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
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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 |
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Usage of Prescription Opioids |
Study Type : | Observational |
Estimated Enrollment : | 30 participants |
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 |
Study Start Date : | April 2012 |
Estimated Primary Completion Date : | December 2013 |
Estimated Study Completion Date : | December 2013 |

Group/Cohort |
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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.
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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).
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- 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

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Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
Sampling Method: | Non-Probability Sample |
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.

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 127 | ksacramed@analgesicsolutions.com | |
Contact: Stephen L Wright, MD | 781-444-9605 ext 101 | swright@analgesicsolutions.com |
United States, Massachusetts | |
Analgesic Solutions | Recruiting |
Natick, Massachusetts, United States, 01760 | |
Contact: Kcennia Sacramed, BSc 781-444-9605 ext 127 ksacramed@analgesicsolutions.com | |
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 |
Responsible Party: | Analgesic Solutions |
ClinicalTrials.gov Identifier: | NCT01562353 |
Other Study ID Numbers: |
CPH.CSA.0005 |
First Posted: | March 23, 2012 Key Record Dates |
Last Update Posted: | September 16, 2013 |
Last Verified: | September 2013 |
Opioid Dependence Opioids for the treatment of pain |
Opioid-Related Disorders Narcotic-Related Disorders Substance-Related Disorders Chemically-Induced Disorders Mental Disorders |