Determining Genetic Biomarkers Predictive of the Development of Prescription Opioid Addiction

• Conditions: Usage of Prescription Opioids

• Registration Number: NCT01562353
• Lead Sponsor: Analgesic Solutions

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2012-03-22
• Study First Submitted QC: 2012-03-22
• Study First Posted: 2012-03-23
• Study Start: 2012-04
• Status Verified: 2013-09
• Last Update Submitted: 2013-09-13
• Last Update Posted: 2013-09-16
• Primary Completion: 2013-12
• Study Completion: 2013-12

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 30

Inclusion Criteria

• 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).

Exclusion Criteria

• 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.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
mRNA Levels	1 day	mRNA levels for all known genes and exons

Secondary Outcome Measures

Name	Time	Method
FTQ	1 day	Family Tree Questionnaire
TEQ	1 day	Trauma Exposure Questionnare
LSQ	1 day	Life Stress Questionnaire
POCS	1 day	Prescription Opioid Craving Scale
POAQ	1 day	Prescription Opioid Analgesic Questionnaire
MINI	1 day	Mini International Neuropsychiatric Interview
mARCI	1 day	Modified Addiction Research Center Inventory

Trial Locations

Locations (1)

Analgesic Solutions; 🇺🇸 Natick, Massachusetts, United States