Yoga for Pain and Opioid Dependence (Yoga)

This study has been completed.

Sponsor:

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

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 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 ]
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.


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)
Sexes Eligible for Study:	All
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


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

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 June 22, 2017

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