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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. | ||
| 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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| Measure | Description | Time Frame |
|---|---|---|
| mRNA Levels | mRNA levels for all known genes and exons | 1 day |
| Measure | Description | Time Frame |
|---|---|---|
| FTQ | Family Tree Questionnaire | 1 day |
| TEQ | Trauma Exposure Questionnare | 1 day |
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Inclusion Criteria:
Cases:
Controls:
Exclusion Criteria:
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A sample of 15 subjects per group will be sought. Cases and Controls will be selected by a community-based advertising program supplemented by referrals from clinicians.
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Kcennia Sacramed, BSc | Contact | 781-444-9605 | 127 | ksacramed@analgesicsolutions.com |
| Stephen L Wright, MD | Contact | 781-444-9605 | 101 | swright@analgesicsolutions.com |
| Name | Affiliation | Role |
|---|---|---|
| Nathaniel P Katz, MD, MS | Analgesic Solutions | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Analgesic Solutions | Recruiting | Natick | Massachusetts | 01760 | United States |
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| ID | Term |
|---|---|
| D009293 | Opioid-Related Disorders |
| ID | Term |
|---|---|
| D000079524 | Narcotic-Related Disorders |
| D019966 | Substance-Related Disorders |
| D064419 | Chemically-Induced Disorders |
| D001523 | Mental Disorders |
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One tube (2.5-5.0 mL) of blood will be drawn from each subject during the visit for mRNA testing
| LSQ | Life Stress Questionnaire | 1 day |
| POCS | Prescription Opioid Craving Scale | 1 day |
| POAQ | Prescription Opioid Analgesic Questionnaire | 1 day |
| mARCI | Modified Addiction Research Center Inventory | 1 day |
| MINI | Mini International Neuropsychiatric Interview | 1 day |