- ICH GCP
- Registre américain des essais cliniques
- Essai clinique NCT06115603
Les effets du cannabigérol sur le trouble déficitaire de l’attention/hyperactivité (CBG)
CBG et attention : un essai croisé en double aveugle, randomisé, contrôlé par placebo, examinant les effets du cannabigérol sur les symptômes du trouble déficitaire de l'attention/hyperactivité et les résultats associés
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.
Aperçu de l'étude
Statut
Les conditions
Intervention / Traitement
Type d'étude
Inscription (Réel)
Phase
- Phase 2
Contacts et emplacements
Lieux d'étude
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Arkansas
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Fayetteville, Arkansas, États-Unis, 72703
- University of Arkansas
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Critères de participation
Critère d'éligibilité
Âges éligibles pour étudier
Accepte les volontaires sains
Sexes éligibles pour l'étude
La description
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Between 18 and 55-years-old.
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BMI between 18 and 35 kg/m2.
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Score a 2 or above on the Adult ADHD Self-Report Scale (ASRS) Symptom Checklist Part A or have an official ADHD diagnosis.
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Meet diagnostic criteria for ADHD with a current severity rating of at least mild as defined by the DIAMOND.
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Are not pregnant or currently breastfeeding.
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Have no history of significant allergic condition, hypersensitivity, or allergic reactions to cannabis, cannabinoid medications, hemp products, medium chain triglyceride oil, or peppermint.
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Have not used CBG or any other cannabinoid products in the past 30 days.
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Willing to abstain from using cannabis or any THC-containing product for the duration of the study.
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Have never used a synthetic cannabinoid or cannabinoid analogue (e.g., dronabinol, nabilone), or a synthetic cannabinoid receptor agonist (e.g., spice, k2).
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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.
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Willing to maintain a stable treatment regimen (i.e., no change in current medication use) for the duration of the study.
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Not currently taking a prescription medication for ADHD and have not been prescribed a medication for ADHD in the past six months.
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Not currently having thoughts of committing suicide
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Does not meet criteria for current severe major depressive disorder or a substance use disorder.
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Have not been diagnosed with bipolar disorder or psychosis.
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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).
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Do not have history of diagnosis related to liver function and/or significantly impaired liver function (e.g., cirrhosis of the liver, hepatitis).
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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.
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Have access to a ride to the University of Arkansas campus for research appointments.
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Willing to comply with current university mandates as they pertain to COVID-19 protocols (e.g., mask wearing).
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Do not have any serious or unstable physical health conditions including neurological or renal illness.
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Do not have any current or historical cardiovascular conditions, including hypotension, bradycardia, or heart block.
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No atrial fibrillation, bradycardia, or tachycardia detected via mobile electrocardiogram during the in-laboratory visit.
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No recent illicit drug use other than cannabis, or alcohol use in the 12 hours preceding the in-laboratory visit.
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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)
Plan d'étude
Comment l'étude est-elle conçue ?
Détails de conception
- Objectif principal: Traitement
- Répartition: Randomisé
- Modèle interventionnel: Affectation parallèle
- Masquage: Tripler
Armes et Interventions
Groupe de participants / Bras |
Intervention / Traitement |
|---|---|
|
Comparateur actif: 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 |
|
Comparateur placebo: Placebo
1mL of Placebo. Placebo is made in the form of MCT oil. |
1 mL of placebo once during experimental session |
Que mesure l'étude ?
Principaux critères de jugement
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
|
Sustained Attention to Response Task
Délai: 75 minutes post CBG/placebo administration
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A computerized task that measures response inhibition. |
75 minutes post CBG/placebo administration
|
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Digit Symbol Substitution Test (DSST)
Délai: 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)
Délai: 75 minutes post CBG/placebo administration
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A paper-and-pencil/verbal test that measures verbal memory. |
75 minutes post CBG/placebo administration
|
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Iowa Gambling Task (IGT)
Délai: 75 minutes post CBG/placebo administration
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A computerized task that measures decision making (an indicator of impulsivity/hyperactivity). |
75 minutes post CBG/placebo administration
|
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Trail Making Test-Parts A and B (TMT-A&B)
Délai: 75 minutes post CBG/placebo administration
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A paper-and-pencil task that measures attention, psychomotor speed, and cognitive flexibility. |
75 minutes post CBG/placebo administration
|
Mesures de résultats secondaires
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
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Positive and Negative Affect Scale-Expanded Version
Délai: Baseline, 45 minutes post CBG/placebo administration, 75 minutes post CBG/placebo administration
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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
|
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Karolinska Sleepiness Scale
Délai: Pre CBG/placebo administration, 75 minutes post CBG/placebo administration
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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
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Brief Irritability Test
Délai: Pre CBG/placebo administration, 75 minutes post CBG/placebo administration
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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
|
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Numeric Rating Scale (pain)
Délai: Pre CBG/placebo administration, 75 minutes post CBG/placebo administration
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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
|
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State-Trait Anxiety Inventory (State Version)
Délai: Pre CBG/placebo administration, 75 minutes post CBG/placebo administration
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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
|
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Visual Analog Scales
Délai: 75 minutes post CBG/placebo administration
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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
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Global Impression of Change
Délai: 75 minutes post CBG/placebo administration
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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
|
Collaborateurs et enquêteurs
Parrainer
Les enquêteurs
- Chercheur principal: Ellen W Leen-Feldner, PhD, University of Arkansas
Dates d'enregistrement des études
Dates principales de l'étude
Début de l'étude (Réel)
Achèvement primaire (Réel)
Achèvement de l'étude (Réel)
Dates d'inscription aux études
Première soumission
Première soumission répondant aux critères de contrôle qualité
Première publication (Réel)
Mises à jour des dossiers d'étude
Dernière mise à jour publiée (Réel)
Dernière mise à jour soumise répondant aux critères de contrôle qualité
Dernière vérification
Plus d'information
Termes liés à cette étude
Termes MeSH pertinents supplémentaires
Autres numéros d'identification d'étude
- 2309494774
Plan pour les données individuelles des participants (IPD)
Prévoyez-vous de partager les données individuelles des participants (DPI) ?
Description du régime IPD
De-identified, individual participant data (including data dictionaries) that underlie results reported in each published report will be shared (text, tables, figures, appendices)
Délai de partage IPD
Beginning 9months and ending 36 months following publication
Critères d'accès au partage IPD
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
Type d'informations de prise en charge du partage d'IPD
- PROTOCOLE D'ÉTUDE
- SÈVE
- CIF
Informations sur les médicaments et les dispositifs, documents d'étude
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