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

NCT01293994 | Withdrawn

• 2 other identifiers: SU-11222010-7229IRB #16198
• Study Type: observational
• Target: N/A
• Locations: 1 country
• Sites: 1

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.

Conditions

Pain

Keywords

Chronic Pain, Genetic Variation, Opioid Medications, Pain

Outcome Measures

Primary Outcomes (1)

• Genetic association with various physiologic responses to opioid medication in patients

  Up to 5 years

Eligibility Criteria

• Age: 18 Years - 71 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

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

You may qualify if:

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

Sponsors & Collaborators

• Stanford University: lead

Study Sites (1)

Stanford University School of Medicine

Stanford, California, 94305, United States

Location

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™.

MeSH Terms

Conditions

Pain; Chronic Pain

Condition Hierarchy (Ancestors)

Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Dr Larry Fu-nien Chu

  Stanford University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor of Anesthesia

Study Record Dates

• First Submitted: February 9, 2011
• First Posted: February 11, 2011
• Study Start: February 1, 2009
• Primary Completion: December 1, 2012
• Study Completion: December 1, 2012
• Last Updated: November 22, 2016

Record last verified: 2016-11

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)