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

Withdrawn

• Conditions: Pain

• Registration Number: NCT01293994
• Lead Sponsor: 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.

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 Timeline

• Study Start: 2009-02
• Study First Submitted: 2011-02-09
• Study First Submitted QC: 2011-02-10
• Study First Posted: 2011-02-11
• Primary Completion: 2012-12
• Study Completion: 2012-12
• Status Verified: 2016-11
• Last Update Submitted: 2016-11-18
• Last Update Posted: 2016-11-22

Recruitment & Eligibility

• Status: WITHDRAWN
• Sex: All
• Target Recruitment: Not specified

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.

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Exclusion Criteria

a. not meeting inclusion criteria

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Genetic association with various physiologic responses to opioid medication in patients	Up to 5 years

Trial Locations

Locations (1)

Stanford University School of Medicine; 🇺🇸 Stanford, California, United States