<clinical_study>
  <!-- This xml conforms to an XML Schema at:
    https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
  <required_header>
    <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
    <link_text>Link to the current ClinicalTrials.gov record.</link_text>
    <url>https://clinicaltrials.gov/ct2/show/NCT03022890</url>
  </required_header>
  <id_info>
    <org_study_id>R34AT009432</org_study_id>
    <secondary_id>R34AT009432</secondary_id>
    <nct_id>NCT03022890</nct_id>
  </id_info>
  <brief_title>Study of Yoga vs. Health Education for Chronic Pain in Persons Receiving Opioid Agonist Therapy</brief_title>
  <official_title>Pilot Study of Yoga vs. Health Education for Chronic Pain in Persons Receiving Opioid Agonist Therapy</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Butler Hospital</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>National Center for Complementary and Integrative Health (NCCIH)</agency>
      <agency_class>NIH</agency_class>
    </collaborator>
  </sponsors>
  <source>Butler Hospital</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      The Specific Aims of this treatment development research are:&#xD;
&#xD;
      To conduct a pilot randomized clinical trial (n = 40) of hatha yoga vs. a health education&#xD;
      group (attention control) for persons with chronic pain who are taking methadone maintenance&#xD;
      therapy (MMT) or bupreonorphine (BUP) for opioid use disorder maintenance treatment.&#xD;
      Participants will be enrolled in the active intervention for 3 months, and then be followed&#xD;
      for 6 months afterwards. Investigators' aims are:&#xD;
&#xD;
        1. To assess feasibility and acceptability of both the yoga class and the health education&#xD;
           control group. Investigators will assess credibility of the assigned intervention and&#xD;
           expectancy for improvement for both groups at baseline, program satisfaction following&#xD;
           program participation, participant adherence (class attendance rate and amount of home&#xD;
           practice corresponding to assigned study arm), and instructor fidelity to the manuals.&#xD;
           Investigators will conduct structured interviews following program participation to&#xD;
           understand specific aspects of both programs considered attractive, useful, or not&#xD;
           useful; we will solicit suggestions for improvements as well.&#xD;
&#xD;
        2. To assess safety, investigators will track all adverse events in a structured fashion.&#xD;
           Investigators do not expect to see any serious adverse events definitely or probably&#xD;
           related to study participation.&#xD;
&#xD;
        3. To assess feasibility of research procedures, investigators have benchmarks for&#xD;
           recruitment rate, retention for study assessments, and reliability of instructor&#xD;
           fidelity measures.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Chronic pain is a significant problem for people receiving opioid agonist therapy (OAT) for&#xD;
      opioid dependence - i.e., buprenorphine/ naloxone (BUP) and methadone maintenance treatment&#xD;
      (MMT). At least half of patients receiving BUP and MMT report chronic pain. In this&#xD;
      population, chronic pain is associated with pain-related disability, psychiatric problems,&#xD;
      physical problems, and increased likelihood of misuse of opioids or other illicit drugs,&#xD;
      often leading providers to terminate treatment. Several issues complicate pharmacologic pain&#xD;
      treatment in OAT patients, including opioid-induced hyperalgesia, increased tolerance of&#xD;
      opioids, illicit drug use, use of benzodiazepines and alcohol, and patients' own fears about&#xD;
      medications and addiction. Further, providers may have insufficient education regarding pain&#xD;
      management in OAT patients, and have difficulty resolving the seeming inconsistencies between&#xD;
      a pain management approach and an addiction management approach. There are few studies of&#xD;
      non-pharmacologic treatment approaches to pain in OAT patients. Cognitive-behavioral therapy&#xD;
      may be efficacious for treating pain across a range of chronic pain conditions, but studies&#xD;
      of CBT for pain relief amongst substance abusers are rare.&#xD;
&#xD;
      Hatha yoga may be a beneficial adjunctive approach to treating chronic pain, decreasing&#xD;
      pain-related disability, and preventing opioid misuse during OAT. Hatha yoga involves breath&#xD;
      control (pranayama), physical postures (asanas), and meditation (dhyana). Yoga includes&#xD;
      benefits of relaxation training, physical activity, and mindfulness training in a single&#xD;
      unified practice. Further, yoga is a non-pharmacologic approach to pain, and therefore avoids&#xD;
      many of the problems surrounding pharmacologic treatment of chronic pain in people receiving&#xD;
      OAT. Yoga is a promising approach for treatment of chronic pain in people enrolled in OAT&#xD;
      because: 1) yoga has evidence supporting its ability to reduce pain-related disability and&#xD;
      pain severity in other populations; 2) there are plausible cognitive/affective and behavioral&#xD;
      mechanisms by which yoga may reduce chronic pain, decrease pain-related disability, and&#xD;
      reduce opioid misuse; 3) yoga is increasingly popular and available; 4) yoga can be a&#xD;
      complement to other types of pain and substance use treatment; 5) yoga students may like the&#xD;
      focus on improving overall health and well-being rather than on &quot;fixing&quot; a problem.&#xD;
&#xD;
      Thus, the investigators propose to conduct treatment development research that would prepare&#xD;
      us to study whether yoga (vs. a health education control group) might be an efficacious&#xD;
      adjunctive treatment for pain in people enrolled in OAT for opioid use disorders.&#xD;
&#xD;
      The specific aims are:&#xD;
&#xD;
      To conduct a pilot randomized clinical trial (n = 40) of hatha yoga vs. a health education&#xD;
      group (attention control) for persons with chronic pain who are taking methadone maintenance&#xD;
      therapy (MMT) or bupreonorphine (BUP) for opioid use disorder maintenance treatment.&#xD;
      Participants will be enrolled in the active intervention for 3 months, and then be followed&#xD;
      for 6 months afterwards. Investigators' aims are:&#xD;
&#xD;
        1. To assess feasibility and acceptability of both the yoga class and the health education&#xD;
           control group. Investigators will assess credibility of the assigned intervention and&#xD;
           expectancy for improvement for both groups at baseline, program satisfaction following&#xD;
           program participation, participant adherence (class attendance rate and amount of home&#xD;
           practice corresponding to assigned study arm), and instructor fidelity to the manuals.&#xD;
           Investigators will conduct structured interviews following program participation to&#xD;
           understand specific aspects of both programs considered attractive, useful, or not&#xD;
           useful; we will solicit suggestions for improvements as well.&#xD;
&#xD;
        2. To assess safety, investigators will track all adverse events in a structured fashion.&#xD;
           Investigators do not expect to see any serious adverse events definitely or probably&#xD;
           related to study participation.&#xD;
&#xD;
        3. To assess feasibility of research procedures, investigators have benchmarks for&#xD;
           recruitment rate, retention for study assessments, and reliability of instructor&#xD;
           fidelity measures.&#xD;
&#xD;
      Investigators will use information collected from participant interviews as well as feedback&#xD;
      from yoga and health education instructors and experts in addiction, chronic pain, and yoga&#xD;
      to make modifications to interventions or research procedures intended to improve&#xD;
      acceptability, feasibility, and safety whenever possible. This project will provide&#xD;
      investigators with materials, experience, and pilot data needed for the next stage of this&#xD;
      line of research, namely, a fully powered randomized clinical trial. Hatha yoga has a&#xD;
      potential to decrease pain-related disability, pain severity, and opioid misuse in this&#xD;
      population of people with difficult-to-treat chronic pain.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">April 1, 2017</start_date>
  <completion_date type="Actual">July 1, 2019</completion_date>
  <primary_completion_date type="Actual">November 16, 2018</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Client Satisfaction Questionnaire</measure>
    <time_frame>3 months</time_frame>
    <description>satisfaction with interventions</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Credibility Expectancy Questionnaire (CEQ)</measure>
    <time_frame>1 month</time_frame>
    <description>credibility of interventions and expectancy of improvement due to interventions</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Participant adherence</measure>
    <time_frame>3 months</time_frame>
    <description>Class attendance</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Participant homework adherence</measure>
    <time_frame>3 months</time_frame>
    <description>Homework questionnaire</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Instructor manual fidelity checklist</measure>
    <time_frame>3 months</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>Systematic Assessment of Treatment-Emergent Events - General Inquiry</measure>
    <time_frame>3 months</time_frame>
    <description>used for documenting any adverse events</description>
  </primary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">40</enrollment>
  <condition>Opioid-Related Disorders</condition>
  <condition>Pain, Chronic</condition>
  <arm_group>
    <arm_group_label>Hatha yoga</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>12 weeks of hatha yoga classes, once per week</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Health education</arm_group_label>
    <arm_group_type>Placebo Comparator</arm_group_type>
    <description>12 weeks of health education classes, once per week</description>
  </arm_group>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>hatha yoga</intervention_name>
    <description>12 weeks of hour-long gentle hatha yoga classes</description>
    <arm_group_label>Hatha yoga</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>health education</intervention_name>
    <description>12 weeks of hour-long classes on nutrition, sleep, coping with pain, and other health educaiton topics</description>
    <arm_group_label>Health education</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          1. Enrolled in methadone maintenance treatment or buprenorphine treatment for 3 or more&#xD;
             months;&#xD;
&#xD;
          2. Plan to continue this treatment for next 6 months;&#xD;
&#xD;
          3. Chronic pain, defined as pain duration for at least three months (Dworkin et al.,&#xD;
             2012), a mean score of 4 or higher on the BPI Pain Interference Scale (C. S. Cleeland&#xD;
             &amp; Ryan, 1994), and pain severity of 4 or higher on a Visual Analog Scale (0-10)&#xD;
             indicating &quot;worst pain in the last week&quot;(Breivik et al., 2008; Jensen, Chen, &amp;&#xD;
             Brugger, 2003);&#xD;
&#xD;
          4. No current psychosis;&#xD;
&#xD;
          5. Do not anticipate have surgery in the next 6 months;&#xD;
&#xD;
          6. Not currently taking yoga classes, not practicing yoga once per week or more often at&#xD;
             home;&#xD;
&#xD;
          7. Not engaging in meditation once per week or more often;&#xD;
&#xD;
          8. Medically cleared by a primary care physician or SSTAR's OAT physician for&#xD;
             mild-moderate physical activity (this is the only criterion NOT required for Phase 1&#xD;
             participants);&#xD;
&#xD;
          9. Not pregnant;&#xD;
&#xD;
         10. Aged 18 or older;&#xD;
&#xD;
         11. Proficiency in English sufficient to engage in informed consent in English and&#xD;
             understand classes taught in English.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
        -&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>Stanley Street Treatment and Resources</name>
      <address>
        <city>Fall River</city>
        <state>Massachusetts</state>
        <zip>02720</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>August 2019</verification_date>
  <study_first_submitted>January 5, 2017</study_first_submitted>
  <study_first_submitted_qc>January 13, 2017</study_first_submitted_qc>
  <study_first_posted type="Estimate">January 18, 2017</study_first_posted>
  <last_update_submitted>August 8, 2019</last_update_submitted>
  <last_update_submitted_qc>August 8, 2019</last_update_submitted_qc>
  <last_update_posted type="Actual">August 9, 2019</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Chronic Pain</mesh_term>
    <mesh_term>Opioid-Related Disorders</mesh_term>
  </condition_browse>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT03022890
org study id: R34AT009432
secondary id: R34AT009432
nct id: NCT03022890
lead sponsor: 
collaborator: 
has dmc: Yes
is fda regulated drug: No
is fda regulated device: No
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.
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.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Client Satisfaction Questionnaire
time frame: 3 months
description: satisfaction with interventions
measure: Credibility Expectancy Questionnaire (CEQ)
time frame: 1 month
description: credibility of interventions and expectancy of improvement due to interventions
measure: Participant adherence
time frame: 3 months
description: Class attendance
measure: Participant homework adherence
time frame: 3 months
description: Homework questionnaire
measure: Instructor manual fidelity checklist
time frame: 3 months
measure: Systematic Assessment of Treatment-Emergent Events - General Inquiry
time frame: 3 months
description: used for documenting any adverse events
arm group label: Hatha yoga
arm group type: Experimental
description: 12 weeks of hatha yoga classes, once per week
arm group label: Health education
arm group type: Placebo Comparator
description: 12 weeks of health education classes, once per week
intervention type: Behavioral
intervention name: hatha yoga
description: 12 weeks of hour-long gentle hatha yoga classes
arm group label: Hatha yoga
intervention type: Behavioral
intervention name: health education
description: 12 weeks of hour-long classes on nutrition, sleep, coping with pain, and other health educaiton topics
arm group label: Health education
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
facility: 
country: United States
responsible party type: Sponsor
mesh term: Chronic Pain
mesh term: Opioid-Related Disorders