A Study of Genetic Variation Influencing Pain and Respons... | NCT01293994

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

NCT01293994

Sponsor

Stanford University

Status

Withdrawn

Last Update Posted

Nov 22, 2016Estimated

Enrollment

0Actual

Phase

Not provided

Conditions

Pain

Interventions

Not provided

Countries

United States

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

ID	Type	Description	Link
IRB #16198	Other Identifier	Stanford University Panel on Human Subjects

Status Module

Record Verification Date

Nov 2016

Overall Recruitment Status or Expanded Access Status

Withdrawn

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Do not have necessary resources to continue

Expanded Access Info

Start Date

Feb 2009

Primary Completion Date

Dec 2012Actual

Completion Date

Dec 2012Actual

First Submitted Date

Feb 9, 2011

First Submission Date that Met QC Criteria

Feb 10, 2011

First Posted Date

Feb 11, 2011Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Nov 18, 2016

Last Update Posted Date

Nov 22, 2016Estimated

Sponsor/Collaborators Module

Responsible Party, by Official Title

Larry Fu-nien Chu, Professor of Anesthesia, Stanford UniversityPrincipal Investigator

Lead Sponsor

Stanford UniversityOTHER

Collaborators

Not provided

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

Retention

Enrollment

0Actual

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Genetic association with various physiologic responses to opioid medication in patients		Up to 5 years

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

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.

Exclusion Criteria:

a. not meeting inclusion criteria

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

71 Years

Standard Ages

AdultOlder Adult

Study Population

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

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Dr Larry Fu-nien Chu	Stanford University	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Stanford University School of Medicine		Stanford	California	94305	United States

IPD Sharing Statement Module

Plan to Share IPD

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D010146	Pain
D059350	Chronic Pain

Ancestor Terms

ID	Term
D009461	Neurologic Manifestations
D012816	Signs and Symptoms
D013568	Pathological Conditions, Signs and Symptoms

Browse Leaves

Not provided

Browse Branches

Not provided

Description

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™.