Study of Yoga vs. Health Education for Chronic Pain in Persons Receiving Opioid Agonist Therapy

Chronic pain is a significant problem for people receiving opioid agonist therapy (OAT) for
opioid dependence - i.e., buprenorphine/ naloxone (BUP) and methadone maintenance treatment
(MMT). At least half of patients receiving BUP and MMT report chronic pain. In this
population, chronic pain is associated with pain-related disability, psychiatric problems,
physical problems, and increased likelihood of misuse of opioids or other illicit drugs,
often leading providers to terminate treatment. Several issues complicate pharmacologic pain
treatment in OAT patients, including opioid-induced hyperalgesia, increased tolerance of
opioids, illicit drug use, use of benzodiazepines and alcohol, and patients' own fears about
medications and addiction. Further, providers may have insufficient education regarding pain
management in OAT patients, and have difficulty resolving the seeming inconsistencies between
a pain management approach and an addiction management approach. There are few studies of
non-pharmacologic treatment approaches to pain in OAT patients. Cognitive-behavioral therapy
may be efficacious for treating pain across a range of chronic pain conditions, but studies
of CBT for pain relief amongst substance abusers are rare.

Hatha yoga may be a beneficial adjunctive approach to treating chronic pain, decreasing
pain-related disability, and preventing opioid misuse during OAT. Hatha yoga involves breath
control (pranayama), physical postures (asanas), and meditation (dhyana). Yoga includes
benefits of relaxation training, physical activity, and mindfulness training in a single
unified practice. Further, yoga is a non-pharmacologic approach to pain, and therefore avoids
many of the problems surrounding pharmacologic treatment of chronic pain in people receiving
OAT. Yoga is a promising approach for treatment of chronic pain in people enrolled in OAT
because: 1) yoga has evidence supporting its ability to reduce pain-related disability and
pain severity in other populations; 2) there are plausible cognitive/affective and behavioral
mechanisms by which yoga may reduce chronic pain, decrease pain-related disability, and
reduce opioid misuse; 3) yoga is increasingly popular and available; 4) yoga can be a
complement to other types of pain and substance use treatment; 5) yoga students may like the
focus on improving overall health and well-being rather than on "fixing" a problem.

Thus, the investigators propose to conduct treatment development research that would prepare
us to study whether yoga (vs. a health education control group) might be an efficacious
adjunctive treatment for pain in people enrolled in OAT for opioid use disorders.

The specific aims are:

To conduct a pilot randomized clinical trial (n = 40) of hatha yoga vs. a health education
group (attention control) for persons with chronic pain who are taking methadone maintenance
therapy (MMT) or bupreonorphine (BUP) for opioid use disorder maintenance treatment.
Participants will be enrolled in the active intervention for 3 months, and then be followed
for 6 months afterwards. Investigators' aims are:

1. To assess feasibility and acceptability of both the yoga class and the health education
control group. Investigators will assess credibility of the assigned intervention and
expectancy for improvement for both groups at baseline, program satisfaction following
program participation, participant adherence (class attendance rate and amount of home
practice corresponding to assigned study arm), and instructor fidelity to the manuals.
Investigators will conduct structured interviews following program participation to
understand specific aspects of both programs considered attractive, useful, or not
useful; we will solicit suggestions for improvements as well.

2. To assess safety, investigators will track all adverse events in a structured fashion.
Investigators do not expect to see any serious adverse events definitely or probably
related to study participation.

3. To assess feasibility of research procedures, investigators have benchmarks for
recruitment rate, retention for study assessments, and reliability of instructor
fidelity measures.

Investigators will use information collected from participant interviews as well as feedback
from yoga and health education instructors and experts in addiction, chronic pain, and yoga
to make modifications to interventions or research procedures intended to improve
acceptability, feasibility, and safety whenever possible. This project will provide
investigators with materials, experience, and pilot data needed for the next stage of this
line of research, namely, a fully powered randomized clinical trial. Hatha yoga has a
potential to decrease pain-related disability, pain severity, and opioid misuse in this
population of people with difficult-to-treat chronic pain.

Inclusion Criteria:

1. Enrolled in methadone maintenance treatment or buprenorphine treatment for 3 or more
months;

2. Plan to continue this treatment for next 6 months;

3. Chronic pain, defined as pain duration for at least three months (Dworkin et al.,
2012), a mean score of 4 or higher on the BPI Pain Interference Scale (C. S. Cleeland
& Ryan, 1994), and pain severity of 4 or higher on a Visual Analog Scale (0-10)
indicating "worst pain in the last week"(Breivik et al., 2008; Jensen, Chen, &
Brugger, 2003);

4. No current psychosis;

5. Do not anticipate have surgery in the next 6 months;

6. Not currently taking yoga classes, not practicing yoga once per week or more often at
home;

7. Not engaging in meditation once per week or more often;

8. Medically cleared by a primary care physician or SSTAR's OAT physician for
mild-moderate physical activity (this is the only criterion NOT required for Phase 1
participants);

9. Not pregnant;

10. Aged 18 or older;

11. Proficiency in English sufficient to engage in informed consent in English and
understand classes taught in English.

Exclusion Criteria: