Trial reportCNS drugs2018
A Phase I, Randomized, Double-Blind, Placebo-Controlled, Single Ascending Dose, Multiple Dose, and Food Effect Trial of the Safety, Tolerability and Pharmacokinetics of Highly Purified Cannabidiol in Healthy Subjects.
Trial report in CNS drugs, 2018. The graph could read no effect estimate from its abstract, so it casts no vote on the map. An erratum has been issued. It is linked to 3 registered trials, which are not on this map. Cited by 255 papers, 8 of them syntheses that pooled it.
What it found
Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.
The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.
The trial behind it
Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.
CBD Cannabis Extract: Pharmacokinetic Studies
The Effects of Topical Cannabidiol Cream on Post-exercise Recovery
A Randomized, Open-Label, 4-Way Crossover, Pharmacokinetic Study to Compare CBD-NE to Epidyolex in Healthy Adult Volunteers Under Both Fed and Fasted Conditions
Who cites it
255 citing papers in PubMed, 8 syntheses or guidelines pooled it.
- Quantitative summary on the human pharmacokinetic properties of cannabidiol to accelerate scientific clinical application of cannabis.Naunyn-Schmiedeberg's archives of pharmacology · 2024Pooled it
- Pharmacokinetics of Cannabidiol: A Systematic Review and Meta-Regression Analysis.Cannabis and cannabinoid research · 2024Pooled it
- Interactions between antiseizure medications and foods and drinks: A systematic review.Epilepsia open · 2024Pooled it
- The Role of Cannabidiol in Liver Disease: A Systemic Review.International journal of molecular sciences · 2024Pooled it
- The Effectiveness and Safety of Cannabidiol in Non-seizure-related Indications: A Systematic Review of Published Randomized Clinical Trials.Pharmaceutical medicine · 2022Pooled it
- Cannabidiol in clinical and preclinical anxiety research. A systematic review into concentration-effect relations using the IB-de-risk tool.Journal of psychopharmacology (Oxford, England) · 2022Pooled it
- Immunomodulatory Potential of Cannabidiol in Multiple Sclerosis: a Systematic Review.Journal of neuroimmune pharmacology : the official journal of the Society on NeuroImmune Pharmacology · 2021Pooled it
- Food effects on the formulation, dosing, and administration of cannabidiol (CBD) in humans: A systematic review of clinical studies.Pharmacotherapy · 2021Pooled it
- An opioid-withholding human laboratory paradigm during opioid agonist treatment for opioid use disorder and chronic pain: Phase- and dose-dependent effects of cannabidiol.Neuropsychopharmacology : official publication of the American College of Neuropsychopharmacology · 2026Trial
- Comparative Pharmacokinetics and Safety of Cannabidiol in a Powder Formulation, CBtruCNS drugs · 2026Trial
- Influence of Cannabidiol Use on Visual Function and Optical Quality: A Randomized Controlled Trial.Translational vision science & technology · 2025Trial
- The neural and psychophysiological effects of cannabidiol in youth with alcohol use disorder: A randomized controlled clinical trial.Neuropsychopharmacology : official publication of the American College of Neuropsychopharmacology · 2025Trial
- Same-Day Sedative and Night-Time Sleep Effects Following Combined Cannabinoid Formulations: A Randomised-Controlled Trial.Clinical drug investigation · 2025Trial
- An open-label phase I comparator-controlled clinical trial to assess tolerability and pharmacokinetics of IHL-675 A a fixed dose combination of cannabidiol plus hydroxychloroquine in healthy volunteers.Scientific reports · 2025Trial
- A high-fat meal significantly impacts the bioavailability and biphasic absorption of cannabidiol (CBD) from a CBD-rich extract in men and women.Scientific reports · 2025Trial
- Double-Blind, Randomized, Placebo-Controlled, Crossover Study of Oral Cannabidiol and Tetrahydrocannabinol for Essential Tremor.Tremor and other hyperkinetic movements (New York, N.Y.) · 2025Trial
- Impact of Dietary Fat and Oral Delivery System on Cannabigerol Pharmacokinetics in Adults.Cannabis and cannabinoid research · 2024Trial
- Dose-dependent effects of oral cannabidiol and delta-9-tetrahydrocannabinol on serum anandamide and related N-acylethanolamines in healthy volunteers.BMJ mental health · 2024Trial
- Cannabidiol for moderate-severe insomnia: a randomized controlled pilot trial of 150 mg of nightly dosing.Journal of clinical sleep medicine : JCSM : official publication of the American Academy of Sleep Medicine · 2024Trial
- Short-Term Cannabidiol with Δ-9-Tetrahydrocannabinol in Parkinson's Disease: A Randomized Trial.Movement disorders : official journal of the Movement Disorder Society · 2024Trial
195 more citing papers are in PubMed but not listed here.
Corrections and comments
- Erratum issued
Authors and funding
5 authors.
Funding
No grant is acknowledged in the PubMed record.
Abstract
backgroundA formal single ascending and multiple dose pharmacokinetic (PK) trial of cannabidiol (CBD) oral solution was required to determine the safety and tolerability of CBD, the maximum tolerated dose, and to examine the effect of food on CBD PK parameters.
objectiveThis trial assessed the safety, tolerability and PK of CBD oral solution in healthy adult volunteers, as well as the effect of food on CBD PK parameters.
methodsThe study consisted of three arms: single ascending dose (1500, 3000, 4500 or 6000 mg CBD [n = 6 per group]/placebo [n = 8; 2 per CBD dose group]), multiple dose (750 or 1500 mg CBD [n = 9 per group]/placebo [n = 6; 3 per CBD dose group] twice daily), and food effect (1500 mg CBD single dose [n = 12]). All subjects completed all trial arms and were analyzed as planned.
resultsCBD was generally well tolerated. Diarrhea, nausea, headache, and somnolence were the most common adverse events (AEs) across all trial arms, with an increased incidence of some gastrointestinal and nervous system disorder AEs (most notably diarrhea and headache) apparent in subjects taking CBD compared with placebo. All AEs were of mild or moderate severity; none were severe or serious. There were no deaths or discontinuations in the trial. After single oral doses, CBD appeared rapidly in plasma; time to maximum plasma concentration (t
conclusionCBD was generally well tolerated. Most AEs were mild in severity; none were severe or serious. The safety and PK profile support twice-daily administration of CBD.
Indexed as
Identifiers
What OpenQuestion holds
Registered trials
Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.