Yoga for Pain and Opioid Dependence (Yoga)

September 23, 2015 updated by: Yale University
This study is designed to develop an effective adjunctive treatment using yoga for chronic pain and opioid dependence.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

8

Phase

  • Phase 2
  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Connecticut
      • New Haven, Connecticut, United States, 06519
        • MRU

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 65 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Factorial Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Pain reduction
Time Frame: 8 weeks
Pain reduction will be measured by patient self-report using standard pain rating scales.
8 weeks
Reduce illicit opioid use
Time Frame: 8 weeks
Reduced illicit opioid use will be measured by patient self-report and urinalysis testing.
8 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Yale University

Investigators

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

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

April 1, 2012

Primary Completion (Actual)

November 1, 2014

Study Completion (Actual)

November 1, 2014

Study Registration Dates

First Submitted

April 30, 2012

First Submitted That Met QC Criteria

April 30, 2012

First Posted (Estimate)

May 2, 2012

Study Record Updates

Last Update Posted (Estimate)

September 25, 2015

Last Update Submitted That Met QC Criteria

September 23, 2015

Last Verified

September 1, 2015

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 1111009292

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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