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NCT01293994 Clinical Trial

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

Pain Clinical Trial

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

Clinical Trial Details — Status: Withdrawn

Administrative data
NCT number NCT01293994
Other study ID # SU-11222010-7229
Secondary ID IRB #16198
Status Withdrawn
Phase N/A
First received February 9, 2011
Last updated November 18, 2016
Start date February 2009
Est. completion date December 2012

Study information
Verified date November 2016
Source Stanford University
Contact n/a
Is FDA regulated No
Health authority United States: Institutional Review Board
Study type Observational

Clinical Trial 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.

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.

Recruitment information / eligibility
Status Withdrawn
Enrollment 0
Est. completion date December 2012
Est. primary completion date December 2012
Accepts healthy volunteers No
Gender Both
Age group 18 Years to 71 Years
Eligibility 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

Study Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

Locations
Country Name City State
United States Stanford University School of Medicine Stanford California

Sponsors (1)
Lead Sponsor Collaborator
Stanford University

Country where clinical trial is conducted

United States, 

Outcome
Type Measure Description Time frame Safety issue
Primary Genetic association with various physiologic responses to opioid medication in patients Up to 5 years No
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