The Utility of Genetic Testing in Predicting Drug Response in Chronic Pain
试验速览
- 阶段
- 不适用
- 状态
- 暂停
- 入组人数
- 400
- 试验地点
- 1
- 主要终点
- Sensitivity and Specificity of PGx testing for pain response
研究概览
简要总结
Understanding the impact of genetics could aid rational, precision drug choices. In the current study, investigators will focus on whether genetic analysis of drug processing using the Inagene platform could predict efficacy and side effect profile in patients prescribed medication for pain.
详细描述
Understanding the impact of genetics could aid rational, precision drug choices. In the current study, investigators will focus on whether genetic analysis of drug processing using the Inagene platform could predict efficacy and side effect profile in patients prescribed medication for pain. In the investigator's clinic commonly employed medications included nortriptyline, duloxetine, topiramate, gabapentin, pregabalin, opioids (morphine derivatives, tramadol, tapentadol, buprenorphine patch), cesamet (a synthetic cannabinoid). To the investigator's knowledge this type of study has not been completed in this environment and/or patient population.
Research Objectives:
The main goal of this study is to determine whether genetic analysis of drug processing could help predict efficacy and side effect profiles of medications in a cohort of patients suffering from chronic pain.
In order to control for various clinical factors, patient reported outcomes will also be collected. As a standard part of any patient intake, pain diagrams, measures of pain, function, mental health status and exercise describe the conditions and relative impact will be included. Investigators will include various standardized and/or adapted versions of other questionnaires which will allow investigators to control for known confounders.
The following information will be collected at baseline
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 60 Years(Adult)
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •male and female between 18 and 60 years old
- •seen within the CFO-P
- •diagnosed by a physician with one or more chronic pain condition.
排除标准
- •adults who are unable to give their own consent
- •contraindications to a buccal swab
- •uncontrolled mental health issues determined by clinical judgement without mental health treatment and/or presence of active suicidal ideation
结局指标
主要结局
Sensitivity and Specificity of PGx testing for pain response
时间窗: up to 8 weeks post initial medication prescription
For the main analysis, the phenotypes will be grouped 1\&2 (do not prescribe) and 3\&4 (prescribe) and compared against whether patient responded or not to determine sensitivity and specificity of the genetic testing. Sub-analysis will determine for those that did not respond and whether this was a result of side effects or a lack of efficacy
次要结局
- Sensitivity and Specificity of PGx testing for side effects(up to 8 weeks post initial medication prescription)
研究者
Gaurav Gupta
Principal Investigator
Canadian Forces Health Services Centre Ottawa
