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    Summary
    EudraCT Number:2021-003242-20
    Sponsor's Protocol Code Number:p135
    National Competent Authority:Netherlands - Competent Authority
    Clinical Trial Type:EEA CTA
    Trial Status:Ongoing
    Date on which this record was first entered in the EudraCT database:2022-01-28
    Trial results
    Index
    A. PROTOCOL INFORMATION
    B. SPONSOR INFORMATION
    C. APPLICANT IDENTIFICATION
    D. IMP IDENTIFICATION
    D.8 INFORMATION ON PLACEBO
    E. GENERAL INFORMATION ON THE TRIAL
    F. POPULATION OF TRIAL SUBJECTS
    G. INVESTIGATOR NETWORKS TO BE INVOLVED IN THE TRIAL
    N. REVIEW BY THE COMPETENT AUTHORITY OR ETHICS COMMITTEE IN THE COUNTRY CONCERNED
    P. END OF TRIAL
    Expand All   Collapse All
    A. Protocol Information
    A.1Member State ConcernedNetherlands - Competent Authority
    A.2EudraCT number2021-003242-20
    A.3Full title of the trial
    Effects of recreational nitrous oxide use on psychomotor functioning related to driving performance
    Effecten van recreatief lachgasgebruik op psychomotorisch functioneren gerelateerd aan rijvaardigheid
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Effects of recreational nitrous oxide use on psychomotor functioning related to driving performance
    Effecten van recreatief lachgasgebruik op psychomotorisch functioneren gerelateerd aan rijvaardigheid
    A.3.2Name or abbreviated title of the trial where available
    psychomotor effects of nitrous oxide
    psychomotorische effecten van lachgas
    A.4.1Sponsor's protocol code numberp135
    A.7Trial is part of a Paediatric Investigation Plan No
    A.8EMA Decision number of Paediatric Investigation Plan
    B. Sponsor Information
    B.Sponsor: 1
    B.1.1Name of SponsorMaastricht University
    B.1.3.4CountryNetherlands
    B.3.1 and B.3.2Status of the sponsorNon-Commercial
    B.4 Source(s) of Monetary or Material Support for the clinical trial:
    B.4.1Name of organisation providing supportPolitieacademie
    B.4.2CountryNetherlands
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationMaastricht University
    B.5.2Functional name of contact pointfpn-lachgasonderzoek
    B.5.3 Address:
    B.5.3.1Street AddressPostbus 616
    B.5.3.2Town/ cityMaastricht
    B.5.3.3Post code6200MD
    B.5.3.4CountryNetherlands
    B.5.6E-mailfpn-lachgasonderzoek@maastrichtuniversity.nl
    D. IMP Identification
    D.IMP: 1
    D.1.2 and D.1.3IMP RoleTest
    D.2 Status of the IMP to be used in the clinical trial
    D.2.1IMP to be used in the trial has a marketing authorisation Yes
    D.2.1.1.1Trade name Niontix
    D.2.1.1.2Name of the Marketing Authorisation holderLinde Gas Therapeutics Benelux BV
    D.2.1.2Country which granted the Marketing AuthorisationNetherlands
    D.2.5The IMP has been designated in this indication as an orphan drug in the Community No
    D.2.5.1Orphan drug designation number
    D.3 Description of the IMP
    D.3.1Product nameNiontix
    D.3.4Pharmaceutical form Medicinal gas, liquefied
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPInhalation use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNNitrous oxide
    D.3.9.1CAS number 10024-97-2
    D.3.9.3Other descriptive nameNITROUS OXIDE
    D.3.9.4EV Substance CodeSUB03447MIG
    D.3.10 Strength
    D.3.10.1Concentration unit % percent
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number100
    D.3.11 The IMP contains an:
    D.3.11.1Active substance of chemical origin Yes
    D.3.11.2Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP) No
    The IMP is a:
    D.3.11.3Advanced Therapy IMP (ATIMP) No
    D.3.11.3.1Somatic cell therapy medicinal product No
    D.3.11.3.2Gene therapy medical product No
    D.3.11.3.3Tissue Engineered Product No
    D.3.11.3.4Combination ATIMP (i.e. one involving a medical device) No
    D.3.11.3.5Committee on Advanced therapies (CAT) has issued a classification for this product No
    D.3.11.4Combination product that includes a device, but does not involve an Advanced Therapy No
    D.3.11.5Radiopharmaceutical medicinal product No
    D.3.11.6Immunological medicinal product (such as vaccine, allergen, immune serum) No
    D.3.11.7Plasma derived medicinal product No
    D.3.11.8Extractive medicinal product No
    D.3.11.9Recombinant medicinal product No
    D.3.11.10Medicinal product containing genetically modified organisms No
    D.3.11.11Herbal medicinal product No
    D.3.11.12Homeopathic medicinal product No
    D.3.11.13Another type of medicinal product No
    D.8 Information on Placebo
    D.8 Placebo: 1
    D.8.1Is a Placebo used in this Trial?Yes
    D.8.3Pharmaceutical form of the placeboMedicinal gas, compressed
    D.8.4Route of administration of the placeboInhalation use
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    The impairing effects of recreational nitrous oxide use on psychomotor functioning related to driving performance and its relation to detected concentration in exhaled air
    De schadelijke effecten van recreatief gebruik van distikstofmonoxide op het psychomotorisch functioneren in verband met rijvaardigheid en het verband met de gedetecteerde concentratie in de uitgeademde lucht
    E.1.1.1Medical condition in easily understood language
    The intoxicating effects of recreational nitrous oxide use on functions necessary for driving a car and its relationship to measured values of nitrous oxide in exhaled air
    De bedwelmende effecten van recreatief lachgasgebruik op functies nodig voor het besturen van een auto en de relatie hiervan tot gemeten waarden van lachgas in uitgeademde lucht
    E.1.1.2Therapeutic area Psychiatry and Psychology [F] - Behavioral Disciplines and Activities [F04]
    MedDRA Classification
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    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?
    Beantwoorden van de vraag: Hoelang na het gebruik van een typische recreatieve dosering lachgas (4 liter, 100%, bolus toediening via inhalatie) is er een meetbare negatieve weerslag op psychomotorisch functioneren aantoonbaar?
    E.2.2Secondary objectives of the trial
    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.
    Beantwoorden van de volgende onderzoeksvragen:
    - Hebben opeenvolgende doseringen een cumulatieve impact op psychomotorisch functioneren?
    - Is er een verband aantoonbaar tussen de gemeten concentratie N2O, in uitgeademde lucht, en psychomotorisch functioneren gerelateerd aan rijvaardigheid?
    o Zo ja, bij welke concentraties is er een verslechtering van psychomotorisch functioneren waarneembaar, m.a.w. wat is de grenswaarde?
    o Zo ja, tot hoelang na gebruik zijn de (relevante) concentraties aantoonbaar?
    - Kan er op basis van de gemeten concentraties in de uitgeademde lucht worden bepaald op welk moment lachgas is gebruikt en/of kan de periode worden afgebakend waarbinnen de chauffeur naar grote waarschijnlijkheid beperkingen zal ervaren aangaande rijvaardigheid door het gebruik van N2O? M.a.w. wat is de relatie tussen het tijdsverloop van concentratie in uitgeademde lucht en psychomotorisch prestatie.
    E.2.3Trial contains a sub-study No
    E.3Principal 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.
    - De leeftijd van 18 jaar of ouder hebben bereikt.
    - Verkeren in goede fysieke en mentale gezondheid zoals bepaald d.m.v. een medische vragenlijst en medische keuring door een arts.
    - Ervaring hebben met het gebruik van lachgas ( ≥1 moment in het verleden met minstens 1x ≥2 opeenvolgende doseringen).
    - Ervaring met de wijze van toediening (100% N2O bolus via ballon inhaleren)
    - Volledige gevaccineerd zijn tegen sars-cov-2, ten laatste 14 dagen voor de eerste fysieke ontmoeting
    E.4Principal 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.
    - Gebruik van lachgas op >10 verschillende momenten in het afgelopen jaar en/of per moment >10 recreatieve dosissen (i.e. >10 ballonnen gevuld met 3 – 8 liter, 100% lachgas) te hebben gebruikt. Deze limieten beschrijven 80% van de recreatieve gebruikers (van Amsterdam et al., 2015). Het hanteren van deze limieten vermijdt dat er excessieve gebruikers worden geïncludeerd waarvan psychomotorisch functioneren aangetast kan zijn door neuropathie geassocieerd met excessief gebruik.
    - Recent gebruik van sederende, stimulerende of dissociërende geneesmiddelen. Dit wordt nagegaan d.m.v. bevraging en eventueel opvragen patiënten dossier bij huisarts.
    - Recent gebruik van andere vaak voorkomende roesopwekkende middelen bepaald d.m.v. een urinetest bij aanvang van de training en testdagen (Surestep™ urine drugscreen casette voor amphetamines, benzodiazepinen, cocaïne, metamphetamines, morfine, THC)
    - Recent gebruik van alcohol zoals bepaald door een positieve ademtest.
    - Overmatig gebruik van alcohol (≥21 standaard glazen per week voor mannen of ≥14 standaard glazen per week voor vrouwen)
    - Zwangerschap (bepaald door Alere™ urine hCG test bij aanvang eerste testdag) en/of geen gebruik van contraceptie voor vrouwen in de mogelijkheid om zwanger te worden
    - Latex allergie.
    E.5 End points
    E.5.1Primary end point(s)
    - Tracking error in mm during divided attention task (DAT)
    - Reaction times after appearance of target stimuli during divided attention task (DAT)
    - Tracking error in mm tijdens divided attention task (DAT)
    - Reactie tijden na verschijnen van target stimuli tijdens divided attention task (DAT)
    E.5.1.1Timepoint(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)
    Tijdstip 1: begin van de beoordeling binnen 5 minuten na toediening (duur 12 minuten)
    Tijdstip 2: begin van de beoordeling binnen 25 minuten na toediening (duur 12 minuten)
    Tijdstip 3: start van de beoordeling binnen 45 minuten na toediening (duur 12 minuten)
    E.5.2Secondary 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
    - Aantal correcte antwoorden tijdens digit-symbol substitution test (DSST)
    - Benodigde tijd voor afronden trailmaking test (TMT)
    - Intensiteit of toepasselijkheid van subjectieve ervaringen in mm zoals aangegeven op verschillende visuele analoge schalen (VAS)
    - N2O concentratie in uitgeademde lucht
    E.5.2.1Timepoint(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
    - 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- VAS: -4min, +15min, +35min, +55mint, +75 minuten na toediening lachgas
    - N20 concentraties in uitgeademde lucht: -20minuten, -8minuten, +1minuut, +13minuten, +21minuten, +33minuten, +41minuten, +53minuten, +71minuten ten opzichte van toediening lachgas
    E.6 and E.7 Scope of the trial
    E.6Scope of the trial
    E.6.1Diagnosis No
    E.6.2Prophylaxis No
    E.6.3Therapy No
    E.6.4Safety No
    E.6.5Efficacy No
    E.6.6Pharmacokinetic Yes
    E.6.7Pharmacodynamic Yes
    E.6.8Bioequivalence No
    E.6.9Dose response Yes
    E.6.10Pharmacogenetic No
    E.6.11Pharmacogenomic No
    E.6.12Pharmacoeconomic No
    E.6.13Others Yes
    E.6.13.1Other scope of the trial description
    To determine the duration of impaired psychomotor functioning after acute intoxication with nitrous oxide resulting from recreational use
    Bepalen van de duur van de verstoorde psychomotorische werking na acute intoxicatie met distikstofmonoxide als gevolg van recreatief gebruik
    E.7Trial type and phase
    E.7.1Human pharmacology (Phase I) No
    E.7.1.1First administration to humans No
    E.7.1.2Bioequivalence study No
    E.7.1.3Other No
    E.7.1.3.1Other trial type description
    E.7.2Therapeutic exploratory (Phase II) No
    E.7.3Therapeutic confirmatory (Phase III) No
    E.7.4Therapeutic use (Phase IV) Yes
    E.8 Design of the trial
    E.8.1Controlled Yes
    E.8.1.1Randomised Yes
    E.8.1.2Open No
    E.8.1.3Single blind No
    E.8.1.4Double blind Yes
    E.8.1.5Parallel group No
    E.8.1.6Cross over Yes
    E.8.1.7Other No
    E.8.2 Comparator of controlled trial
    E.8.2.1Other medicinal product(s) No
    E.8.2.2Placebo Yes
    E.8.2.3Other No
    E.8.2.4Number of treatment arms in the trial6
    E.8.3 The trial involves single site in the Member State concerned No
    E.8.4 The trial involves multiple sites in the Member State concerned Yes
    E.8.4.1Number of sites anticipated in Member State concerned2
    E.8.5The trial involves multiple Member States No
    E.8.6 Trial involving sites outside the EEA
    E.8.6.1Trial being conducted both within and outside the EEA No
    E.8.6.2Trial being conducted completely outside of the EEA No
    E.8.7Trial has a data monitoring committee No
    E.8.8 Definition of the end of the trial and justification where it is not the last visit of the last subject undergoing the trial
    Last visit of the last participant undergoing the trial or decision by competent authority on the bases of reported AE, SAE or SUSAR
    Laatste bezoek van de laatste deelnemer aan de proef of besluit van de bevoegde instantie op grond van gerapporteerde AE, SAE of SUSAR
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years0
    E.8.9.1In the Member State concerned months7
    E.8.9.1In the Member State concerned days0
    F. Population of Trial Subjects
    F.1 Age Range
    F.1.1Trial has subjects under 18 No
    F.1.1.1In Utero No
    F.1.1.2Preterm newborn infants (up to gestational age < 37 weeks) No
    F.1.1.3Newborns (0-27 days) No
    F.1.1.4Infants and toddlers (28 days-23 months) No
    F.1.1.5Children (2-11years) No
    F.1.1.6Adolescents (12-17 years) No
    F.1.2Adults (18-64 years) Yes
    F.1.2.1Number of subjects for this age range: 36
    F.1.3Elderly (>=65 years) No
    F.2 Gender
    F.2.1Female Yes
    F.2.2Male Yes
    F.3 Group of trial subjects
    F.3.1Healthy volunteers Yes
    F.3.2Patients No
    F.3.3Specific vulnerable populations Yes
    F.3.3.1Women of childbearing potential not using contraception No
    F.3.3.2Women of child-bearing potential using contraception Yes
    F.3.3.3Pregnant women No
    F.3.3.4Nursing women No
    F.3.3.5Emergency situation No
    F.3.3.6Subjects incapable of giving consent personally No
    F.3.3.7Others No
    F.4 Planned number of subjects to be included
    F.4.1In the member state36
    F.5 Plans for treatment or care after the subject has ended the participation in the trial (if it is different from the expected normal treatment of that condition)
    None apart from follow up of any potentia reported adverse events
    Geen anders dan opvolging van gemelde adverse events
    G. Investigator Networks to be involved in the Trial
    N. Review by the Competent Authority or Ethics Committee in the country concerned
    N.Competent Authority Decision Authorised
    N.Date of Competent Authority Decision2023-03-09
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2022-01-21
    P. End of Trial
    P.End of Trial StatusOngoing
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