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Die Auswirkungen von Cannabidiol auf die Fahrleistung gesunder Erwachsener nach Dosis und Geschlecht

5. Oktober 2026 aktualisiert von: Toni Marie Rudisill, West Virginia University

The objectives/purpose of this study are to comprehensively investigate the effects of non-prescription CBD on driving performance, drowsiness, sedation, and cognitive function in a large sample of healthy adults aged 18-30 years, with additional characterization of effects by dose and by sex, using a rigorous RCT design which will naturally mitigate confounding factors.

Studienübersicht

Status

Rekrutierung

Bedingungen

Intervention / Behandlung

Studientyp

Interventionell

Einschreibung (Geschätzt)

300

Phase

  • Phase 1

Kontakte und Standorte

Dieser Abschnitt enthält die Kontaktdaten derjenigen, die die Studie durchführen, und Informationen darüber, wo diese Studie durchgeführt wird.

Studienkontakt

Studienorte

    • West Virginia
      • Morgantown, West Virginia, Vereinigte Staaten, 26506
        • Rekrutierung
        • West Virginia University
        • Kontakt:
        • Hauptermittler:
          • Toni M Rudisill, PhD

Teilnahmekriterien

Forscher suchen nach Personen, die einer bestimmten Beschreibung entsprechen, die als Auswahlkriterien bezeichnet werden. Einige Beispiele für diese Kriterien sind der allgemeine Gesundheitszustand einer Person oder frühere Behandlungen.

Zulassungskriterien

Studienberechtigtes Alter

18 Jahre bis 30 Jahre (Erwachsene)

Akzeptiert gesunde Freiwillige

Ja

Studienberechtigte Geschlechter

Alle

Beschreibung

Inclusion Criteria:

  • Possess a current drivers' license
  • Driven a motor vehicle at least once in the past 30 days
  • Able to read English
  • Test negative for all substances on a urine drug test and complete a test drive to ensure the absence of simulation sickness
  • Not taking any daily prescription medications (excluding birth control)
  • Not diagnosed with any serious chronic disease by a licensed healthcare provider (including but not limited to Alzheimer's and related dementias, Parkinson's disease or other neurodegenerative disorder, major depressive or anxiety disorder, schizophrenia or other serious mental illness, arrhythmias, cataracts, glaucoma, chronic obstructive pulmonary disease, diabetes, epilepsy, sleep apnea, and fibromyalgia)
  • Have an individual willing to drive them home after testing or be taken home by study staff after testing

Exclusion Criteria:

  • Currently smoke, vape or use tobacco products, used CBD in the past 30 days
  • Used illegal drugs in the past 30 days (e.g., cocaine/crack, heroin, methamphetamine, 3,4-methylenedioxy-methamphetamine, inhalants, phencyclidine, lysergic acid diethylamide, psilocybin mushrooms, or marijuana)
  • Are pregnant or lactating at time of study

Studienplan

Dieser Abschnitt enthält Einzelheiten zum Studienplan, einschließlich des Studiendesigns und der Messung der Studieninhalte.

Wie ist die Studie aufgebaut?

Designdetails

  • Hauptzweck: Grundlegende Wissenschaft
  • Zuteilung: Zufällig
  • Interventionsmodell: Parallele Zuordnung
  • Maskierung: Verdreifachen

Waffen und Interventionen

Teilnehmergruppe / Arm
Intervention / Behandlung
Aktiver Komparator: Cannabidiol (CBD) Oil 300mg

Cannabidiol (CBD) Oil, 300mg, 1 dose, 120 minutes prior to testing. After consumption of the respective treatment drug, the participant will be given a standardized meal and wait for 120 minutes to allow for drug absorption and for CBD to begin taking effect; this time frame was chosen based on the pharmacokinetics of CBD along with the consideration of participant burden (max absorption 2-5 hours; average half-life 17 hours).

Cannabidiol (CBD) Oil 300mg, 1 dose

Aktiver Komparator: Cannabidiol (CBD) Oil 150mg

Cannabidiol (CBD) Oil, 150mg, 1 dose, 120 minutes prior to testing. After consumption of the respective treatment drug, the participant will be given a standardized meal and wait for 120 minutes to allow for drug absorption and for CBD to begin taking effect; this time frame was chosen based on the pharmacokinetics of CBD along with the consideration of participant burden (max absorption 2-5 hours; average half-life 17 hours).

Cannabidiol (CBD) Oil 150mg, 1 dose

Placebo-Komparator: Placebo Oil

Placebo Oil 1 dose 120 minutes prior to testing. After consumption of the respective treatment drug/placebo, the participant will be given a standardized meal and wait for 120 minutes to allow for drug absorption and for CBD to begin taking effect; this time frame was chosen based on the pharmacokinetics of CBD along with the consideration of participant burden (max absorption 2-5 hours; average half-life 17 hours).

Placebo Oil, 1 dose

Was misst die Studie?

Primäre Ergebnismessungen

Ergebnis Maßnahme
Maßnahmenbeschreibung
Zeitfenster
Mean standard deviation of lateral position
Zeitfenster: 150 minutes post intervention

The driving simulator will measure mean standard deviation which is the amount a driver is weaving within the lane during the drive. Ranges from 0 to infinity, with higher means indicating worse performance.

150 minutes post intervention
Number of collisions
Zeitfenster: 150 minutes post intervention

The driving simulator will measure how many times a participant crashes into other vehicles, signs, pedestrians, etc. during the simulation. Ranges from 0 to infinity, with higher numbers indicating worse performance.

150 minutes post intervention
Mean reaction time to stimuli
Zeitfenster: 150 minutes post intervention

The driving simulator will measure the mean reaction time (seconds) that it takes for a person to brake when exposed to stimuli. Ranges from 0 to infinity, with higher means indicating worse performance.

150 minutes post intervention
Percent of time driver is out of travel lane
Zeitfenster: 150 minutes post intervention

The driving simulator will measure the percent of time that each driver spends driving outside their travel lane. Percent ranges from 0-100, with higher scores indicating worse performance.

150 minutes post intervention

Sekundäre Ergebnismessungen

Ergebnis Maßnahme
Maßnahmenbeschreibung
Zeitfenster
Self-reported sleepiness scale
Zeitfenster: baseline

Sleepiness will be assessed via the Stanford Sleepiness Scale which is a one question Likert scale question that ask a person's sleepiness level at that moment in time. The scale ranges from 1-7 with higher scores indicating more sleepiness. This test will be administered on a laptop.

baseline
Self-reported sleepiness scale
Zeitfenster: 200 minutes post intervention

Sleepiness will be assessed via the Stanford Sleepiness Scale which is a one question Likert scale question that ask a person's sleepiness level at that moment in time. The scale ranges from 1-7 with higher scores indicating more sleepiness. This test will be administered on a laptop.

200 minutes post intervention
Mental sedation score
Zeitfenster: baseline

The Visual Analog Mood Scale is a 16 question Likert type scale that assess different facets of a person's mental state. Questions 1,4,11, and 13 are summed together to get a mental sedation score. Higher scores indicate more sedation. This ranges from 0-400.This test will be administered on a laptop.

baseline
Mental sedation score
Zeitfenster: 200 minutes post intervention

The Visual Analog Mood Scale is a 16 question Likert type scale that assess different facets of a person's mental state. Questions 1,4,11, and 13 are summed together to get a mental sedation score. Higher scores indicate more sedation. This ranges from 0-400.This test will be administered on a laptop.

200 minutes post intervention
Physical sedation score
Zeitfenster: baseline

The Visual Analog Mood Scale is a 16 question Likert type scale that assess different facets of a person's mental state. Questions 3,5,6, and 16 are summed together to get a physical sedation score. Higher scores indicate more physical sedation. This ranges from 0-400. This test will be administered on a laptop.

baseline
Physical sedation score
Zeitfenster: 200 minutes post intervention

The Visual Analog Mood Scale is a 16 question Likert type scale that assess different facets of a person's mental state. Questions 3,5,6, and 16 are summed together to get a physical sedation score. Higher scores indicate more physical sedation. This ranges from 0-400. This test will be administered on a laptop.

200 minutes post intervention
Mean reaction time to stimuli for PVT
Zeitfenster: baseline

The psychomotor vigilance test is given via a computer program and assesses different facets of a person's vigilance, or ability to pay attention. It will measure a participants mean reaction time to the stimuli presented (in milliseconds). Higher times indicate worse performance. This ranges from 0 to infinity.

baseline
Mean reaction time to stimuli for PVT
Zeitfenster: 200 minutes post intervention

The psychomotor vigilance test is given via a computer program and assesses different facets of a person's vigilance, or ability to pay attention. It will measure a participants mean reaction time to the stimuli presented (in milliseconds). Higher times indicate worse performance. This ranges from 0 to infinity.

200 minutes post intervention
Number of lapses in attention for PVT
Zeitfenster: Baseline

The psychomotor vigilance test is given via a computer program and assesses different facets of a person's vigilance, or ability to pay attention. It will measure a participants number of lapses in attention to presented stimuli. The test considers any reaction over 500 milliseconds to be a lapse in attention. More lapses indicate worse performance. This ranges from 0 to infinity.

Baseline
Number of lapses in attention for PVT
Zeitfenster: 200 minutes post intervention

The psychomotor vigilance test is given via a computer program and assesses different facets of a person's vigilance, or ability to pay attention. It will measure a participants number of lapses in attention to presented stimuli. The test considers any reaction over 500 milliseconds to be a lapse in attention. More lapses indicate worse performance. This ranges from 0 to infinity.

200 minutes post intervention
Mean lapse duration for PVT
Zeitfenster: Baseline

The psychomotor vigilance test is given via a computer program and assesses different facets of a person's vigilance, or ability to pay attention. It will measure a participants number of lapses in attention to presented stimuli. The test considers any reaction over 500 milliseconds to be a lapse in attention. It measures the mean lapse duration for each participant. Longer lapses indicate worse performance. This ranges from 0 to infinity.

Baseline
Mean lapse duration for PVT
Zeitfenster: 200 minutes post intervention

The psychomotor vigilance test is given via a computer program and assesses different facets of a person's vigilance, or ability to pay attention. It will measure a participants number of lapses in attention to presented stimuli. The test considers any reaction over 500 milliseconds to be a lapse in attention. It measures the mean lapse duration for each participant. Longer lapses indicate worse performance. This ranges from 0 to infinity.

200 minutes post intervention
Number of errors for PVT
Zeitfenster: Baseline

The psychomotor vigilance test is given via a computer program and assesses different facets of a person's vigilance, or ability to pay attention. It will measure how many errors a person makes during the 10-minute test. More errors indicate worse performance. This ranges from 0 to infinity.

Baseline
Number of errors for PVT
Zeitfenster: 200 minutes post intervention

The psychomotor vigilance test is given via a computer program and assesses different facets of a person's vigilance, or ability to pay attention. It will measure how many errors a person makes during the 10-minute test. More errors indicate worse performance. This ranges from 0 to infinity.

200 minutes post intervention
Interference score for mean reaction on FT
Zeitfenster: Baseline

The Flanker Task is administered on a laptop. The test assesses the mean reaction time to congruent and incongruent scenarios presented to participants. The score is the difference when subtracting the mean reaction time for congruent scenarios from the mean reaction time for incongruent scenarios. Larger differences indicate more impairment.

Baseline
Interference score for mean reaction on FT
Zeitfenster: 200 minutes post intervention

The Flanker Task is administered on a laptop. The test assesses the mean reaction time to congruent and incongruent scenarios presented to participants. The score is the difference when subtracting the mean reaction time for congruent scenarios from the mean reaction time for incongruent scenarios. Larger differences indicate more impairment.

200 minutes post intervention
Interference score for accuracy on FT
Zeitfenster: Baseline

The Flanker Task is administered on a laptop. The test assesses the mean accuracy to congruent and incongruent scenarios presented to participants. The score is the difference when subtracting the mean accuracy for congruent scenarios from the mean accuracy for incongruent scenarios. Larger differences indicate more impairment.

Baseline
Interference score for accuracy on FT
Zeitfenster: 200 minutes post intervention

The Flanker Task is administered on a laptop. The test assesses the mean accuracy to congruent and incongruent scenarios presented to participants. The score is the difference when subtracting the mean accuracy for congruent scenarios from the mean accuracy for incongruent scenarios. Larger differences indicate more impairment.

200 minutes post intervention
Time to accurately complete the Trail Making Test Part A
Zeitfenster: Baseline

Trail Making Test A provides an assessment of complex attention. This test is typically ended after 5 minutes. Thus, possible outcomes are 1-300 seconds. Greater time indicates more impairment.

Baseline
Time to accurately complete the Trail Making Test Part A
Zeitfenster: 200 minutes post intervention

Trail Making Test A provides an assessment of complex attention. This test is typically ended after 5 minutes. Thus, possible outcomes are 1-300 seconds. Greater time indicates more impairment.

200 minutes post intervention
Time to accurately complete the Trail Making Test Part B
Zeitfenster: Baseline

TMT Part B is a neuropsychological test that assesses a person's ability to switch cognitive sets and process information. This test is typically ended after This test is typically ended after 5 minutes. thus, possible outcomes are 1-300 seconds. Greater time indicates more impairment.

Baseline
Time to accurately complete the Trail Making Test Part B
Zeitfenster: 200 minutes post intervention

TMT Part B is a neuropsychological test that assesses a person's ability to switch cognitive sets and process information. This test is typically ended after This test is typically ended after 5 minutes. thus, possible outcomes are 1-300 seconds. Greater time indicates more impairment.

200 minutes post intervention
Total recalled words on the Hopkins Verbal Learning test
Zeitfenster: Baseline

The Hopkins Verbal Learning test assesses an individual's ability to learn a list of 12 words over 3 different learning trials. Ranges from 0 to infinity. Greater numbers of recalled words mean better performance.

Baseline
Total recalled words on the Hopkins Verbal Learning test
Zeitfenster: 200 minutes post intervention

The Hopkins Verbal Learning test assesses an individual's ability to learn a list of 12 words over 3 different learning trials. Ranges from 0 to infinity. Greater numbers of recalled words mean better performance.

200 minutes post intervention
Discrimination index for the Hopkins Verbal Learning test
Zeitfenster: Baseline

The Hopkins Verbal Learning test assesses an individual's ability to learn a list of 12 words over 3 different learning trials. Ranges from 0 to infinity. The discrimination index is calculated by taking the number of hits minus the number of false positives. Higher values indicate better performance.

Baseline
Discrimination index for the Hopkins Verbal Learning test
Zeitfenster: 200 minutes post intervention

The Hopkins Verbal Learning test assesses an individual's ability to learn a list of 12 words over 3 different learning trials. Ranges from 0 to infinity. The discrimination index is calculated by taking the number of hits minus the number of false positives. Higher values indicate better performance.

200 minutes post intervention
Percentage correctness of response on Stroop Test
Zeitfenster: Baseline

The Stroop Test is a neuropsychological test extensively used to assess the ability to inhibit cognitive interference that occurs when the processing of a specific stimulus feature impedes the simultaneous processing of a second stimulus attribute. Ranges from 0-100%. The higher the percentage, the more accurate.

Baseline
Percentage correctness of response on Stroop Test
Zeitfenster: 200 minutes post intervention

The Stroop Test is a neuropsychological test extensively used to assess the ability to inhibit cognitive interference that occurs when the processing of a specific stimulus feature impedes the simultaneous processing of a second stimulus attribute. Ranges from 0-100%. The higher the percentage, the more accurate.

200 minutes post intervention
Number congruent responses on Stroop Test
Zeitfenster: Baseline

The Stroop Test is a neuropsychological test extensively used to assess the ability to inhibit cognitive interference that occurs when the processing of a specific stimulus feature impedes the simultaneous processing of a second stimulus attribute. Ranges from 0-infinity. Higher numbers indicate better performance.

Baseline
Number congruent responses on Stroop Test
Zeitfenster: 200 minutes post intervention

The Stroop Test is a neuropsychological test extensively used to assess the ability to inhibit cognitive interference that occurs when the processing of a specific stimulus feature impedes the simultaneous processing of a second stimulus attribute. Ranges from 0-infinity. Higher numbers indicate better performance.

200 minutes post intervention
Number incongruent responses on Stroop Test
Zeitfenster: Baseline

The Stroop Test is a neuropsychological test extensively used to assess the ability to inhibit cognitive interference that occurs when the processing of a specific stimulus feature impedes the simultaneous processing of a second stimulus attribute. Ranges from 0-infinity. Higher numbers indicate worse performance

Baseline
Number incongruent responses on Stroop Test
Zeitfenster: 200 minutes post intervention

The Stroop Test is a neuropsychological test extensively used to assess the ability to inhibit cognitive interference that occurs when the processing of a specific stimulus feature impedes the simultaneous processing of a second stimulus attribute. Ranges from 0-infinity. Higher numbers indicate worse performance

200 minutes post intervention
Sum of scores for forward and backward responses on Digit Span test
Zeitfenster: Baseline

The digit span test is a very short test that evaluates a person's cognitive status. It is frequently used in hospitals and physicians' offices in order for a clinician to quickly evaluate whether a person's cognitive abilities are normal or impaired. Ranges from 0 to infinity. Participant receives a score if they recall a numbered sequence in the forward and backward direction. If the sequence is correct, a point is earned. Higher scores indicate better performance.

Baseline
Sum of scores for forward and backward responses on Digit Span test
Zeitfenster: 200 minutes post intervention

The digit span test is a very short test that evaluates a person's cognitive status. It is frequently used in hospitals and physicians' offices in order for a clinician to quickly evaluate whether a person's cognitive abilities are normal or impaired. Ranges from 0 to infinity. Participant receives a score if they recall a numbered sequence in the forward and backward direction. If the sequence is correct, a point is earned. Higher scores indicate better performance.

200 minutes post intervention
Gestalt score based on correctness of clock drawing
Zeitfenster: Baseline

The Clock Drawing Test (CDT) is a screening tool for cognitive impairment. Score ranges from 0-5. Higher scores indicate an accurate drawing.

Baseline
Gestalt score based on correctness of clock drawing
Zeitfenster: 200 minutes post intervention

The Clock Drawing Test (CDT) is a screening tool for cognitive impairment. Score ranges from 0-5. Higher scores indicate an accurate drawing.

200 minutes post intervention
Number of correct and non-duplicate responses on Animal Naming test
Zeitfenster: Baseline

Animal Naming Test is a semantic fluency test that consists of listing as many names of animals as possible in 1 minute. Ranges from 0-infinity. The higher the number, the better the performance.

Baseline
Number of correct and non-duplicate responses on Animal Naming test
Zeitfenster: 200 minutes post intervention

Animal Naming Test is a semantic fluency test that consists of listing as many names of animals as possible in 1 minute. Ranges from 0-infinity. The higher the number, the better the performance.

200 minutes post intervention
Number of omission errors on N-back test
Zeitfenster: Baseline

Ranges from 0-infinity. More errors indicate worse performance

Baseline
Number of omission errors on N-back test
Zeitfenster: 200 minutes post intervention

The n-back task is a continuous performance task that is commonly used as an assessment in psychology and cognitive neuroscience to measure a part of working memory and working memory capacity. The subject is presented with a sequence of stimuli, and the task consists of indicating when the current stimulus matches the one from n steps earlier in the sequence. Ranges from 0-infinity. More errors indicate worse performance

200 minutes post intervention
Number of commission errors on N-Back test
Zeitfenster: Baseline

The n-back task is a continuous performance task that is commonly used as an assessment in psychology and cognitive neuroscience to measure a part of working memory and working memory capacity. The subject is presented with a sequence of stimuli, and the task consists of indicating when the current stimulus matches the one from n steps earlier in the sequence. Ranges from 0-infinity. More errors indicate worse performance

Baseline
Number of commission errors on N-Back test
Zeitfenster: 200 minutes post intervention

The n-back task is a continuous performance task that is commonly used as an assessment in psychology and cognitive neuroscience to measure a part of working memory and working memory capacity. The subject is presented with a sequence of stimuli, and the task consists of indicating when the current stimulus matches the one from n steps earlier in the sequence. Ranges from 0-infinity. More errors indicate worse performance

200 minutes post intervention
Percent correct matches on N-Back test
Zeitfenster: Baseline

The n-back task is a continuous performance task that is commonly used as an assessment in psychology and cognitive neuroscience to measure a part of working memory and working memory capacity. The subject is presented with a sequence of stimuli, and the task consists of indicating when the current stimulus matches the one from n steps earlier in the sequence. Ranges from 0-100%. Higher percent correct is better performance

Baseline
Percent correct matches on N-Back test
Zeitfenster: 200 minutes post intervention

The n-back task is a continuous performance task that is commonly used as an assessment in psychology and cognitive neuroscience to measure a part of working memory and working memory capacity. The subject is presented with a sequence of stimuli, and the task consists of indicating when the current stimulus matches the one from n steps earlier in the sequence. Ranges from 0-100%. Higher percent correct is better performance

200 minutes post intervention

Mitarbeiter und Ermittler

Hier finden Sie Personen und Organisationen, die an dieser Studie beteiligt sind.

Sponsor

Mitarbeiter

Ermittler

  • Hauptermittler: Toni M Rudisill, PhD, West Virginia University

Studienaufzeichnungsdaten

Diese Daten verfolgen den Fortschritt der Übermittlung von Studienaufzeichnungen und zusammenfassenden Ergebnissen an ClinicalTrials.gov. Studienaufzeichnungen und gemeldete Ergebnisse werden von der National Library of Medicine (NLM) überprüft, um sicherzustellen, dass sie bestimmten Qualitätskontrollstandards entsprechen, bevor sie auf der öffentlichen Website veröffentlicht werden.

Haupttermine studieren

Studienbeginn (Tatsächlich)

30. Juni 2025

Primärer Abschluss (Geschätzt)

31. Dezember 2028

Studienabschluss (Geschätzt)

1. Mai 2029

Studienanmeldedaten

Zuerst eingereicht

11. November 2024

Zuerst eingereicht, das die QC-Kriterien erfüllt hat

11. November 2024

Zuerst gepostet (Tatsächlich)

13. November 2024

Studienaufzeichnungsaktualisierungen

Letztes Update gepostet (Tatsächlich)

6. Oktober 2026

Letztes eingereichtes Update, das die QC-Kriterien erfüllt

5. Oktober 2026

Zuletzt verifiziert

1. Oktober 2026

Mehr Informationen

Begriffe im Zusammenhang mit dieser Studie

Andere Studien-ID-Nummern

  • 2311874160
  • 1R01DA058678-01A1 (US NIH Stipendium/Vertrag)

Arzneimittel- und Geräteinformationen, Studienunterlagen

Studiert ein von der US-amerikanischen FDA reguliertes Arzneimittelprodukt

Ja

Studiert ein von der US-amerikanischen FDA reguliertes Geräteprodukt

Nein

Produkt, das in den USA hergestellt und aus den USA exportiert wird

Nein

Diese Informationen wurden ohne Änderungen direkt von der Website clinicaltrials.gov abgerufen. Wenn Sie Ihre Studiendaten ändern, entfernen oder aktualisieren möchten, wenden Sie sich bitte an register@clinicaltrials.gov. Sobald eine Änderung auf clinicaltrials.gov implementiert wird, wird diese automatisch auch auf unserer Website aktualisiert .