Determining Genetic Biomarkers Predictive of the Development of Prescription Opioid Addiction
A Pilot Study to Determine the Genetic Biomarkers Predictive of the Development of Prescription Opioid Addiction in Patients Treated for Pain Using a Comparative Transcriptomic Analysis of Gene Expression in Peripheral Blood Cells
1 other identifier
observational
30
1 country
1
Brief Summary
This is a clinical study on patients who have been prescribed opioids (narcotic pain relievers) for the treatment of pain, to determine what genetic factors influence outcome of treatment. Procedures include: an initial telephone prescreening, completion of a number of questionnaires, and a blood draw to determine genetic factors. Participants will take part in a one-time clinic visit, during which all procedures will be completed. The investigators hypothesize that several classes of genes, including genes in opioid, pain, and reward pathways, will differentiate opioid-dependent subjects from opioid-exposed nondependent subjects.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for all trials
Started Apr 2012
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
March 22, 2012
CompletedFirst Posted
Study publicly available on registry
March 23, 2012
CompletedStudy Start
First participant enrolled
April 1, 2012
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2013
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2013
CompletedSeptember 16, 2013
September 1, 2013
1.7 years
March 22, 2012
September 13, 2013
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
mRNA Levels
mRNA levels for all known genes and exons
1 day
Secondary Outcomes (7)
FTQ
1 day
TEQ
1 day
LSQ
1 day
POCS
1 day
POAQ
1 day
- +2 more secondary outcomes
Study Arms (2)
Case
Subject has a diagnosis of current prescription opioid dependence (confirmed by the MINI). Subject had no history of dependence on alcohol or illicit or prescription drugs, including opioids, prior to prescription opioid exposure for the treatment of chronic pain.
Control
Subject's prescribing physician has reported absence of significant problematic behavior with respect to prescription opioids or other substances while under the physician's care. Subject has a negative urine drug screen for alcohol, illicit drugs, and nonprescribed controlled substances at screening. Subject has no current or past substance abuse or dependence (confirmed by the MINI and medical history).
Eligibility Criteria
A sample of 15 subjects per group will be sought. Cases and Controls will be selected by a community-based advertising program supplemented by referrals from clinicians.
You may qualify if:
- Subject is 18 years or older.
- Subject is willing and able to speak, read, and write in English and comply with all study procedures.
- Subject is willing and able to voluntarily sign and date an Informed Consent Form (ICF), approved by an Institutional Review Board (IRB), prior to the conduct of any study-specific procedures.
- Subject has been prescribed opioids for the treatment of pain for at least 6 months at the time of the study.
- Cases:
- Subject has a diagnosis of current prescription opioid dependence (confirmed by the MINI).
- Subject had no history of dependence on alcohol or illicit or prescription drugs, including opioids, prior to prescription opioid exposure for the treatment of chronic pain. Patients who have abused these substances but have not met criteria for dependence (confirmed by the MINI and/or medical history) will be included.
- Controls:
- Subject's prescribing physician has reported absence of significant problematic behavior with respect to prescription opioids or other substances while under the physician's care.
- Subject has a negative urine drug screen for alcohol, illicit drugs, and nonprescribed controlled substances at screening.
- Subject has no current or past substance abuse or dependence (confirmed by the MINI and medical history).
You may not qualify if:
- Subject has any condition that poses undo study-related risk, or that interferes with assessment.
- Subject is not willing to have blood drawn or has any condition that in the investigators' opinion precludes having blood drawn.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Analgesic Solutions
Natick, Massachusetts, 01760, United States
Biospecimen
One tube (2.5-5.0 mL) of blood will be drawn from each subject during the visit for mRNA testing
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Nathaniel P Katz, MD, MS
Analgesic Solutions
Central Study Contacts
Study Design
- Study Type
- observational
- Observational Model
- CASE CONTROL
- Time Perspective
- RETROSPECTIVE
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
March 22, 2012
First Posted
March 23, 2012
Study Start
April 1, 2012
Primary Completion
December 1, 2013
Study Completion
December 1, 2013
Last Updated
September 16, 2013
Record last verified: 2013-09