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Yoga for Pain and Opioid Dependence (Yoga)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01590251
Recruitment Status : Completed
First Posted : May 2, 2012
Last Update Posted : September 25, 2015
Sponsor:
Information provided by (Responsible Party):
Yale University

Tracking Information
First Submitted Date  ICMJE April 30, 2012
First Posted Date  ICMJE May 2, 2012
Last Update Posted Date September 25, 2015
Study Start Date  ICMJE April 2012
Actual Primary Completion Date November 2014   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: April 30, 2012)
  • Pain reduction [ Time Frame: 8 weeks ]
    Pain reduction will be measured by patient self-report using standard pain rating scales.
  • Reduce illicit opioid use [ Time Frame: 8 weeks ]
    Reduced illicit opioid use will be measured by patient self-report and urinalysis testing.
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT01590251 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Yoga for Pain and Opioid Dependence
Official Title  ICMJE Yoga for Pain and Opioid Dependence
Brief Summary This study is designed to develop an effective adjunctive treatment using yoga for chronic pain and opioid dependence.
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.

Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 1
Phase 2
Study Design  ICMJE Allocation: Randomized
Intervention Model: Factorial Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE
  • Chronic Pain
  • Opioid Addiction
Intervention  ICMJE
  • Other: Yoga
    Two yoga sessions per week for 8 weeks (one yoga session is instructional, the other is a practice session.
  • Behavioral: Educational Counseling
    One didactic session per week of approximately 50 minutes that provides information about chronic pain and substance abuse disorders.
Study Arms  ICMJE
  • Experimental: Yoga
    Gentle yoga for chronic pain and opioid dependence
    Intervention: Other: Yoga
  • Active Comparator: Educational Counseling
    Educational counseling is a didactic, lecture-discussion format to supplement the information and advice provided in opioid agonist maintenance treatment.
    Intervention: Behavioral: Educational Counseling
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: September 23, 2015)
8
Original Estimated Enrollment  ICMJE
 (submitted: April 30, 2012)
48
Actual Study Completion Date  ICMJE November 2014
Actual Primary Completion Date November 2014   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 65 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01590251
Other Study ID Numbers  ICMJE 1111009292
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Yale University
Study Sponsor  ICMJE Yale University
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Declan T Barry, Ph.D. Yale University
PRS Account Yale University
Verification Date September 2015

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP