Yoga for Pain and Opioid Dependence

Chronic Pain Clinical Trial

— Yoga  

Official title:

Yoga for Pain and Opioid Dependence

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01590251
• Other study ID #: 1111009292
• Status: Completed
• Phase: Phase 1/Phase 2
• First received: April 30, 2012
• Last updated: September 23, 2015
• Start date: April 2012
• Est. completion date: November 2014

Study information

• Verified date: September 2015
• Source: Yale University
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 8
• Est. completion date: November 2014
• Est. primary completion date: November 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 65 Years

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Factorial Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Chronic Pain
• Opioid Addiction

Intervention

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.

Locations

Country	Name	City	State
United States	MRU	New Haven	Connecticut

Sponsors (1)

Lead Sponsor	Collaborator
Yale University

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Pain reduction	Pain reduction will be measured by patient self-report using standard pain rating scales.	8 weeks	No
Primary	Reduce illicit opioid use	Reduced illicit opioid use will be measured by patient self-report and urinalysis testing.	8 weeks	No