Determining Genetic Biomarkers Predictive of the Development of Prescription Opioid Addiction
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|ClinicalTrials.gov Identifier: NCT01562353|
Recruitment Status : Unknown
Verified September 2013 by Analgesic Solutions.
Recruitment status was: Recruiting
First Posted : March 23, 2012
Last Update Posted : September 16, 2013
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.
|Condition or disease|
|Usage of Prescription Opioids|
|Study Type :||Observational|
|Estimated Enrollment :||30 participants|
|Observational Model:||Case Control|
|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|
|Study Start Date :||April 2012|
|Estimated Primary Completion Date :||December 2013|
|Estimated Study Completion Date :||December 2013|
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).
- mRNA Levels [ Time Frame: 1 day ]mRNA levels for all known genes and exons
- FTQ [ Time Frame: 1 day ]Family Tree Questionnaire
- TEQ [ Time Frame: 1 day ]Trauma Exposure Questionnare
- LSQ [ Time Frame: 1 day ]Life Stress Questionnaire
- POCS [ Time Frame: 1 day ]Prescription Opioid Craving Scale
- POAQ [ Time Frame: 1 day ]Prescription Opioid Analgesic Questionnaire
- mARCI [ Time Frame: 1 day ]Modified Addiction Research Center Inventory
- MINI [ Time Frame: 1 day ]Mini International Neuropsychiatric Interview
Biospecimen Retention: Samples With DNA
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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|