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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT01590251
Other study ID # 1111009292
Secondary ID
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


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
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