Usage of Prescription Opioids Clinical Trial
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
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.
| Status | Recruiting |
| Enrollment | 30 |
| Est. completion date | December 2013 |
| Est. primary completion date | December 2013 |
| Accepts healthy volunteers | No |
| Gender | Both |
| Age group | 18 Years and older |
| Eligibility |
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. |
Observational Model: Case Control, Time Perspective: Retrospective
| Country | Name | City | State |
|---|---|---|---|
| United States | Analgesic Solutions | Natick | Massachusetts |
| Lead Sponsor | Collaborator |
|---|---|
| Analgesic Solutions |
United States,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | mRNA Levels | mRNA levels for all known genes and exons | 1 day | No |
| Secondary | FTQ | Family Tree Questionnaire | 1 day | No |
| Secondary | TEQ | Trauma Exposure Questionnare | 1 day | No |
| Secondary | LSQ | Life Stress Questionnaire | 1 day | No |
| Secondary | POCS | Prescription Opioid Craving Scale | 1 day | No |
| Secondary | POAQ | Prescription Opioid Analgesic Questionnaire | 1 day | No |
| Secondary | mARCI | Modified Addiction Research Center Inventory | 1 day | No |
| Secondary | MINI | Mini International Neuropsychiatric Interview | 1 day | No |