Comment Period Extended to 3/23/2015 for Notice of Proposed Rulemaking (NPRM) for FDAAA 801 and NIH Draft Reporting Policy for NIH-Funded Trials

A Study of Genetic Variation Influencing Pain and Response to Opioid Medications in Patients With Chronic Pain

This study is enrolling participants by invitation only.
Information provided by (Responsible Party):
Larry Fu-nien Chu, Stanford University Identifier:
First received: February 9, 2011
Last updated: February 13, 2012
Last verified: February 2012

The investigators will be collecting saliva DNA samples from chronic back pain patients. The investigators hope to find candidate genes associated with response to opioid medication by correlating molecular genetics data with pain measurement and opioid responsiveness data including opioid hyperalgesia and opioid analgesic tolerance.


Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: A Study of Genetic Variation Influencing Pain and Response to Opioid Medications in Patients With Chronic Pain

Resource links provided by NLM:

Further study details as provided by Stanford University:

Primary Outcome Measures:
  • Genetic association with various physiologic responses to opioid medication in patients [ Time Frame: Up to 5 years ] [ Designated as safety issue: No ]

Biospecimen Retention:   Samples With DNA

Saliva biospecimen collection will be performed via mail or in person. The Principal Investigator will send participants a letter informing them of the opportunity to participate in a study of genetic variation influencing pain and opioid responsiveness phenotypes. If participants agree to provide a saliva biospecimen and to participate in the study of genetic variation influencing pain and opioid responsiveness phenotypes ("the study"), an informed consent letter to participate in the study and an Oragene™ DNA Self-Collection Kit, in disk format OG-250 (DNA Genotek, Inc., Ottowa, Ontario, Canada) will be sent to the participant by the Principal Investigator. According to the manufacturer instructions, participants will provide a 2 ml saliva sample, which will be preserved using the reagents provided within the Oragene kit. Saliva samples are considered stable at room temperature for 5 years by Oragene.

Estimated Enrollment: 500
Study Start Date: February 2009
Estimated Study Completion Date: December 2012
Estimated Primary Completion Date: December 2012 (Final data collection date for primary outcome measure)
Detailed Description:

The investigators hope to find a genetic association with various physiologic responses to opioid medication in patients who suffer from chronic pain (e.g. OIH vs. analgesic tolerance, baseline pain sensitivity, etc.). This has never been done before, and if it proves successful, it could provide physicians a greater understanding of why some chronic opioid users continue needing increased doses of opioids. This data may also help predict which patients will do well with chronic opioid therapy and which ones may not. Initial data with OPRM1 gene analysis in humans already implicates certain SNPs with opioid responsiveness and there have been suggestions for screening patients for OPRM1 prior to initiating opioid therapy in order to optimize their treatment response (Reynolds et al., 2008).

Clin Lab Med. 2008 Dec;28(4):581-98. The value of CYP2D6 and OPRM1 pharmacogenetic testing for opioid therapy. Reynolds KK, Ramey-Hartung B, Jortani SA.


Ages Eligible for Study:   18 Years to 71 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

Any gender, ages 18-70, of any ethnic background


Inclusion Criteria:

  1. Adult patient, aged 18-71
  2. Recipient of chronic opioid therapy
  3. Patient is able to produce a saliva sample
  4. If a past study participant, patient will have agreed to be contacted for future studies.

Exclusion Criteria:

a. not meeting inclusion criteria

  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its identifier: NCT01293994

United States, California
Stanford University School of Medicine
Stanford, California, United States, 94305
Sponsors and Collaborators
Stanford University
Principal Investigator: Dr Larry Fu-nien Chu Stanford University
  More Information

No publications provided

Responsible Party: Larry Fu-nien Chu, Associate Professor of Anesthesia, Stanford University Identifier: NCT01293994     History of Changes
Other Study ID Numbers: SU-11222010-7229, IRB #16198
Study First Received: February 9, 2011
Last Updated: February 13, 2012
Health Authority: United States: Institutional Review Board

Keywords provided by Stanford University:
Chronic Pain, DNA Collection, Genetic Variation, Opioid Medications, Pain processed this record on March 03, 2015