Yoga for Pain and Opioid Dependence

• Sponsor: Yale University (Other)
• Overall Status: Completed
• CT.gov ID: NCT01590251
• Collaborator: (none)
• Enrollment: 8
• Location: 1
• Arms: 2
• Duration (Months): 31
• Patients Per Site Per Month: 0.3

Study Details

Study Description

Brief Summary

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

Condition or Disease	Intervention/Treatment	Phase
Chronic Pain; Opioid Addiction	Other: Yoga; Behavioral: Educational Counseling	Phase 1/Phase 2

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 Design

• Study Type: Interventional
• Actual Enrollment: 8 participants
• Allocation: Randomized
• Intervention Model: Factorial Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: Yoga for Pain and Opioid Dependence
• Study Start Date: Apr 1, 2012
• Actual Primary Completion Date: Nov 1, 2014
• Actual Study Completion Date: Nov 1, 2014

Arms and Interventions

Arm	Intervention/Treatment
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.

Outcome Measures

Primary Outcome Measures

1. Pain reduction [8 weeks]

   Pain reduction will be measured by patient self-report using standard pain rating scales.

2. Reduce illicit opioid use [8 weeks]

   Reduced illicit opioid use will be measured by patient self-report and urinalysis testing.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 65 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Locations

	Site	City	State	Country	Postal Code
1	MRU	New Haven	Connecticut	United States	06519

Sponsors and Collaborators

• Yale University

Investigators

• Principal Investigator: Declan T Barry, Ph.D., Yale University

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Yale University
• ClinicalTrials.gov Identifier: NCT01590251
• Other Study ID Numbers: 1111009292
• First Posted: May 2, 2012
• Last Update Posted: Sep 25, 2015
• Last Verified: Sep 1, 2015

• Keywords provided by Yale University: Pain; Addiction; Buprenorphine; Counseling; Methadone; Yoga
• Additional relevant MeSH terms: Chronic Pain; Opioid-Related Disorders; Behavior, Addictive

Study Results

No Results Posted as of Sep 25, 2015