Determining Genetic Biomarkers Predictive of the Development of Prescription Opioid Addiction
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.
Usage of Prescription Opioids
|Study Design:||Observational Model: Case Control
Time Perspective: Retrospective
|Official Title:||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|
- mRNA Levels [ Time Frame: 1 day ] [ Designated as safety issue: No ]mRNA levels for all known genes and exons
- FTQ [ Time Frame: 1 day ] [ Designated as safety issue: No ]Family Tree Questionnaire
- TEQ [ Time Frame: 1 day ] [ Designated as safety issue: No ]Trauma Exposure Questionnare
- LSQ [ Time Frame: 1 day ] [ Designated as safety issue: No ]Life Stress Questionnaire
- POCS [ Time Frame: 1 day ] [ Designated as safety issue: No ]Prescription Opioid Craving Scale
- POAQ [ Time Frame: 1 day ] [ Designated as safety issue: No ]Prescription Opioid Analgesic Questionnaire
- mARCI [ Time Frame: 1 day ] [ Designated as safety issue: No ]Modified Addiction Research Center Inventory
- MINI [ Time Frame: 1 day ] [ Designated as safety issue: No ]Mini International Neuropsychiatric Interview
Biospecimen Retention: Samples With DNA
One tube (2.5-5.0 mL) of blood will be drawn from each subject during the visit for mRNA testing
|Study Start Date:||April 2012|
|Estimated Study Completion Date:||December 2013|
|Estimated Primary Completion Date:||December 2013 (Final data collection date for primary outcome measure)|
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.
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).
Please refer to this study by its ClinicalTrials.gov identifier: NCT01562353
|Contact: Kcennia Sacramed, BSc||781-444-9605 ext firstname.lastname@example.org|
|Contact: Stephen L Wright, MD||781-444-9605 ext email@example.com|
|United States, Massachusetts|
|Natick, Massachusetts, United States, 01760|
|Contact: Kcennia Sacramed, BSc 781-444-9605 ext 127 firstname.lastname@example.org|
|Principal Investigator: Nathaniel P Katz, MD, MS|
|Sub-Investigator: Stephen L Wright, MD|
|Sub-Investigator: Stephen J Glatt, PhD|
|Sub-Investigator: Alice Brown, MD|
|Principal Investigator:||Nathaniel P Katz, MD, MS||Analgesic Solutions|