Yoga for Pain and Opioid Dependence (Yoga)
This study has been completed.
Sponsor:
Yale University
Information provided by (Responsible Party):
Yale University
ClinicalTrials.gov Identifier:
NCT01590251
First received: April 30, 2012
Last updated: September 23, 2015
Last verified: September 2015
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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:
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.
| Enrollment: | 8 |
| Study Start Date: | April 2012 |
| Study Completion Date: | November 2014 |
| Primary Completion Date: | November 2014 (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.
Eligibility| Ages Eligible for Study: | 18 Years to 65 Years (Adult) |
| 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
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
| Responsible Party: | Yale University |
| ClinicalTrials.gov Identifier: | NCT01590251 History of Changes |
| Other Study ID Numbers: | 1111009292 |
| Study First Received: | April 30, 2012 |
| Last Updated: | September 23, 2015 |
| Health Authority: | United States: Institutional Review Board |
Keywords provided by Yale University:
|
Pain Addiction Buprenorphine |
Counseling Methadone Yoga |
Additional relevant MeSH terms:
|
Chronic Pain Behavior, Addictive Pain Neurologic Manifestations Nervous System Diseases Signs and Symptoms Compulsive Behavior Impulsive Behavior |
Analgesics, Opioid Narcotics Central Nervous System Depressants Physiological Effects of Drugs Analgesics Sensory System Agents Peripheral Nervous System Agents |
ClinicalTrials.gov processed this record on September 23, 2016