The Heroes Circle Opioid Project
Condition: Opioid-use Disorder
MeSH terms: Opioid-Related Disorders
Study type: Observational

Summary: 
      The purpose of this proposed pilot study is to extend the KKC Heroes Circle program to people
      with opioid use disorder (OUD) who are currently enrolled in methadone maintenance treatment
      (MMT) and who wish to learn these techniques to reduce their behavioral and physiological
      dependence on medication.

      The goal is to engage these MMT patients in a complementary (non-pharmacological) therapeutic
      activity that may improve their self-efficacy and personal control, reduce the impact of
      stressors and chronic pain, drug craving, affective and physical function, and lower reliance
      on pharmacological interventions.
    

Detailed description: 
      Overall, this project will take approximately 1 year to complete, and will be divided into
      three phases (each about three months long).

      Phase 1: The investigators will identify and consent 10 patients, regardless of age, sex, or
      race/ethnicity, enrolled at the Tolan Park Research Clinic who endorse a desire to lower
      their daily methadone maintenance dose but have been unable to do so.

      Each participant will complete a 12-week protocol. There will be twice weekly visits (each
      ≈30 min total for all procedures) by the trained adult Kids Kicking Cancer (KKC) martial
      artists. Prior to receiving his/her methadone dose, the martial artist and patient will meet
      in a private area to promote attention and focus on the intervention, and for measurement of
      biomarker data. At baseline and during weeks 4, 8 and 12, the investigators will obtain pre-
      and post-session saliva samples (collected with a Salivette held under the tongue 3 min) to
      measure two stress biomarkers. The investigators will also measure heart rate and blood
      pressure. Each participant will receive 20 minutes of individual instruction in a therapeutic
      approach to lower their stress and life challenges. Each visit will include certain martial
      arts rituals, including the KKC "Power, Peace, Purpose"™ mantra, and Breath Brake®,
      introduced by videotapes made by the "heroes" (children). Other components of the
      intervention session, e.g. movement exercises and mental imagery, will be tailored to the
      patient, always ensuring that any physical maneuver is safe for that individual. They will
      also receive audio meditations for smart phones or, if unavailable, loaded onto mp3 players
      to practice the meditations.

      At the beginning and end of each visit by the martial artist, the participant will use Visual
      Analog Scales (VAS, 0-10 range) to rate his/her momentary level of "pain", "drug craving",
      "anxiety", "anger", and "depression"; and he/she will complete the short form of the Positive
      and Negative Affect Schedule. Each meeting will be supplemented by phone calls 3 times a week
      from the martial artist to each patient to supply support.

      Data collection measurements: Beck Depression Inventory-II, State-Trait Anxiety Inventory,
      Perceived Stress Scale, Difficulties with Emotion Regulation Scale, Coping Orientation to
      Problems Experienced (Brief-COPE), Alcohol and Drug Use Self-Efficacy Scale, Distress
      Tolerance Scale, Breath-hold Endurance task, Brief Pain Inventory, Medical Outcomes Study
      Short Form, a computerized measure of attentional function, the Attentional Network Task,
      also known as Flanker Task.

      Methadone dose (baseline and weekly) and urine drug test results (baseline and twice weekly
      for these study participants) will be extracted from the patient's medical record, with the
      assistance of an authorized staff member.

      Each Phase I participant will undergo non-Virtual Reality (VR) intervention procedures during
      weeks 1-6, and will then undergo VR-based intervention during weeks 7-12.

      Phase 2 will extend phase 1 by evaluating a second group of 10 patients who will also
      participate over a 12-week period. Identical procedures to Phase 1 will be used; in addition,
      the investigators will include whole-brain fMRI (functional magnetic resonance imaging)
      scanning before and after completion of the full intervention. Patients will use a Virtual
      Reality (VR) program that enables the patient to choose his/her obstacles and "see" that
      obstacle inside his/her head.

      Phase 3 will enroll 10 additional patients (different participants from phases 1 and 2) who
      use opioids while complaining of specific chronic pain syndrome. In this phase, the same
      protocol will be used, including fMRI scanning. The Virtual Reality, however, will focus
      specifically on creating the image of the pain in wherever the pain is being reported in the
      body.
    

Intervention name(s): Kids Kicking Cancer program
Intervention type(s): Behavioral
Intervention description(s): Individual instruction on how to lower stress and life challenges. Patient and martial artist will work together to identify obstacles that interfere with methadone goal reduction. Training will include learning certain martial arts rituals and breathing techniques. Patients will receive audio meditations for smart phone devices and regular reminders to practice. Each weekly meeting will be supplemented by 3 phone calls per week from the martial artist to support the training. Additionally a virtual reality device will be used to help lower stress.
Observational model: Cohort
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        People with opioid use disorder (OUD), currently enrolled in methadone maintenance
        treatment (MMT) who wish to learn techniques to reduce their behavioral and physiological
        dependence on medication.