Non-intrusive Detection of Temporary Neurologic Impairment By Opioids
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- Mayo Clinic
- 入组人数
- 14
- 试验地点
- 1
- 主要终点
- Oculo-Cognitive Addition Test (OCAT) Completion Time
研究概览
简要总结
Research is being conducted to better understand the physiologic effects (relating to the action of a drug when taken by a healthy person) of opioid use on oculomotor (relating to the motion of the eye) dynamics and to identify the presence of characteristics consistent with a specific drug or class of drugs.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Basic Science
- 盲法
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 21 Years 至 59 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Participants must be able to consent to participate themselves
- •Be healthy male or non-pregnant female
- •Must be able to attend in-person sessions at the Mayo Aerospace Medicine and Vestibular Research Laboratory in Scottsdale, AZ.
- •Have not used opioids during the preceding 30 days
- •Prior use of opioids for pain management
排除标准
- •Women who are pregnant or breastfeeding.
- •Women who are not practicing an effective form of contraception (condoms, IUD, birth control pill, diaphragm),
- •Past or current history of drug or substance use.
- •Significant ocular disorder.
- •Positive drug test for marijuana, opioids, methamphetamines, cocaine, PCP or other controlled substances.
- •History of use of psychoactive drugs within the past 30 days.
- •Subjects with a history of cardiopulmonary disease including but not limited to congestive heart failure, obstructive sleep apnea, restrictive lung disease, COPD, moderate to severe asthma and oxygen dependency.
- •Subjects currently taking sedatives (including benzodiazepines), muscle relaxants or disassociatives.
研究组 & 干预措施
Oxycodone, Then Placebo
Participants first receive initial dose of oxycodone 5 mg tablet followed by a 30-minute rest period to allow for onset of medication effect. This rest period will be followed by a standardized set of oculomotor testing for 40 minutes. After the initial testing, a second dose of oxycodone 5 mg tablet will be administered followed by a 30-minute rest period to allow for the onset of the second dose. The second rest period will be followed by a second round of standardized oculomotor testing for 40 minutes. Participants will then return approximately 4 to 6 days to repeat the standardized oculomotor testing with placebo.
干预措施: Oxycodone (Drug)
Oxycodone, Then Placebo
Participants first receive initial dose of oxycodone 5 mg tablet followed by a 30-minute rest period to allow for onset of medication effect. This rest period will be followed by a standardized set of oculomotor testing for 40 minutes. After the initial testing, a second dose of oxycodone 5 mg tablet will be administered followed by a 30-minute rest period to allow for the onset of the second dose. The second rest period will be followed by a second round of standardized oculomotor testing for 40 minutes. Participants will then return approximately 4 to 6 days to repeat the standardized oculomotor testing with placebo.
干预措施: Placebo (Drug)
Oxycodone, Then Placebo
Participants first receive initial dose of oxycodone 5 mg tablet followed by a 30-minute rest period to allow for onset of medication effect. This rest period will be followed by a standardized set of oculomotor testing for 40 minutes. After the initial testing, a second dose of oxycodone 5 mg tablet will be administered followed by a 30-minute rest period to allow for the onset of the second dose. The second rest period will be followed by a second round of standardized oculomotor testing for 40 minutes. Participants will then return approximately 4 to 6 days to repeat the standardized oculomotor testing with placebo.
干预措施: EyeLink 1000 Plus (Device)
Oxycodone, Then Placebo
Participants first receive initial dose of oxycodone 5 mg tablet followed by a 30-minute rest period to allow for onset of medication effect. This rest period will be followed by a standardized set of oculomotor testing for 40 minutes. After the initial testing, a second dose of oxycodone 5 mg tablet will be administered followed by a 30-minute rest period to allow for the onset of the second dose. The second rest period will be followed by a second round of standardized oculomotor testing for 40 minutes. Participants will then return approximately 4 to 6 days to repeat the standardized oculomotor testing with placebo.
干预措施: Oculo-Cognitive Addition test (OCAT) (Diagnostic Test)
Oxycodone, Then Placebo
Participants first receive initial dose of oxycodone 5 mg tablet followed by a 30-minute rest period to allow for onset of medication effect. This rest period will be followed by a standardized set of oculomotor testing for 40 minutes. After the initial testing, a second dose of oxycodone 5 mg tablet will be administered followed by a 30-minute rest period to allow for the onset of the second dose. The second rest period will be followed by a second round of standardized oculomotor testing for 40 minutes. Participants will then return approximately 4 to 6 days to repeat the standardized oculomotor testing with placebo.
干预措施: VT3mini - Eye Tracking Technology for OEMs (Device)
Placebo, Then Oxycodone
Participants first receive initial dose of placebo 5 mg tablet followed by a 30-minute rest period to allow for onset of medication effect. This rest period will be followed by a set of standardized oculomotor testing for 40 minutes. After the initial testing, a second dose of placebo 5 mg tablet will be administered followed by a 30-minute rest period to allow for the onset of the second dose. The second rest period will be followed by a second round of standardized oculomotor testing for 40 minutes. Participants will then return approximately 4 to 6 days to repeat the standardized oculomotor testing with oxycodone.
干预措施: Oxycodone (Drug)
Placebo, Then Oxycodone
Participants first receive initial dose of placebo 5 mg tablet followed by a 30-minute rest period to allow for onset of medication effect. This rest period will be followed by a set of standardized oculomotor testing for 40 minutes. After the initial testing, a second dose of placebo 5 mg tablet will be administered followed by a 30-minute rest period to allow for the onset of the second dose. The second rest period will be followed by a second round of standardized oculomotor testing for 40 minutes. Participants will then return approximately 4 to 6 days to repeat the standardized oculomotor testing with oxycodone.
干预措施: Placebo (Drug)
Placebo, Then Oxycodone
Participants first receive initial dose of placebo 5 mg tablet followed by a 30-minute rest period to allow for onset of medication effect. This rest period will be followed by a set of standardized oculomotor testing for 40 minutes. After the initial testing, a second dose of placebo 5 mg tablet will be administered followed by a 30-minute rest period to allow for the onset of the second dose. The second rest period will be followed by a second round of standardized oculomotor testing for 40 minutes. Participants will then return approximately 4 to 6 days to repeat the standardized oculomotor testing with oxycodone.
干预措施: EyeLink 1000 Plus (Device)
Placebo, Then Oxycodone
Participants first receive initial dose of placebo 5 mg tablet followed by a 30-minute rest period to allow for onset of medication effect. This rest period will be followed by a set of standardized oculomotor testing for 40 minutes. After the initial testing, a second dose of placebo 5 mg tablet will be administered followed by a 30-minute rest period to allow for the onset of the second dose. The second rest period will be followed by a second round of standardized oculomotor testing for 40 minutes. Participants will then return approximately 4 to 6 days to repeat the standardized oculomotor testing with oxycodone.
干预措施: Oculo-Cognitive Addition test (OCAT) (Diagnostic Test)
Placebo, Then Oxycodone
Participants first receive initial dose of placebo 5 mg tablet followed by a 30-minute rest period to allow for onset of medication effect. This rest period will be followed by a set of standardized oculomotor testing for 40 minutes. After the initial testing, a second dose of placebo 5 mg tablet will be administered followed by a 30-minute rest period to allow for the onset of the second dose. The second rest period will be followed by a second round of standardized oculomotor testing for 40 minutes. Participants will then return approximately 4 to 6 days to repeat the standardized oculomotor testing with oxycodone.
干预措施: VT3mini - Eye Tracking Technology for OEMs (Device)
结局指标
主要结局
Oculo-Cognitive Addition Test (OCAT) Completion Time
时间窗: Baseline, post initial dose (approximately 30 minutes) and post second dose (approximately 30 minutes)
Time it takes participants to complete the OCAT measured in seconds.
Saccadic Latency
时间窗: Baseline, post initial dose (approximately 30 minutes) and post second dose (approximately 30 minutes)
measured in seconds
Fixation Time - Low Cognitive Workload
时间窗: Baseline, post initial dose (approximately 30 minutes) and post second dose (approximately 30 minutes)
measure in milliseconds
Fixation Time - Medium Cognitive Workload
时间窗: Baseline, post initial dose (approximately 30 minutes) and post second dose (approximately 30 minutes)
measure in milliseconds
Fixation Time - High Cognitive Workload
时间窗: Baseline, post initial dose (approximately 30 minutes) and post second dose (approximately 30 minutes)
measure in milliseconds
Diagonal Saccadic Velocity
时间窗: Baseline, post initial dose (approximately 30 minutes) and post second dose (approximately 30 minutes)
measured in deg/s
Horizontal Saccadic Velocity
时间窗: Baseline, post initial dose (approximately 30 minutes) and post second dose (approximately 30 minutes)
measured in deg/s
Vertical Saccadic Velocity
时间窗: Baseline, post initial dose (approximately 30 minutes) and post second dose (approximately 30 minutes)
measured in deg/s
次要结局
未报告次要终点
研究者
Gaurav N. Pradhan
Principal Investigator
Mayo Clinic