Pilot of Mindfulness Oriented Recovery Enhancement in MethadoneTreatment

Study Overview
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Brief Summary
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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).

Detailed Description
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This pilot 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 the pilot study (R21; N=30), we will randomize MMT patients with chronic pain to MORE (n=15) or TAU (n=15). This study phase will focus on establishing study feasibility in recruiting, retaining, and following up study participants before progressing to a larger Phase II clinical trial (R33, N=150). Participants 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, we will randomize cohorts of 14-16 participants (depending on speed of recruitment) at each site to TAU or MORE with block randomization. Once we 14-16 participants at a particular clinic, we will randomize participants to MORE or TAU, and the MORE group will begin. Participants randomized to the MORE condition will participate in eight, weekly, two-hour group sessions led by a clinic or study counselor. Each session will contain 6-8 participants and take place in a private room at the methadone clinic. 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 at baseline, 8- and 16- weeks post-baseline in private rooms in the methadone clinics. Each participant will also have a urine or saliva sample collected during 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, 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 as an Adjunct to Methadone Treatment for Opioid Use and Chronic Pain Management Pilot

Conditions
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Opioid Use, Chronic Pain

Intervention / Treatment
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* Behavioral: Mindfulness Oriented Recovery Enhancement
* Behavioral: Methadone program behavioral treatment as usual


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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. Exclusion Criteria: 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.

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: None (Open Label)


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 program behavioral 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. | Behavioral: Methadone program behavioral 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: Treatment as Usual, TAU;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Days of Illicit Drug Use | Research staff asked participants if they used various drugs (i.e., heroin, cocaine, opioids, marijuana, amphetamines, inhalants, hallucinogens, benzodiazepines, zolpidem, methylphenidate, or other drugs) in the past 30 days and the number of days of use for each drug in the past 30 days. Days of illicit drug use was determined by counting the number of days each participant used drugs based on past-30 day self-reports at the16-week assessments. | 16-weeks | 
| Days of Illicit Opioid Use | Research staff asked participants if they used illicit opioids in the past 30 days and the number of days of use for each drug in the past 30 days. Days of illicit opioid use was determined by counting the number of days each participant used illicit opioids based on past-30 day self-reports at the 16-week assessment. | 16-weeks | 
| Opioid Craving | Research staff assessed opioid craving with a version of the Penn Alcohol Craving Scale (PACS; Flannery et al., 1999) that was adapted to assess craving to opioids at 16-weeks. Scores range from 0 to 36. Higher scores indicate greater craving. | 16-weeks | 
| Pain Level. | Pain was assess with the pain subscale (i.e., bodily pain severity and interference) of the RAND 36-Item Short Form Health Survey. Scores range from 0 to 100, with higher scores indicating better functioning, health, and well-being and less pain, limitations, and symptom severity or interference as compared to lower scores. | 16-weeks | 
| Depression Level. | Depression was measured with Center for Epidemiologic Studies Depression Scale (CES-D). The CES-D scale is a widely used valid and reliable measure that consists of 20 items with potential scores ranging from 0 to 60. A score above 16 on the CES-D indicates clinically significant symptoms of depression. Higher scores on the CES-D indicates greater depression. | 16-weeks | 
| Anxiety Level. | Anxiety was measured with the Beck Anxiety Inventory (BAI). The BAI is also a widely used, reliable, and valid scale that consists of 21 items with potential scores ranging from 0 to 63. A score of 16 or higher indicates clinically sig-nificant symptoms of anxiety. A higher score on the BAI indicates greater anxiety. | 16-weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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opioid, chronic pain, methadone, mindfulness