Effekten av oral cannabisadministrasjon og samadministrasjon av alkohol på svekkelse
29. juli 2026 oppdatert av: Johns Hopkins University
Denne studien vil evaluere de individuelle og interaktive effektene av oral cannabis og alkohol på subjektive og atferdsmessige mål på svekkelse.
Studieoversikt
Status
Fullført
Forhold
Intervensjon / Behandling
Detaljert beskrivelse
Denne kliniske laboratoriestudien vil være dobbeltblind, placebokontrollert og vil bruke et eksperimentelt design innen fag.
Deltakerne vil gjennomføre 7 polikliniske legemiddeladministrasjonsøkter som vil bestå av selvadministrering av oral cannabis (0, 10 eller 25 mg THC) og alkohol (enten placebo eller aktiv; BAC på 0,05 prosent); deltakerne vil alltid få både en alkoholdrikk (aktiv eller placebo) og dose cannabis (aktiv eller placebo).
Deltakerne vil også fullføre en tilstand der de administrerer alkohol (BAC: 0,08 prosent) med placebo cannabis, som en positiv kontroll.
Primære resultater inkluderer ytelse på feltedruelighetstester, kognitiv og psykomotorisk svekkelse, subjektive medikamenteffekter og simulert kjøreprestasjon.
Blodkonsentrasjoner av THC og THC-metabolitter vil også bli bestemt.
Studietype
Intervensjonell
Registrering (Faktiske)
70
Fase
- Fase 1
Kontakter og plasseringer
Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.
Studiesteder
-
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Maryland
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Baltimore, Maryland, Forente stater, 21224
- Johns Hopkins Behavioral Pharmacology Research Unit
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Deltakelseskriterier
Forskere ser etter personer som passer til en bestemt beskrivelse, kalt kvalifikasjonskriterier. Noen eksempler på disse kriteriene er en persons generelle helsetilstand eller tidligere behandlinger.
Kvalifikasjonskriterier
Alder som er kvalifisert for studier
21 år til 55 år (Voksen)
Tar imot friske frivillige
Ja
Beskrivelse
Inklusjonskriterier:
- Har gitt skriftlig informert samtykke
- Være mellom 21 og 50 år
- Være i god generell helse basert på en fysisk undersøkelse, sykehistorie, vitale tegn og screening av urin- og blodprøver
- Ikke være gravid eller ammende (hvis kvinne). Alle kvinner må ha en negativ serumgraviditetstest ved screeningbesøket og en negativ uringraviditetstest ved hvert studiebesøk.
- Ha en kroppsmasseindeks (BMI) i området 19 til 36 kg/m2
- Blodtrykket ved screeningbesøk overstiger ikke et systolisk blodtrykk (SBP) på 150 mmHg eller et diastolisk blodtrykk (DBP) på 90 mmHg
- Har ikke donert blod de siste 30 dagene.
- Rapporter minst 2 dager med overstadig drikking de siste 90 dagene (mer enn 4 eller 5 drinker ved en enkelt anledning for henholdsvis kvinner og menn)
- Rapporter ≥ 5 bruk av cannabis det siste året
- Gi negativ urinprøve for bruk av ulovlige stoffer (unntatt THC) og negativ alkoholtest (0 % BAC) ved screening og før studieøkter
- Rapporter minst 1 forekomst av samtidig alkohol og bruk det siste året.
Ekskluderingskriterier:
- Psykoaktiv narkotikabruk (bortsett fra cannabis, nikotin, alkohol eller koffein) den siste måneden
- Gjeldende bruk av reseptfrie (OTC) legemidler, kosttilskudd/vitaminer eller reseptbelagte medisiner som, etter etterforskerens eller medisinsk personells oppfatning, vil påvirke deltakerens sikkerhet
- Historie eller nåværende bevis på betydelig medisinsk tilstand
- Bevis på nåværende psykiatrisk tilstand [(MINI for Diagnostic and Statistical Manual (DSM)-V)]
- Oppfyll kriteriene for alvorlig alkoholbruksforstyrrelse (MINI for DSM-V)
- Clinical Institute Abstinensvurdering for alkoholskala (CIWA-Ar) score > 9
- Har vært i behandling tidligere for alkohol- eller cannabisbruksforstyrrelser
- Bruk av cannabis i gjennomsnitt mer enn 2 ganger i uken de siste 3 månedene
- Leverfunksjonstester mer enn 2x normalområdet
- Registrering i en annen klinisk utprøving eller mottak av et medikament som en del av forskning innen de siste 30 dagene
- Shipley vokabularscore <18 (tilsvarer lesenivå på 5. klasse).
Studieplan
Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.
Hvordan er studiet utformet?
Designdetaljer
- Primært formål: Grunnvitenskap
- Tildeling: Randomisert
- Intervensjonsmodell: Crossover-oppdrag
- Masking: Dobbelt
Våpen og intervensjoner
Deltakergruppe / Arm |
Intervensjon / Behandling |
|---|---|
|
Placebo komparator: Placebo cannabis + placebo alkohol
Deltakerne administrerer oral cannabis som inneholder 0 mg THC i kombinasjon med en placebo alkoholdrikk.
|
Cannabis vil bli oralt inntatt via en brownie
Alkohol vil bli oralt inntatt via en smaksatt drink
|
|
Eksperimentell: lavdose cannabis med placebo alkohol
Deltakerne administrerer oral cannabis som inneholder 10 mg THC i kombinasjon med en placebo alkoholdrikk.
|
Cannabis vil bli oralt inntatt via en brownie
Alkohol vil bli oralt inntatt via en smaksatt drink
|
|
Eksperimentell: høy dose cannabis med placebo alkohol
Deltakerne administrerer oral cannabis som inneholder 25 mg THC i kombinasjon med en placebo alkoholdrikk.
|
Cannabis vil bli oralt inntatt via en brownie
Alkohol vil bli oralt inntatt via en smaksatt drink
|
|
Eksperimentell: lavdose cannabis med lavdose alkohol
Deltakerne administrerer oral cannabis som inneholder 10 mg THC i kombinasjon med en alkoholdrikk (0,05 prosent BAC).
|
Cannabis vil bli oralt inntatt via en brownie
Alkohol vil bli oralt inntatt via en smaksatt drink
|
|
Eksperimentell: høy dose cannabis med lav dose alkohol
Deltakerne administrerer oral cannabis som inneholder 25 mg THC i kombinasjon med en alkoholdrikk (0,05 prosent BAC).
|
Cannabis vil bli oralt inntatt via en brownie
Alkohol vil bli oralt inntatt via en smaksatt drink
|
|
Eksperimentell: Placebo cannabis + lavdose alkohol
Deltakerne administrerer oral cannabis som inneholder 0 mg THC i kombinasjon med en alkoholdrikk (0,05 prosent BAC).
|
Cannabis vil bli oralt inntatt via en brownie
Alkohol vil bli oralt inntatt via en smaksatt drink
|
|
Eksperimentell: Placebo cannabis + høydose alkohol
Deltakerne administrerer oral cannabis som inneholder 0 mg THC i kombinasjon med en alkoholdrikk (0,08 prosent BAC).
|
Cannabis vil bli oralt inntatt via en brownie
Alkohol vil bli oralt inntatt via en smaksatt drink
|
Hva måler studien?
Primære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
|
Mean Peak Change From Baseline DRUID Application Global Impairment Score
Tidsramme: 7.5 hours, assessed at baseline (prior to drug administration) and again 1, 1.5, 2.5, 3.5, 4.5, 5.5, 6.5, and 7.5 hours after oral cannabis ingestion.
|
Acute cognitive and behavioral impairment will be assessed with global impairment score (range 0-100) on the DRUID app (higher scores indicate greater impairment).
Results are mean change from baseline.
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7.5 hours, assessed at baseline (prior to drug administration) and again 1, 1.5, 2.5, 3.5, 4.5, 5.5, 6.5, and 7.5 hours after oral cannabis ingestion.
|
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Cumulative Score on Field Sobriety Tests
Tidsramme: 7.5 hours
|
Impairment will be assessed using a battery of standard field sobriety tests including: the Horizontal Gaze Nystagmus Test (HGN), the Walk and Turn, the One Leg Stand, and the Modified Romberg Balance.
We will report the cumulative amount of clues observed across these tasks (out of a possible 0-22 clues).
Higher scores indicate greater/worse impairment.
These assessments were completed once after 7.5 hours.
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7.5 hours
|
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Mean Peak Change From Baseline Scores on the Drug Effect Questionnaire (DEQ) - Feel Drug Effect
Tidsramme: 7.5 hours, assessed at baseline (prior to drug administration) and again 0.5, 1, 1.25, 1.5, 2.5, 3.5, 4.5, 5.5, 6.5, and 7.5 hours after oral cannabis ingestion
|
The DEQ will be used to obtain subjective ratings of "feel drug effects".
Score range from 0 (none) to 100 (extreme) using a 100mm line anchored with none/extreme designation.
Results are mean change from baseline and a higher score indicates a more extreme/worse drug effect.
|
7.5 hours, assessed at baseline (prior to drug administration) and again 0.5, 1, 1.25, 1.5, 2.5, 3.5, 4.5, 5.5, 6.5, and 7.5 hours after oral cannabis ingestion
|
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Drug Effect Questionnaire - Feel High
Tidsramme: 7.5 hours
|
The DEQ will be used to obtain subjective ratings of "feel high".
Score range from 0 (none) to 100 (extreme) using a 100mm line anchored with none/extreme designation.
Higher score greater "feel high" rating.
|
7.5 hours
|
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Drug Effect Questionnaire - Confidence to Drive (Change From Baseline)
Tidsramme: 7.5 hours
|
The DEQ will be used to obtain subjective ratings of "confidence to drive".
Score range from 0 (none) to 100 (extreme) using a 100mm line anchored with none/extreme designation.
Higher scores indicate higher confidence to drive.
Results expressed as change from baseline
|
7.5 hours
|
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Drug Effect Questionnaire - Willingness to Drive
Tidsramme: 7.5 hours
|
The DEQ will be used to obtain subjective ratings of "willingness to drive".
Score range from 0 (none) to 100 (extreme) using a 100mm line anchored with none/extreme designation.
Higher score indicates higher willingness to drive.
|
7.5 hours
|
|
Biphasic Alcohol Effects Scale (BAES) - Sedative Score
Tidsramme: Baseline, 7.5 hours
|
The BAES is used to assess sedative and stimulant subjective effects of alcohol.
There are 7 sedative-related questionnaire items, each presented on a scale of 0 (not at all) to 10 (extremely), which are integrated to produce an overall sedative score (0-70).
Higher scores indicating greater sedative effects of alcohol.
Scores presented show the change from baseline to 7.5 hours.
|
Baseline, 7.5 hours
|
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Biphasic Alcohol Effects Scale (BAES) - Stimulant Score
Tidsramme: 7.5 hours
|
The BAES is used to assess sedative and stimulant subjective effects of alcohol.
There are 7 stimulant-related questionnaire items, each presented on a scale of 0 (not at all) to 10 (extremely), which are integrated to produce an overall stimulant score (0-70).
Higher scores indicating greater stimulant effects of alcohol.
|
7.5 hours
|
|
Subjective High Assessment Scale (SHAS)
Tidsramme: 7.5 hours
|
For the SHAS, participants are presented with 13 questionnaire items, displayed on a visual analog scale anchored from 0 (normal) to 10 (extremely), which assess subjective effects of alcohol.
These items are integrated to produce an overall SHAS score (0-130).
Higher score indicates greater effects of alcohol.
|
7.5 hours
|
|
Driving Performance as Assessed by Standard Deviation of Lateral Position (SDLP)
Tidsramme: Baseline, 1, 1.5, 2.5, 3.5, 4.5, 5.5, 6.5, and 7.5 hours
|
The STISIM Drive® M4000-R Console system will be used to assess driving performance, a state-of-the-art technology that has been independently validated to reflect real-world driving conditions.
SDLP (measured in cm) was calculated across all drives to get a composite index of lateral control and reported as peak change from baseline.
SDLP is the gold standard of quantifying the magnitude of driving impairment from drugs and alcohol and has excellent predictive validity to actual driving.
Scores range from 0 to no upper limit.
Higher scores represent higher magnitude of driving impairment.
|
Baseline, 1, 1.5, 2.5, 3.5, 4.5, 5.5, 6.5, and 7.5 hours
|
|
Driving Performance as Assessed by Composite Drive Score
Tidsramme: Baseline, 1, 1.5, 2.5, 3.5, 4.5, 5.5, 6.5, and 7.5 hours
|
Driving impairment will be assessed via a composite drive score.
The composite drive score is derived by integrating various driving outcomes (see primary and secondary driving outcomes).
Higher z-score indicates worse performance.
The score is on a z-score scale, meaning a score of 1 equates to 1 standard deviation outside of the participants' mean baseline performance and a Z-score of 0 represents the mean baseline performance.
This was calculated across all drives and reported as peak change from baseline.
|
Baseline, 1, 1.5, 2.5, 3.5, 4.5, 5.5, 6.5, and 7.5 hours
|
Sekundære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
|
Driving Performance as Assessed by Standard Deviation of Speed (SDSP)
Tidsramme: Baseline, 1, 1.5, 2.5, 3.5, 4.5, 5.5, 6.5, and 7.5 hours
|
The STISIM Drive® M4000-R Console system will be used to assess driving performance, a state-of-the-art technology that has been independently validated to reflect real-world driving conditions.
SDSP will be calculated across all drives to get a composite index of the variability in speed (measured in MPH) and is reported as peak change from baseline.
Scores range from 0 to no upper limit.
Higher scores represent higher magnitude of driving impairment.
|
Baseline, 1, 1.5, 2.5, 3.5, 4.5, 5.5, 6.5, and 7.5 hours
|
|
Total Run Length
Tidsramme: Baseline, 1, 1.5, 2.5, 3.5, 4.5, 5.5, 6.5, and 7.5 hours
|
The STISIM Drive® M4000-R Console system will be used to assess driving performance, a state-of-the-art technology that has been independently validated to reflect real-world driving conditions.
Total run length will be calculated across all drives and measured as peak change from baseline score (in seconds).
Higher scores represent higher magnitude of driving impairment.
|
Baseline, 1, 1.5, 2.5, 3.5, 4.5, 5.5, 6.5, and 7.5 hours
|
|
Driving Performance (Number of Speed Exceedances)
Tidsramme: Baseline, 1, 1.5, 2.5, 3.5, 4.5, 5.5, 6.5, and 7.5 hours
|
The STISIM Drive® M4000-R Console system will be used to assess driving performance, a state-of-the-art technology that has been independently validated to reflect real-world driving conditions.
Driving performance will be calculated across all drives to get a cumulative number of times participants exceed the allowable speed limit and reported as peak change from baseline.
Scores range from 0 to no upper limit.
Higher scores represent higher numbers of speed exceedances.
|
Baseline, 1, 1.5, 2.5, 3.5, 4.5, 5.5, 6.5, and 7.5 hours
|
|
Driving Performance (Number of Accidents)
Tidsramme: Baseline, 1, 1.5, 2.5, 3.5, 4.5, 5.5, 6.5, and 7.5 hours
|
The STISIM Drive® M4000-R Console system will be used to assess driving performance, a state-of-the-art technology that has been independently validated to reflect real-world driving conditions.
Driving performance will be calculated across all drives to get a cumulative number of accidents (including car collisions, pedestrians hit, etc.) and reported as peak change from baseline.
Scores range from 0 to no upper limit.
Higher scores represent higher numbers of accidents.
|
Baseline, 1, 1.5, 2.5, 3.5, 4.5, 5.5, 6.5, and 7.5 hours
|
|
Driving Performance (Total Rule Violations)
Tidsramme: Baseline, 1, 1.5, 2.5, 3.5, 4.5, 5.5, 6.5, and 7.5 hours
|
The STISIM Drive® M4000-R Console system will be used to assess driving performance, a state-of-the-art technology that has been independently validated to reflect real-world driving conditions.
Driving performance will be calculated across all drives to get a cumulative number of total rule violations (including number of missed stop signs, illegal turns, speed exceedances, etc.) and reported as peak change from baseline.
Scores range from 0 to no upper limit.
Higher scores represent higher numbers of rule violations.
All scores reported are relative to baseline, thus negative values represent a lower number of rule violations than at baseline.
|
Baseline, 1, 1.5, 2.5, 3.5, 4.5, 5.5, 6.5, and 7.5 hours
|
|
Driving Performance (Distance to Lead Vehicles)
Tidsramme: Baseline, 1, 1.5, 2.5, 3.5, 4.5, 5.5, 6.5, and 7.5 hours
|
The STISIM Drive® M4000-R Console system will be used to assess driving performance, a state-of-the-art technology that has been independently validated to reflect real-world driving conditions.
Driving performance will be calculated across all drives to get the mean distance (in meters) maintained to lead vehicles during car-following segments and reported as peak change from baseline.
Scores range from 0 to no upper limit.
Higher scores represent greater distance maintained to lead vehicles.
All scores reported are relative to baseline, thus negative values represent a shorter distance maintained than at baseline.
|
Baseline, 1, 1.5, 2.5, 3.5, 4.5, 5.5, 6.5, and 7.5 hours
|
|
Change in Field Sobriety Test - Score on Horizontal Gaze Nystagmus Test
Tidsramme: Baseline, 7.5 hours
|
Impairment will be assessed using performance on the Horizontal Gaze Nystagmus Test (HGN).
Total score will be recorded (out of possible 0-6 clues) with higher scores indicating higher impairment.
Assessed at baseline and 7.5 hours, change from baseline to 7.5 hours reported
|
Baseline, 7.5 hours
|
|
Change in Field Sobriety Test - Score on Walk and Turn Test
Tidsramme: Baseline, 7.5 hours
|
Impairment will be assessed using performance on the the Walk and Turn.
Total score will be recorded (out of a possible 0-8 clues) with higher scores indicating higher impairment.
Assessed at baseline and 7.5 hours, change from baseline to 7.5 hours reported
|
Baseline, 7.5 hours
|
|
Change in Field Sobriety Test - Score on One Leg Stand
Tidsramme: Baseline, 7.5 hours
|
Impairment will be assessed using performance on the One Leg Stand test.
Total score will be recorded (out of a possible 0-4 clues) with higher scores indicating higher impairment.
Assessed at baseline and 7.5 hours, change from baseline to 7.5 hours reported
|
Baseline, 7.5 hours
|
|
Change in Field Sobriety Test - Score on Modified Romberg Balance
Tidsramme: Baseline, 7.5 hours
|
Impairment will be assessed using performance on the Modified Romberg Balance test.
Total score will be recorded (out of a possible 0-4 clues) with higher scores indicating higher impairment.
Assessed at baseline and 7.5 hours, change from baseline to 7.5 hours reported
|
Baseline, 7.5 hours
|
|
Drug Effect Questionnaire - Like Drug Effect
Tidsramme: 7.5 hours
|
The DEQ will be used to obtain subjective ratings of "like drug effect".
Score range from 0 (none) to 100 (extreme) using a 100mm line anchored with none/extreme designation.
Higher score indicating greater "liked drug effect" rating.
|
7.5 hours
|
|
Drug Effect Questionnaire - Dislike Drug Effect
Tidsramme: 7.5 hours
|
The DEQ will be used to obtain subjective ratings of "dislike drug effect".
Score range from 0 (none) to 100 (extreme) using a 100mm line anchored with none/extreme designation.
Higher score indicating greater "dislike drug effect" rating.
|
7.5 hours
|
|
Pharmacokinetics - CMax for THC and THC Metabolites
Tidsramme: Baseline, 1, 1.5, 2.5, 3.5, 4.5, 5.5, 6.5, and 7.5 hours
|
Whole blood concentrations of THC, 11-OH-THC, and THCCOOH will be measured using quantitative liquid chromatography-tandem mass spectrometry (LC-MS-MS) analysis.
The maximum concentration (Cmax) is determined as the highest concentration reached for each individual (ng/mL) across all timepoints.
|
Baseline, 1, 1.5, 2.5, 3.5, 4.5, 5.5, 6.5, and 7.5 hours
|
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Pharmacokinetics - AUC for THC and THC Metabolites
Tidsramme: Baseline, 1, 1.5, 2.5, 3.5, 4.5, 5.5, 6.5, and 7.5 hours
|
Whole blood concentrations of THC, 11-OH-THC, and THCCOOH will be measured using quantitative liquid chromatography-tandem mass spectrometry (LC-MS-MS) analysis.
The area under the curve (AUC) is calculated cumulative across all timepoints.
|
Baseline, 1, 1.5, 2.5, 3.5, 4.5, 5.5, 6.5, and 7.5 hours
|
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Pharmacokinetics - CMax for Alcohol
Tidsramme: Baseline, 1, 1.5, 2.5, 3.5, 4.5, 5.5, 6.5, and 7.5 hours
|
BAC will be measured using the Alco-Sensor IV.
Measuring BAC is needed to confirm that participants reached the targeted BAC for a given session and to confirm adherence to pre-session alcohol abstinence requirements (g/210L).
The maximum concentration (Cmax) is determined as the highest concentration reached for each individual (ng/mL) across all timepoints.
|
Baseline, 1, 1.5, 2.5, 3.5, 4.5, 5.5, 6.5, and 7.5 hours
|
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Pharmacokinetics - AUC for Alcohol
Tidsramme: Baseline, 1, 1.5, 2.5, 3.5, 4.5, 5.5, 6.5, and 7.5 hours
|
Whole blood concentrations of Alcohol will be measured using quantitative liquid chromatography-tandem mass spectrometry (LC-MS-MS) analysis.
The area under the curve (AUC) is calculated cumulative across all timepoints.
|
Baseline, 1, 1.5, 2.5, 3.5, 4.5, 5.5, 6.5, and 7.5 hours
|
Samarbeidspartnere og etterforskere
Det er her du vil finne personer og organisasjoner som er involvert i denne studien.
Sponsor
Samarbeidspartnere
Etterforskere
- Hovedetterforsker: Tory Spindle, PhD, Johns Hopkins University
Publikasjoner og nyttige lenker
Den som er ansvarlig for å legge inn informasjon om studien leverer frivillig disse publikasjonene. Disse kan handle om alt relatert til studiet.
Studierekorddatoer
Disse datoene sporer fremdriften for innsending av studieposter og sammendragsresultater til ClinicalTrials.gov. Studieposter og rapporterte resultater gjennomgås av National Library of Medicine (NLM) for å sikre at de oppfyller spesifikke kvalitetskontrollstandarder før de legges ut på det offentlige nettstedet.
Studer hoveddatoer
Studiestart (Faktiske)
17. februar 2022
Primær fullføring (Faktiske)
15. august 2025
Studiet fullført (Faktiske)
15. august 2025
Datoer for studieregistrering
Først innsendt
11. juni 2021
Først innsendt som oppfylte QC-kriteriene
11. juni 2021
Først lagt ut (Faktiske)
18. juni 2021
Oppdateringer av studieposter
Sist oppdatering lagt ut (Faktiske)
3. august 2026
Siste oppdatering sendt inn som oppfylte QC-kriteriene
29. juli 2026
Sist bekreftet
1. juli 2026
Mer informasjon
Begreper knyttet til denne studien
Ytterligere relevante MeSH-vilkår
Andre studie-ID-numre
- IRB00290015
- 1R01DA052295-01 (U.S. NIH-stipend/kontrakt)
Plan for individuelle deltakerdata (IPD)
Planlegger du å dele individuelle deltakerdata (IPD)?
NEI
Legemiddel- og utstyrsinformasjon, studiedokumenter
Studerer et amerikansk FDA-regulert medikamentprodukt
Ja
Studerer et amerikansk FDA-regulert enhetsprodukt
Nei
Denne informasjonen ble hentet direkte fra nettstedet clinicaltrials.gov uten noen endringer. Hvis du har noen forespørsler om å endre, fjerne eller oppdatere studiedetaljene dine, vennligst kontakt register@clinicaltrials.gov. Så snart en endring er implementert på clinicaltrials.gov, vil denne også bli oppdatert automatisk på nettstedet vårt. .