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| ID | Type | Description | Link |
|---|---|---|---|
| R34AT009432 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| National Center for Complementary and Integrative Health (NCCIH) | NIH |
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The Specific Aims of this treatment development research 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:
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:
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Hatha yoga | Experimental | 12 weeks of hatha yoga classes, once per week |
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| Health education | Placebo Comparator | 12 weeks of health education classes, once per week |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| hatha yoga | Behavioral | 12 weeks of hour-long gentle hatha yoga classes |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Client Satisfaction Questionnaire | satisfaction with interventions | 3 months |
| Credibility Expectancy Questionnaire (CEQ) | credibility of interventions and expectancy of improvement due to interventions | 1 month |
| Participant adherence | Class attendance | 3 months |
| Participant homework adherence | Homework questionnaire | 3 months |
| Instructor manual fidelity checklist | 3 months | |
| Systematic Assessment of Treatment-Emergent Events - General Inquiry | used for documenting any adverse events | 3 months |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Stanley Street Treatment and Resources | Fall River | Massachusetts | 02720 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 31443887 | Derived | Uebelacker LA, Van Noppen D, Tremont G, Bailey G, Abrantes A, Stein M. A pilot study assessing acceptability and feasibility of hatha yoga for chronic pain in people receiving opioid agonist therapy for opioid use disorder. J Subst Abuse Treat. 2019 Oct;105:19-27. doi: 10.1016/j.jsat.2019.07.015. Epub 2019 Jul 24. |
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| ID | Term |
|---|---|
| D009293 | Opioid-Related Disorders |
| D059350 | Chronic Pain |
| ID | Term |
|---|---|
| D000079524 | Narcotic-Related Disorders |
| D019966 | Substance-Related Disorders |
| D064419 | Chemically-Induced Disorders |
| D001523 | Mental Disorders |
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| health education |
| Behavioral |
12 weeks of hour-long classes on nutrition, sleep, coping with pain, and other health educaiton topics |
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| D010146 | Pain |
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |