Clinical trial NCT03894501: Pilot of Mindfulness Oriented Recovery Enhancement in MethadoneTreatment
Official title: Mindfulness Oriented Recovery Enhancement as an Adjunct to Methadone Treatment for Opioid Use and Chronic Pain Management Pilot
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Opioid Use
Chronic Pain
Keywords: opioid
chronic pain
methadone
mindfulness
Lead sponsor: Rutgers, The State University of New Jersey
Sponsor class: OTHER
Collaborators: name: University of Utah
First posted: 2019-03-28
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Two-arm randomized controlled trial.
Primary purpose: TREATMENT

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).

Detailed description: 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.

Eligibility criteria: 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.

Primary outcomes:
measure: Study Interest
timeFrame: Baseline
measure: Study Refusal
timeFrame: Baseline
measure: Individuals Screened
timeFrame: Baseline (study enrollment)
measure: Individuals Consented.
timeFrame: Baseline (study enrollment)
measure: Refusal After/During Consent Process.
timeFrame: Enrollment
measure: Mean Sessions Completed
timeFrame: At 8-weeks (post treatment period completion).
measure: Percentage of Sessions Completed
timeFrame: At 8-weeks (post treatment period completion).
measure: Number Who Drop Out
timeFrame: At 16 weeks.
measure: Percentage Who Drop Out
timeFrame: At 16 weeks.
measure: Baselines Completed
timeFrame: At baseline,
measure: Percentage Baselines Completed
timeFrame: At baseline,
measure: 8-weeks Completed
timeFrame: At 8-weeks.
measure: Percentage 8-Weeks Completed
timeFrame: At 8-weeks.
measure: 16-Weeks Completed
timeFrame: At 16-weeks.
measure: Percentage of 16-Weeks Completed
timeFrame: At 16-weeks.
Secondary outcomes:
measure: Days of Illicit Drug Use
timeFrame: 16-weeks
measure: Days of Illicit Opioid Use
timeFrame: 16-weeks
measure: Opioid Craving
timeFrame: 16-weeks
measure: Pain Level.
timeFrame: 16-weeks
measure: Depression Level.
timeFrame: 16-weeks
measure: Anxiety Level.
timeFrame: 16-weeks
Other outcomes:
Locations:
city: New Brunswick
country: United States
facility: Rutgers Robert Wood Johnson Medical School
state: New Jersey
Study officials:
affiliation: Rutgers Robert Wood Johnson Medical School
name: Nina A Cooperman, PsyD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.