Pilot of Mindfulness Oriented Recovery Enhancement in MethadoneTreatment

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.

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.