A Study of Genetic Variation Influencing Pain and Response to Opioid Medications

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01293994
Recruitment Status : Withdrawn (Do not have necessary resources to continue)
First Posted : February 11, 2011
Last Update Posted : November 22, 2016
Information provided by (Responsible Party):
Larry Fu-nien Chu, Stanford University

Brief Summary:
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.

Condition or disease

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.

Study Type : Observational
Actual Enrollment : 0 participants
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
Study Start Date : February 2009
Actual Primary Completion Date : December 2012
Actual Study Completion Date : December 2012

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Chronic Pain

Primary Outcome Measures :
  1. Genetic association with various physiologic responses to opioid medication in patients [ Time Frame: Up to 5 years ]

Biospecimen Retention:   Samples With DNA
Saliva biospecimen collection will be performed via mail or in person. The PI 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, an informed consent letter and an Oragene™ DNA Self-Collection Kit, in disk format OG-250 (DNA Genotek, Inc., Ottawa, Ontario, Canada) will be sent to the participant by the PI. 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™.

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 71 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): 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

Responsible Party: Larry Fu-nien Chu, Professor of Anesthesia, Stanford University Identifier: NCT01293994     History of Changes
Other Study ID Numbers: SU-11222010-7229
IRB #16198 ( Other Identifier: Stanford University Panel on Human Subjects )
First Posted: February 11, 2011    Key Record Dates
Last Update Posted: November 22, 2016
Last Verified: November 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Keywords provided by Larry Fu-nien Chu, Stanford University:
Chronic Pain, Genetic Variation, Opioid Medications, Pain

Additional relevant MeSH terms:
Analgesics, Opioid
Central Nervous System Depressants
Physiological Effects of Drugs
Sensory System Agents
Peripheral Nervous System Agents