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

NCT ID: NCT01293994

Last Updated: 2016-11-22

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

WITHDRAWN

Study Classification

OBSERVATIONAL

Study Start Date

2009-02-28

Study Completion Date

2012-12-31

Brief Summary

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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

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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.

Conditions

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Pain

Keywords

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Chronic Pain, Genetic Variation, Opioid Medications, Pain

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

71 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Stanford University

OTHER

Sponsor Role lead

Responsible Party

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Larry Fu-nien Chu

Professor of Anesthesia

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Dr Larry Fu-nien Chu

Role: PRINCIPAL_INVESTIGATOR

Stanford University

Locations

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Stanford University School of Medicine

Stanford, California, United States

Site Status

Countries

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United States

Other Identifiers

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IRB #16198

Identifier Type: OTHER

Identifier Source: secondary_id

SU-11222010-7229

Identifier Type: -

Identifier Source: org_study_id