Comment Period Extended to 3/23/2015 for Notice of Proposed Rulemaking (NPRM) for FDAAA 801 and NIH Draft Reporting Policy for NIH-Funded Trials
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Yoga for Pain and Opioid Dependence

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Yale University
ClinicalTrials.gov Identifier:
NCT01590251
First received: April 30, 2012
Last updated: June 20, 2014
Last verified: June 2014
History of Changes
  Purpose

This study is designed to develop an effective adjunctive treatment using yoga for chronic pain and opioid dependence.


Condition Intervention Phase
Chronic Pain
Opioid Addiction
 Other: Yoga
Behavioral: Educational Counseling
 Phase 1
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Factorial Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Yoga for Pain and Opioid Dependence

Resource links provided by NLM:

MedlinePlus related topics: Chronic Pain
U.S. FDA Resources

Further study details as provided by Yale University:

Primary Outcome Measures:
  • Pain reduction [ Time Frame: 8 weeks ] [ Designated as safety issue: No ]
    Pain reduction will be measured by patient self-report using standard pain rating scales.

  • Reduce illicit opioid use [ Time Frame: 8 weeks ] [ Designated as safety issue: No ]
    Reduced illicit opioid use will be measured by patient self-report and urinalysis testing.
Estimated Enrollment: 48
Study Start Date: April 2012
Estimated Study Completion Date: June 2017
Estimated Primary Completion Date: April 2016 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Yoga
Gentle yoga for chronic pain and opioid dependence
 Other: Yoga
Two yoga sessions per week for 8 weeks (one yoga session is instructional, the other is a practice session.
Active Comparator: Educational Counseling
Educational counseling is a didactic, lecture-discussion format to supplement the information and advice provided in opioid agonist maintenance treatment.
 Behavioral: Educational Counseling
One didactic session per week of approximately 50 minutes that provides information about chronic pain and substance abuse disorders.

Detailed Description:

This study aims to develop an adjunctive novel treatment intervention using yoga in opioid agonist maintained patients to effectively treat the co-occurring disorders of non-malignant chronic pain and opioid dependence (POD).

Specific Aims:

  1. To conduct a pre-pilot phase with 8 patients with POD receiving opioid agonist maintenance treatment.
  2. To conduct a pilot randomized, clinical trial to obtain data regarding the feasibility, acceptability and efficacy (compared to Educational Counseling [EC]) of manual-guided yoga for POD for patients with POD treated with opioid agonist maintenance (N=40).
  Eligibility
Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • 18 years of age or older
  • Prescription opioid addiction or heroin addiction
  • Moderate to severe chronic pain,
  • Understands English

Exclusion Criteria:

  • Current suicide or homicide risk
  • Life threatening or unstable medical condition
  • Medical or psychiatric condition that is judged to be of clinical concern by the PI or admitting clinician
  • Pregnancy
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01590251

Locations
United States, Connecticut
MRU
New Haven, Connecticut, United States, 06519
Sponsors and Collaborators
Yale University
Investigators
Principal Investigator: Declan T Barry, Ph.D. Yale University
  More Information

No publications provided

Responsible Party: Yale University
ClinicalTrials.gov Identifier: NCT01590251     History of Changes
Other Study ID Numbers: 1111009292
Study First Received: April 30, 2012
Last Updated: June 20, 2014
Health Authority: United States: Institutional Review Board

Keywords provided by Yale University:
Pain
Addiction
Buprenorphine
 Counseling
Methadone
Yoga

ClinicalTrials.gov processed this record on February 27, 2015