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

April 30, 2012
June 20, 2014
April 2012
April 2016   (final data collection date for primary outcome measure)
  • 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.
Same as current
Complete list of historical versions of study NCT01590251 on ClinicalTrials.gov Archive Site
Not Provided
Not Provided
Not Provided
Not Provided
 
Yoga for Pain and Opioid Dependence
Yoga for Pain and Opioid Dependence

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

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).
Interventional
Phase 1
Phase 2
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Factorial Assignment
Masking: Open Label
Primary Purpose: Treatment
  • Chronic Pain
  • Opioid Addiction
  • 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.
  • 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
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Active, not recruiting
48
June 2017
April 2016   (final data collection date for primary outcome measure)

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
Both
18 Years to 65 Years
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT01590251
1111009292
No
Yale University
Yale University
Not Provided
Principal Investigator: Declan T Barry, Ph.D. Yale University
Yale University
June 2014

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