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

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ClinicalTrials.gov Identifier: NCT03022890
Recruitment Status : Recruiting
First Posted : January 18, 2017
Last Update Posted : October 2, 2018
Sponsor:
Collaborator:
National Center for Complementary and Integrative Health (NCCIH)
Information provided by (Responsible Party):
Butler Hospital

Brief Summary:

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:

  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.

Condition or disease Intervention/treatment Phase
Opioid-Related Disorders Pain, Chronic Behavioral: hatha yoga Behavioral: health education Not Applicable

  Show Detailed Description

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 40 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Pilot Study of Yoga vs. Health Education for Chronic Pain in Persons Receiving Opioid Agonist Therapy
Actual Study Start Date : April 1, 2017
Estimated Primary Completion Date : December 2018
Estimated Study Completion Date : July 2019

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Chronic Pain

Arm Intervention/treatment
Experimental: Hatha yoga
12 weeks of hatha yoga classes, once per week
Behavioral: hatha yoga
12 weeks of hour-long gentle hatha yoga classes

Placebo Comparator: Health education
12 weeks of health education classes, once per week
Behavioral: health education
12 weeks of hour-long classes on nutrition, sleep, coping with pain, and other health educaiton topics




Primary Outcome Measures :
  1. Client Satisfaction Questionnaire [ Time Frame: 3 months ]
    satisfaction with interventions

  2. Credibility Expectancy Questionnaire (CEQ) [ Time Frame: 1 month ]
    credibility of interventions and expectancy of improvement due to interventions

  3. Participant adherence [ Time Frame: 3 months ]
    Class attendance

  4. Participant homework adherence [ Time Frame: 3 months ]
    Homework questionnaire

  5. Instructor manual fidelity checklist [ Time Frame: 3 months ]
  6. Systematic Assessment of Treatment-Emergent Events - General Inquiry [ Time Frame: 3 months ]
    used for documenting any adverse events



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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:


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03022890


Contacts
Contact: Donnell Van Noppen, BA 401-430-0034 dvannoppen@butler.org

Locations
United States, Massachusetts
Stanley Street Treatment and Resources Recruiting
Fall River, Massachusetts, United States, 02720
Contact: Nell Van Noppen, BA         
Contact: Genie Bailey, MD         
Sponsors and Collaborators
Butler Hospital
National Center for Complementary and Integrative Health (NCCIH)

Responsible Party: Butler Hospital
ClinicalTrials.gov Identifier: NCT03022890     History of Changes
Other Study ID Numbers: R34AT009432 ( U.S. NIH Grant/Contract )
R34AT009432 ( U.S. NIH Grant/Contract )
First Posted: January 18, 2017    Key Record Dates
Last Update Posted: October 2, 2018
Last Verified: October 2018

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
Chronic Pain
Opioid-Related Disorders
Pain
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms
Substance-Related Disorders
Chemically-Induced Disorders
Mental Disorders