Status:
COMPLETED
Assessing the Effects of a Cannabidiol Derived From Hemp Supplement in Healthy Adults
Lead Sponsor:
University of South Carolina
Collaborating Sponsors:
Nutrasource Pharmaceutical and Nutraceutical Services, Inc.
Conditions:
Healthy
Safety Issues
Eligibility:
All Genders
18-55 years
Phase:
NA
Brief Summary
The purpose of this prospective, randomized, double-blind, placebo-controlled trial is to assess the physiological, biochemical, and psychometric impacts of a brand-specific hemp-derived cannabidiol p...
Detailed Description
Cannabis contains several phyto-cannabinoids among which Δ9-tetrahydrocannabinol (THC) and cannabidiol (CBD) are most widely known. THC is the main compound responsible for the psychoactive properties...
Eligibility Criteria
Inclusion
- body mass index of 19.0 to 34.9 kg/m2 (normal weight through Class I obesity)
- Agree to refrain from alcohol consumption for at least 48 hours prior to each visit.
- Willing to practice acceptable measures of birth control and sexually transmitted infections prevention by using double-barrier contraceptive measures (both males and females) throughout the study duration.
- Willing and able to agree to the requirements and restrictions of this study including fasting before blood draw on all visits for laboratory assessment.
- Willing to give voluntary consent, be able to understand and read the questionnaires, carry out all study-related procedures, communicate effectively with the study staff, and agree to allow any study related evaluations.
Exclusion
- Have a known sensitivity or allergy to any of the investigational products or their ingredients.
- Female participants who are lactating, pregnant or planning to become pregnant during the study as confirmed at the baseline (visit 2) or male participants of reproductive potential in a heterosexual relationship planning a pregnancy as confirmed at the baseline visit.
- Documented medical history of immune disorder (such as Human immunodeficiency Virus/Acquired immunodeficiency syndrome), hepatitis B or hepatitis C, or reported immune disorder diagnosis.
- Active psychiatric disorder requiring hospitalization within the 12 months prior to screening or currently on medication(s) to treat any psychiatric disorder(s).
- Any cognitive impairment that would, in the opinion of the Investigator, preclude study participation or compliance with study procedures (e.g., Alzheimer's, dementia).
- History of malignancy or those with any first-degree relatives with a history of cancer (e.g., familial cancer disorders) within 5 years.
- History of clinically significant cardiovascular, respiratory, renal, cerebrovascular, metabolic, pulmonary, gastrointestinal, neurological, hematological, autoimmune, lymphatic, psychiatric, chronic pain and sleep disorders, hepatobiliary (with the exception of Gilbert's syndrome or asymptomatic gallstones) or endocrine disorders, including individuals with Type I or Type II diabetes, or other clinically significant medical condition that, in the opinion of the Investigator, may preclude safe study participation.
- Participants with controlled or uncontrolled hypertension including stage 1 hypertension (systolic blood pressure ≥129 mmHg and diastolic blood pressure ≥89 mmHg).
- Participants who are on medications as prescribed for any of the aforementioned exclusionary criteria. Participants on stable dose of thyroid medication (no dosage changes within last 3 months) are acceptable.
- Consumption of prescription or non-prescription: angiotensin converting enzyme inhibitors, angiotensin receptor blockers, barbiturates, cocaine, ethanol, selective serotonin reuptake inhibitor, protease inhibitors, warfarin, sildenafil, theophylline, tricyclic antidepressants and any other medications
- Receipt or use of an investigational product in another research study within 30 days or 5 half lives (whichever is longer) prior to baseline (visit 2) or currently participating in another study
- Receipt or use of an investigational product in another research study within 30 days or 5 half lives (whichever is longer) prior to baseline (visit 2) or currently participating in another study
- Current or recent use (within one month prior to visit 2) of cannabis (e.g., marijuana) or cannabis related products (e.g., CBD) in any ingestible or inhalable forms.
- Positive urine drug test for THC or drugs of abuse (Amphetamine, cocaine, marijuana, methamphetamine, and opiates) at baseline (visit 2).
- Safety blood tests at screening more than 2 times the upper limit of normal (ULN) for liver or kidney function tests.
- Safety blood tests at screening more than 2 times the upper limit of normal (ULN) for liver or kidney function tests.
- Fasting blood glucose of ≥160 mg/dL (after a repeat that confirms the original result) at screening.
- Any other condition or abnormality that, in the opinion of the investigator, would compromise the safety of the participant or the quality of the study data.
Key Trial Info
Start Date :
January 18 2022
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
October 30 2022
Estimated Enrollment :
56 Patients enrolled
Trial Details
Trial ID
NCT05212402
Start Date
January 18 2022
End Date
October 30 2022
Last Update
November 1 2022
Active Locations (1)
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1
University of South Carolina Sport Science Lab
Columbia, South Carolina, United States, 29208