Determining Genetic Biomarkers Predictive of the Development of Prescription Opioid Addiction
NCT ID: NCT01562353
Last Updated: 2013-09-16
Study Results
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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UNKNOWN
30 participants
OBSERVATIONAL
2012-04-30
2013-12-31
Brief Summary
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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.
Detailed Description
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Conditions
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Keywords
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Study Design
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CASE_CONTROL
RETROSPECTIVE
Study Groups
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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.
No interventions assigned to this group
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).
No interventions assigned to this group
Eligibility Criteria
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Inclusion Criteria
* 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).
Exclusion Criteria
* Subject is not willing to have blood drawn or has any condition that in the investigators' opinion precludes having blood drawn.
18 Years
ALL
No
Sponsors
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Analgesic Solutions
INDUSTRY
Responsible Party
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Principal Investigators
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Nathaniel P Katz, MD, MS
Role: PRINCIPAL_INVESTIGATOR
Analgesic Solutions
Locations
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Analgesic Solutions
Natick, Massachusetts, United States
Countries
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Central Contacts
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Facility Contacts
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Kcennia Sacramed, BSc
Role: primary
Other Identifiers
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CPH.CSA.0005
Identifier Type: -
Identifier Source: org_study_id