Primary Objective: To 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…
ID
Source
Brief title
Condition
- Other condition
Synonym
Health condition
Acute intoxicatie
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
- Tracking error in mm during divided attention task (DAT)
- Reaction times after appearance of target stimuli during divided attention
task (DAT)
Secondary outcome
- 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) and drug effects questionnaire (DEQ)
- N2O concentration in exhaled air in parts per million (ppm)
- Baseline nervousness determined as score on state-trait anxiety inventory,
state portion (STAI-S, questionnaire)
- Sleep quality during the previous night as score on Groningen Sleep Quality
Scale (GSQS, questionnaire)
- Task-related nervousness and metacognition as score on Dundee Stress State
Questionnaire (DSSQ, questionnaire)
- Time to start of computer tasks after cessation of drug administration
- Bispectral index during drug administration and task execution
- trait-impulsivity measured with barrat impulsiviness scale (BIS,
questionnaire)
- feelings of depression, anxiety or stress during the week prior to each
testing session, assessed with depression anxiety and stress scale (DASS,
questionnaire)
Background summary
Nitrous oxide, better known as laughing gas, is a widely used recreational drug
that is also frequently found in traffic. However, it is not known how long
after use the effects of nitrous oxide adversely affect driving ability.
Study objective
Primary Objective: To 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(s): Answer the following research questions:
- Do successive doses have a cumulative impact on psychomotor functioning?
- Is there a 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.
Study design
double-blind, randomized, placebo-controlled crossover trial
Intervention
Subjects go through three experimental conditions,i.e. placebo, a recreational
dose of nitrous oxide (4 liters 100% by inhalation), and a double recreational
dose of nitrous oxide.
Study burden and risks
A participation consists of 4 visits, namely one training session (2h) and
three test sessions (2,5h each). Prior to the training a medical examination
takes place on the basis of a medical questionnaire, a possible review of the
patient file of the participant, and telephone contact or video chat. Prior to
training and test sessions, a urine sample is requested for a drug test (and
pregnancy test for female participants) as well as an alcohol breath analysis.
During training and testing sessions, several questionnaires are administered
and psychomotor tasks (pen-and-paper and computer) are performed. Placebo
(medical air) or nitrous oxide is also administered to the participants during
the test sessions by inhalation through a balloon. The intended dosage and
method of administration of nitrous oxide can lead to short-term decrease in
consciousness, ataxia, and hypoxia. However, these effects are transient and
with no known risk of lasting effects to the participant. In addition, admitted
participants have previous experience with the intended route of administration
and dosage, and therefore effects, of nitrous oxide.
Universiteitssingel 40 Universiteitssingel 40
Maastricht 6229ER
NL
Universiteitssingel 40 Universiteitssingel 40
Maastricht 6229ER
NL
Listed location countries
Age
Inclusion criteria
- Age 18-64
- being in possession of a valid driver's licence (in the Netherlands)
- 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.
- Applicants who are not or incompletely vaccinated for sars-cov-2 can enroll
if they are willing to wear a face mask typ IIR during each visit (with the
exception of during drug administration)
Exclusion criteria
-use of nitrous oxide > 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
Recruitment
Medical products/devices used
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| EudraCT | EUCTR2021-003242-20-NL |
| CCMO | NL78086.068.21 |