks | 
| Positive Affect. | Positive feelings on a scale from 0 (not at all positive) to 10 (very positive) | 16-weeks. |