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Effektene av Cannabigerol på oppmerksomhetsunderskudd/hyperaktivitetsforstyrrelse (CBG)

4. november 2026 oppdatert av: Ellen Leen-Feldner, University of Arkansas, Fayetteville

CBG og oppmerksomhet: En dobbeltblind, randomisert, placebokontrollert, crossover-forsøk som undersøker effekten av Cannabigerol på symptomer på oppmerksomhetsunderskudd/hyperaktivitetsforstyrrelse og relaterte resultater

The goal of this clinical trial is to evaluate the effects of Cannabigerol (CBG) on indicators of Attention-Deficit/Hyperactivity Disorder (ADHD) in a sample of participants indicating/reporting symptoms associated with ADHD. The main question it aims to answer is: Does CBG reduce ADHD-related indicators relative to placebo? Participants will administer an acute dose of placebo or 80mg CBG and complete outcome measures at 45 minutes (PANAS only) and 75 minutes. Daily surveys to monitor safety will be administered for one week following administration.

Studieoversikt

Studietype

Intervensjonell

Registrering (Faktiske)

67

Fase

  • Fase 2

Kontakter og plasseringer

Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.

Studiesteder

    • Arkansas
      • Fayetteville, Arkansas, Forente stater, 72703
        • University of Arkansas

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

18 år til 55 år (Voksen)

Tar imot friske frivillige

Ja

Kjønn som er kvalifisert for studier

Alle

Beskrivelse

  1. Between 18 and 55-years-old.

  2. BMI between 18 and 35 kg/m2.

  3. Score a 2 or above on the Adult ADHD Self-Report Scale (ASRS) Symptom Checklist Part A or have an official ADHD diagnosis.

  4. Meet diagnostic criteria for ADHD with a current severity rating of at least mild as defined by the DIAMOND.

  5. Are not pregnant or currently breastfeeding.

  6. Have no history of significant allergic condition, hypersensitivity, or allergic reactions to cannabis, cannabinoid medications, hemp products, medium chain triglyceride oil, or peppermint.

  7. Have not used CBG or any other cannabinoid products in the past 30 days.

  8. Willing to abstain from using cannabis or any THC-containing product for the duration of the study.

  9. Have never used a synthetic cannabinoid or cannabinoid analogue (e.g., dronabinol, nabilone), or a synthetic cannabinoid receptor agonist (e.g., spice, k2).

  10. Have not been exposed to any investigational drug or device 30 days prior to screening and you have no plans to take an investigational drug during the study.

  11. Willing to maintain a stable treatment regimen (i.e., no change in current medication use) for the duration of the study.

  12. Not currently taking a prescription medication for ADHD and have not been prescribed a medication for ADHD in the past six months.

  13. Not currently having thoughts of committing suicide

  14. Does not meet criteria for current severe major depressive disorder or a substance use disorder.

  15. Have not been diagnosed with bipolar disorder or psychosis.

  16. Do not have an acute illness, such as a respiratory infection or other illness that would interfere with study participation; not currently taking medication for an acute illness (e.g., antibiotic).

  17. Do not have history of diagnosis related to liver function and/or significantly impaired liver function (e.g., cirrhosis of the liver, hepatitis).

  18. Willing to ensure they have used effective contraception (for example, oral contraception, double barrier, intra-uterine device) for 30 prior to the study and for 30 days after study completion.

  19. Have access to a ride to the University of Arkansas campus for research appointments.

  20. Willing to comply with current university mandates as they pertain to COVID-19 protocols (e.g., mask wearing).

  21. Do not have any serious or unstable physical health conditions including neurological or renal illness.

  22. Do not have any current or historical cardiovascular conditions, including hypotension, bradycardia, or heart block.

  23. No atrial fibrillation, bradycardia, or tachycardia detected via mobile electrocardiogram during the in-laboratory visit.

  24. No recent illicit drug use other than cannabis, or alcohol use in the 12 hours preceding the in-laboratory visit.

  25. Not currently prescribed or taking the following medications:

    • Warfarin
    • Clobazam
    • Valproic acid
    • Phenobarbital
    • Mechanistic Target of Rapamycin [mTOR] Inhibitors
    • Oral tacrolimus
    • St. John's wort
    • Epidiolex
    • Escitalopram
    • Cardiovascular medications
    • Strong CYP3A4 inhibitors (e.g., ketoconazole)

Studieplan

Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.

Hvordan er studiet utformet?

Designdetaljer

  • Primært formål: Behandling
  • Tildeling: Randomisert
  • Intervensjonsmodell: Parallell tildeling
  • Masking: Trippel

Våpen og intervensjoner

Deltakergruppe / Arm
Intervensjon / Behandling
Aktiv komparator: Cannabigerol

1mL of 80mg of Cannabigerol. Cannabigerol is a safe, legal, non-high-inducing cannabinoid obtained from the cannabis plant.

1 mL of 80mg Cannabigerol once during experimental session

Placebo komparator: Placebo

1mL of Placebo. Placebo is made in the form of MCT oil.

1 mL of placebo once during experimental session

Hva måler studien?

Primære resultatmål

Resultatmål
Tiltaksbeskrivelse
Tidsramme
Sustained Attention to Response Task
Tidsramme: 75 minutes post CBG/placebo administration

A computerized task that measures response inhibition.

75 minutes post CBG/placebo administration
Digit Symbol Substitution Test (DSST)
Tidsramme: 75 minutes post CBG/placebo administration

A paper-and-pencil task that measures attention/processing speed.

75 minutes post CBG/placebo administration
Rey Auditory Verbal Learning Test (AVLT)
Tidsramme: 75 minutes post CBG/placebo administration

A paper-and-pencil/verbal test that measures verbal memory.

75 minutes post CBG/placebo administration
Iowa Gambling Task (IGT)
Tidsramme: 75 minutes post CBG/placebo administration

A computerized task that measures decision making (an indicator of impulsivity/hyperactivity).

75 minutes post CBG/placebo administration
Trail Making Test-Parts A and B (TMT-A&B)
Tidsramme: 75 minutes post CBG/placebo administration

A paper-and-pencil task that measures attention, psychomotor speed, and cognitive flexibility.

75 minutes post CBG/placebo administration

Sekundære resultatmål

Resultatmål
Tiltaksbeskrivelse
Tidsramme
Positive and Negative Affect Scale-Expanded Version
Tidsramme: Baseline, 45 minutes post CBG/placebo administration, 75 minutes post CBG/placebo administration

Self-report measure of positive and negative affect. Scores range from 30-150 on each of the two types of affects, with higher scores representing greater affect.

Baseline, 45 minutes post CBG/placebo administration, 75 minutes post CBG/placebo administration
Karolinska Sleepiness Scale
Tidsramme: Pre CBG/placebo administration, 75 minutes post CBG/placebo administration

Self-report measure of subjective level of sleepiness at a particular time during the day. Scores range from 1-10, with higher scores representing greater sleepiness.

Pre CBG/placebo administration, 75 minutes post CBG/placebo administration
Brief Irritability Test
Tidsramme: Pre CBG/placebo administration, 75 minutes post CBG/placebo administration

Self-report measure of irritability. Scores range from 5-30, with higher scores representing greater irritability.

Pre CBG/placebo administration, 75 minutes post CBG/placebo administration
Numeric Rating Scale (pain)
Tidsramme: Pre CBG/placebo administration, 75 minutes post CBG/placebo administration

Self-report measure of subjective level of pain. Scores range from 0-10, with higher scores representing greater pain.

Pre CBG/placebo administration, 75 minutes post CBG/placebo administration
State-Trait Anxiety Inventory (State Version)
Tidsramme: Pre CBG/placebo administration, 75 minutes post CBG/placebo administration

Self-report measure of state anxiety. Scores range from 20 to 80 with higher scores indicating greater anxiety.

Pre CBG/placebo administration, 75 minutes post CBG/placebo administration
Visual Analog Scales
Tidsramme: 75 minutes post CBG/placebo administration

Self-report of state-like states (e.g., anxiety, hunger). This scale ranges from 0 to 100 with higher scores indicating higher levels of the indication.

75 minutes post CBG/placebo administration
Global Impression of Change
Tidsramme: 75 minutes post CBG/placebo administration

Self-report measure of perceived change in ADHD symptoms. This scale ranges from 1 to 7 with higher scores indicating greater improvements.

75 minutes post CBG/placebo administration

Samarbeidspartnere og etterforskere

Det er her du vil finne personer og organisasjoner som er involvert i denne studien.

Etterforskere

  • Hovedetterforsker: Ellen W Leen-Feldner, PhD, University of Arkansas

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)

14. desember 2024

Primær fullføring (Faktiske)

15. juli 2026

Studiet fullført (Faktiske)

30. juli 2026

Datoer for studieregistrering

Først innsendt

10. oktober 2023

Først innsendt som oppfylte QC-kriteriene

29. oktober 2023

Først lagt ut (Faktiske)

3. november 2023

Oppdateringer av studieposter

Sist oppdatering lagt ut (Faktiske)

9. november 2026

Siste oppdatering sendt inn som oppfylte QC-kriteriene

4. november 2026

Sist bekreftet

1. november 2026

Mer informasjon

Begreper knyttet til denne studien

Plan for individuelle deltakerdata (IPD)

Planlegger du å dele individuelle deltakerdata (IPD)?

JA

IPD-planbeskrivelse

De-identified, individual participant data (including data dictionaries) that underlie results reported in each published report will be shared (text, tables, figures, appendices)

IPD-delingstidsramme

Beginning 9months and ending 36 months following publication

Tilgangskriterier for IPD-deling

Researchers who provide a methodologically sound proposal. Inquiries should be directed to eleenfe@uark.edu; Requestors will need to sign a data agreement to gain access

IPD-deling Støtteinformasjonstype

  • STUDY_PROTOCOL
  • SEVJE
  • ICF

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. .

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