The impairing effects of recreational nitrous oxide use on psychomotor functioning related to driving performance and its relation to detected concentration in exhaled air
Conditions
Interventions
Trade Name: Niontix
Product Name: Niontix
Pharmaceutical Form: Medicinal gas, liquefied
INN or Proposed INN: Nitrous oxide
CAS Number: 10024-97-2
Other descriptive name: NITROUS OXIDE
Concentration un
Sponsors
Maastricht University
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: - Have reached the age of 18 years or older. - Being in good physical and mental health as determined by a medical questionnaire and medical examination by a physician. - Have experience with the use of nitrous oxide ( =1 moment in the past with at least 1x =2 consecutive doses). - Experience with the method of administration (100% N2O bolus via balloon inhalation). - Be fully vaccinated against sars-cov-2 at least 14 days prior to the first physical encounter. Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 36 F.1.3 Elderly (>=65 years) no F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: - Use of nitrous oxide at >10 different times in the past year and/or have used >10 recreational doses (i.e. >10 balloons filled with 3 - 8 liters, 100% nitrous oxide) per time. These limits describe 80% of recreational users (van Amsterdam et al., 2015). Adherence to these limits avoids the inclusion of excessive users whose psychomotor functioning may be impaired by neuropathy associated with excessive use. - Recent use of sedating, stimulating or dissociating drugs. This is assessed by questioning and possibly requesting patient records from GPs. - Recent use of other common intoxicants determined through a urine test at the start of the training and test days (Surestep™ urine drug screen casette for amphetamines, benzodiazepines, cocaine, methamphetamines, morphine, THC). - Recent use of alcohol as determined by a positive breath test. - Excessive use of alcohol (=21 standard glasses per week for men or =14 standard glasses per week for women) - Pregnancy (determined by Alere™ urine hCG test at start of first day of testing) and/or not using any contraceptives for women of childbearing potential - Latex allergy.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: Answer the question: How long after the use of a typical recreational dose of nitrous oxide (4 liters, 100%, bolus administration via inhalation) is there a measurable negative impact on psychomotor functioning? ;Secondary Objective: Answer the following research questions: - Do successive doses have a cumulative impact on psychomotor functioning? - Is there a demonstrable relationship between the measured concentration of N2O, in exhaled air, and psychomotor functioning related to driving ability? o If so, at what concentrations is there a noticeable deterioration of psychomotor function, i.e. what is the threshold value? o If yes, until how long after use are the (relevant) concentrations detectable? - Based on the measured concentrations in the exhaled air, can it be determined at what moment nitrous oxide was used and/or can the period be defined within which the driver will in all likelihood experience limitations with regard to driving ability due to the use of N2O? In other words: what is the relation between the time of concentration in exhaled air and psychomotor performance.;Primary end point(s): - Tracking error in mm during divided attention task (DAT) - Reaction times after appearance of target stimuli during divided attention task (DAT) ;Timepoint(s) of evaluation of this end point: Timepoint 1: start assessment within 5 minutes after administration (duration 12 minutes) Timepoint 2: start assessment within 25 minutes after administration (duration 12 minutes) Timepoint 3: start assessement within 45 minutes after administration (duration 12 minutes) | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): - Number of correct answers during digit-symbol substitution test (DSST) - Time required for completion of trailmaking test (TMT) - Intensity or applicability of subjective experiences in mm as indicated on different visual analog scales (VAS) - N2O concentration in exhaled air ;Timepoint(s) of evaluation of this end point: - DSST and TMT: 60 minutes after administration - VAS: -4min, +15minutes, +35minutes, +55mintes, +75 minutes relative to drug administration - N20 concentrations in exhaled air: -20minutes, -8minutes, +1minute, +13minutes, +21minutes, +33minutes, +41minutes, +53minutes, +71minutes relative to drug administration | — |
Countries
Netherlands
Contacts
Public Contactfpn-lachgasonderzoek
Maastricht University
Outcome results
None listed