Back to resultsYoga for Pain and Opioid Dependence (Yoga)
Primary Purpose
Chronic Pain, Opioid Addiction
Status
Completed
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
Yoga
Educational Counseling
Sponsored by
About this trial
This is an interventional treatment trial for Chronic Pain focused on measuring Pain, Addiction, Buprenorphine, Counseling, Methadone, Yoga
Eligibility 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
Sites / Locations
- MRU
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Yoga
Educational Counseling
Arm Description
Gentle yoga for chronic pain and opioid dependence
Educational counseling is a didactic, lecture-discussion format to supplement the information and advice provided in opioid agonist maintenance treatment.
Outcomes
Primary Outcome Measures
Pain reduction
Pain reduction will be measured by patient self-report using standard pain rating scales.
Reduce illicit opioid use
Reduced illicit opioid use will be measured by patient self-report and urinalysis testing.
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT01590251
Brief Title
Yoga for Pain and Opioid Dependence
Acronym
Yoga
Official Title
Yoga for Pain and Opioid Dependence
Study Type
Interventional
2. Study Status
Record Verification Date
September 2015
Overall Recruitment Status
Completed
Study Start Date
April 2012 (undefined)
Primary Completion Date
November 2014 (Actual)
Study Completion Date
November 2014 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Yale University
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Chronic Pain, Opioid Addiction
Keywords
Pain, Addiction, Buprenorphine, Counseling, Methadone, Yoga
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 1, Phase 2
Interventional Study Model
Factorial Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
8 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Yoga
Arm Type
Experimental
Arm Description
Gentle yoga for chronic pain and opioid dependence
Arm Title
Educational Counseling
Arm Type
Active Comparator
Arm Description
Educational counseling is a didactic, lecture-discussion format to supplement the information and advice provided in opioid agonist maintenance treatment.
Intervention Type
Other
Intervention Name(s)
Yoga
Intervention Description
Two yoga sessions per week for 8 weeks (one yoga session is instructional, the other is a practice session.
Intervention Type
Behavioral
Intervention Name(s)
Educational Counseling
Intervention Description
One didactic session per week of approximately 50 minutes that provides information about chronic pain and substance abuse disorders.
Primary Outcome Measure Information:
Title
Pain reduction
Description
Pain reduction will be measured by patient self-report using standard pain rating scales.
Time Frame
8 weeks
Title
Reduce illicit opioid use
Description
Reduced illicit opioid use will be measured by patient self-report and urinalysis testing.
Time Frame
8 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Declan T Barry, Ph.D.
Organizational Affiliation
Yale University
Official's Role
Principal Investigator
Facility Information:
Facility Name
MRU
City
New Haven
State/Province
Connecticut
ZIP/Postal Code
06519
Country
United States
12. IPD Sharing Statement
Learn more about this trial
Yoga for Pain and Opioid Dependence
We'll reach out to this number within 24 hrs