NCT01562353Unknown不适用
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
Analgesic Solutions1 个研究点 分布在 1 个国家目标入组 30 人开始时间: 2012年4月最近更新:
适应症
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 30
- 试验地点
- 1
- 主要终点
- mRNA Levels
研究概览
简要总结
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.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Control
- 时间视角
- Retrospective
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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.
- •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.
- •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).
排除标准
- •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.
结局指标
主要结局
mRNA Levels
时间窗: 1 day
mRNA levels for all known genes and exons
次要结局
- FTQ(1 day)
- TEQ(1 day)
- LSQ(1 day)
- POCS(1 day)
- POAQ(1 day)
- MINI(1 day)
- mARCI(1 day)
研究者
研究点 (1)
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