Clinical trial NCT04223609: Non-intrusive Detection of Temporary Neurologic Impairment By Opioids
Official title: Non-intrusive Detection of Temporary Neurologic Impairment By Opioids
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
PHASE2
Conditions: Healthy
Lead sponsor: Mayo Clinic
Sponsor class: OTHER
First posted: 2020-01-10
Enrollment: 14
Sex: ALL
Minimum age (years): 21
Maximum age (years): 59
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: BASIC_SCIENCE

Brief summary: 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.


Eligibility criteria: Inclusion Criteria:

* 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

Exclusion Criteria:

* 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.

Primary outcomes:
measure: Oculo-Cognitive Addition Test (OCAT) Completion Time
timeFrame: Baseline, post initial dose (approximately 30 minutes) and post second dose (approximately 30 minutes)
measure: Saccadic Latency
timeFrame: Baseline, post initial dose (approximately 30 minutes) and post second dose (approximately 30 minutes)
measure: Fixation Time - Low Cognitive Workload
timeFrame: Baseline, post initial dose (approximately 30 minutes) and post second dose (approximately 30 minutes)
measure: Fixation Time - Medium Cognitive Workload
timeFrame: Baseline, post initial dose (approximately 30 minutes) and post second dose (approximately 30 minutes)
measure: Fixation Time - High Cognitive Workload
timeFrame: Baseline, post initial dose (approximately 30 minutes) and post second dose (approximately 30 minutes)
measure: Diagonal Saccadic Velocity
timeFrame: Baseline, post initial dose (approximately 30 minutes) and post second dose (approximately 30 minutes)
measure: Horizontal Saccadic Velocity
timeFrame: Baseline, post initial dose (approximately 30 minutes) and post second dose (approximately 30 minutes)
measure: Vertical Saccadic Velocity
timeFrame: Baseline, post initial dose (approximately 30 minutes) and post second dose (approximately 30 minutes)
Secondary outcomes:
Other outcomes:
Locations:
city: Scottsdale
country: United States
facility: Mayo Clinic in Arizona
state: Arizona
Study officials:
affiliation: Mayo Clinic
name: Gaurav Pradhan, PhD
role: PRINCIPAL_INVESTIGATOR
References: