Yoga for Pain and Opioid Dependence

NCT ID: NCT01590251

Last Updated: 2015-09-25

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1/PHASE2

Total Enrollment

8 participants

Study Classification

INTERVENTIONAL

Study Start Date

2012-04-30

Study Completion Date

2014-11-30

Brief Summary

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

Detailed Description

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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.

Conditions

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Chronic Pain Opioid Addiction

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

FACTORIAL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Yoga

Gentle yoga for chronic pain and opioid dependence

Group Type EXPERIMENTAL

Yoga

Intervention Type OTHER

Two yoga sessions per week for 8 weeks (one yoga session is instructional, the other is a practice session.

Educational Counseling

Educational counseling is a didactic, lecture-discussion format to supplement the information and advice provided in opioid agonist maintenance treatment.

Group Type ACTIVE_COMPARATOR

Educational Counseling

Intervention Type BEHAVIORAL

One didactic session per week of approximately 50 minutes that provides information about chronic pain and substance abuse disorders.

Interventions

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Yoga

Two yoga sessions per week for 8 weeks (one yoga session is instructional, the other is a practice session.

Intervention Type OTHER

Educational Counseling

One didactic session per week of approximately 50 minutes that provides information about chronic pain and substance abuse disorders.

Intervention Type BEHAVIORAL

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Yale University

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Declan T Barry, Ph.D.

Role: PRINCIPAL_INVESTIGATOR

Yale University

Locations

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MRU

New Haven, Connecticut, United States

Site Status

Countries

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United States

Other Identifiers

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1111009292

Identifier Type: -

Identifier Source: org_study_id

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