The Heroes Circle Opioid Project

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.

Inclusion Criteria:

1. Current diagnosis of Opioid Use Disorder

2. Stable daily methadone dose for at least one month prior to enrollment

3. Desire to reduce the daily methadone dose at least 20%.

Exclusion Criteria:

1. Pregnant (urine test) or lactating (self-report)

2. Current severe Axis I psychiatric disorder, e.g. psychosis, bipolar disorder

3. Suicidal ideation/attempt during the past year

4. Medical contraindications to the proposed therapeutic program, in the opinion of the
clinic physician.