Ignite Creation Date:
2025-12-24 @ 7:48 PM
Ignite Modification Date:
2025-12-27 @ 2:38 PM
Study NCT ID:
NCT06115603
Status:
RECRUITING
Last Update Posted:
2025-04-02
First Post:
2023-10-10
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
The Effects of Cannabigerol on Attention-Deficit/Hyperactivity Disorder
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D001289', 'term': 'Attention Deficit Disorder with Hyperactivity'}], 'ancestors': [{'id': 'D019958', 'term': 'Attention Deficit and Disruptive Behavior Disorders'}, {'id': 'D065886', 'term': 'Neurodevelopmental Disorders'}, {'id': 'D001523', 'term': 'Mental Disorders'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'C037036', 'term': 'cannabigerol'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'TRIPLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR'], 'maskingDescription': "Participants and researchers interacting with participants will be blind to condition. An unblinded researcher team will randomize and label all pipettes containing CBG or placebo prior to each participants' session. Participants will receive individual, 1 mL pipettes containing CBG and placebo (pipettes are indistinguishable)."}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 76}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2024-12-14', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-03', 'completionDateStruct': {'date': '2025-12', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-03-28', 'studyFirstSubmitDate': '2023-10-10', 'studyFirstSubmitQcDate': '2023-10-29', 'lastUpdatePostDateStruct': {'date': '2025-04-02', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2023-11-03', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-12', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Sustained Attention to Response Task', 'timeFrame': '75 minutes post CBG/placebo administration', 'description': 'A computerized task that measures response inhibition.'}, {'measure': 'Trail Making Test-Parts A and B (TMT-A&B)', 'timeFrame': '75 minutes post CBG/placebo administration', 'description': 'A paper-and-pencil task that measures'}, {'measure': 'Digit Symbol Substitution Test (DSST)', 'timeFrame': '75 minutes post CBG/placebo administration', 'description': 'A paper-and-pencil task that measures attention/processing speed.'}, {'measure': 'Rey Auditory Verbal Learning Test (AVLT)', 'timeFrame': '75 minutes post CBG/placebo administration', 'description': 'A paper-and-pencil/verbal test that measures verbal memory.'}, {'measure': 'Iowa Gambling Task (IGT)', 'timeFrame': '75 minutes post CBG/placebo administration', 'description': 'A computerized task that measures decision making (an indicator of impulsivity/hyperactivity).'}], 'secondaryOutcomes': [{'measure': 'Positive and Negative Affect Scale-Expanded Version', 'timeFrame': 'Baseline, 45 minutes post CBG/placebo administration, 75 minutes post CBG/placebo administration', 'description': '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.'}, {'measure': 'Karolinska Sleepiness Scale', 'timeFrame': 'Pre CBG/placebo administration, 75 minutes post CBG/placebo administration', 'description': '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.'}, {'measure': 'Brief Irritability Test', 'timeFrame': 'Pre CBG/placebo administration, 75 minutes post CBG/placebo administration', 'description': 'Self-report measure of irritability. Scores range from 5-30, with higher scores representing greater irritability.'}, {'measure': 'Numeric Rating Scale (pain)', 'timeFrame': 'Pre CBG/placebo administration, 75 minutes post CBG/placebo administration', 'description': 'Self-report measure of subjective level of pain. Scores range from 0-10, with higher scores representing greater pain.'}, {'measure': 'State-Trait Anxiety Inventory (State Version)', 'timeFrame': 'Pre CBG/placebo administration, 75 minutes post CBG/placebo administration', 'description': 'Self-report measure of state anxiety. Scores range from 20 to 80 with higher scores indicating greater anxiety.'}, {'measure': 'Visual Analog Scales', 'timeFrame': '75 minutes post CBG/placebo administration', 'description': '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.'}, {'measure': 'Global Impression of Change', 'timeFrame': '75 minutes post CBG/placebo administration', 'description': 'Self-report measure of perceived change in ADHD symptoms. This scale ranges from 1 to 7 with higher scores indicating greater improvements.'}]}, 'oversightModule': {'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Attention-Deficit/Hyperactivity Disorder']}, 'descriptionModule': {'briefSummary': '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 and 75 minutes. Daily surveys to monitor safety will be administered for one week following administration.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '55 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': "1. Between 18 and 55-years-old.\n2. BMI between 18 and 35 kg/m2.\n3. Score a 4 or above on the Adult ADHD Self-Report Scale (ASRS-v1.1) Symptom Checklist Part A.\n4. Meet diagnostic criteria for ADHD with a current severity rating of at least mild as defined by the DIAMOND.\n5. Are not pregnant or currently breastfeeding.\n6. Have no history of significant allergic condition, hypersensitivity, or allergic reactions to cannabis, cannabinoid medications, hemp products, medium chain triglyceride oil, or peppermint.\n7. Have not used CBG or any other cannabinoid products in the past 30 days.\n8. Willing to abstain from using cannabis or any THC-containing product for the duration of the study.\n9. Have never used a synthetic cannabinoid or cannabinoid analogue (e.g., dronabinol, nabilone), or a synthetic cannabinoid receptor agonist (e.g., spice, k2).\n10. 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.\n11. Willing to maintain a stable treatment regimen (i.e., no change in current medication use) for the duration of the study.\n12. Not currently taking a prescription medication for ADHD and have not been prescribed a medication for ADHD in the past six months.\n13. Not currently having thoughts of committing suicide\n14. Does not meet criteria for current severe major depressive disorder or a substance use disorder.\n15. Have not been diagnosed with bipolar disorder or psychosis.\n16. 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).\n17. Do not have history of diagnosis related to liver function and/or significantly impaired liver function (e.g., cirrhosis of the liver, hepatitis).\n18. 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.\n19. Have access to a ride to the University of Arkansas campus for research appointments.\n20. Willing to comply with current university mandates as they pertain to COVID-19 protocols (e.g., mask wearing).\n21. Do not have any serious or unstable physical health conditions including neurological or renal illness.\n22. Do not have any current or historical cardiovascular conditions, including hypotension, bradycardia, or heart block.\n23. No atrial fibrillation, bradycardia, or tachycardia detected via mobile electrocardiogram during the in-laboratory visit.\n24. No recent illicit drug use other than cannabis, or alcohol use in the 12 hours preceding the in-laboratory visit.\n25. Not currently prescribed or taking the following medications:\n\n * Warfarin\n * Clobazam\n * Valproic acid\n * Phenobarbital\n * Mechanistic Target of Rapamycin \\[mTOR\\] Inhibitors\n * Oral tacrolimus\n * St. John's wort\n * Epidiolex\n * Escitalopram\n * Cardiovascular medications\n * Strong CYP3A4 inhibitors (e.g., ketoconazole)"}, 'identificationModule': {'nctId': 'NCT06115603', 'acronym': 'CBG', 'briefTitle': 'The Effects of Cannabigerol on Attention-Deficit/Hyperactivity Disorder', 'organization': {'class': 'OTHER', 'fullName': 'University of Arkansas, Fayetteville'}, 'officialTitle': 'CBG and Attention: A Double-Blind, Randomized, Placebo-Controlled Trial Examining the Effects of Cannabigerol on Indicators of Attention-Deficit/Hyperactivity Disorder', 'orgStudyIdInfo': {'id': '2309494774'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Cannabigerol', 'description': '1mL of 80mg of Cannabigerol. Cannabigerol is a safe, legal, non-high-inducing cannabinoid obtained from the cannabis plant.', 'interventionNames': ['Drug: Cannabigerol']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo', 'description': '1mL of Placebo. Placebo is made in the form of MCT oil.', 'interventionNames': ['Other: Placebo']}], 'interventions': [{'name': 'Cannabigerol', 'type': 'DRUG', 'description': '1 mL of 80mg Cannabigerol once during experimental session', 'armGroupLabels': ['Cannabigerol']}, {'name': 'Placebo', 'type': 'OTHER', 'description': '1 mL of placebo once during experimental session', 'armGroupLabels': ['Placebo']}]}, 'contactsLocationsModule': {'locations': [{'zip': '72703', 'city': 'Fayetteville', 'state': 'Arkansas', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Ellen Leen-Feldner, PhD', 'role': 'CONTACT', 'email': 'eleenfe@uark.edu'}], 'facility': 'University of Arkansas', 'geoPoint': {'lat': 36.06258, 'lon': -94.15743}}], 'centralContacts': [{'name': 'Ellen W Leen-Feldner, PhD', 'role': 'CONTACT', 'email': 'eleenfe@uark.edu', 'phone': '4795754256'}], 'overallOfficials': [{'name': 'Ellen W Leen-Feldner, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of Arkansas'}]}, 'ipdSharingStatementModule': {'infoTypes': ['STUDY_PROTOCOL', 'SAP', 'ICF'], 'timeFrame': 'Beginning 9months and ending 36 months following publication', 'ipdSharing': 'YES', 'description': 'De-identified, individual participant data (including data dictionaries) that underlie results reported in each published report will be shared (text, tables, figures, appendices)', 'accessCriteria': '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'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Arkansas, Fayetteville', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Professor', 'investigatorFullName': 'Ellen Leen-Feldner', 'investigatorAffiliation': 'University of Arkansas, Fayetteville'}}}}