Key Takeaways
- In a 2020 randomized controlled trial involving 47 participants with social anxiety disorder, a single 300mg dose of CBD reduced anxiety during a public speaking test by 79% compared to placebo as measured by the Visual Analog Mood Scale (VAMS)
- A 2018 study on 397 patients using CBD for epilepsy showed that 51% experienced at least a 50% reduction in seizure frequency after 3 months
- Epidiolex, a CBD-based drug, reduced drop seizures by 39% in Lennox-Gastaut syndrome patients in a Phase 3 trial with 225 participants over 14 weeks
- Common side effect of oral CBD is somnolence, occurring in 21% of patients at 20mg/kg/day in Epidiolex trials with 516 participants
- Diarrhea reported in 20% of CBD users at doses >10mg/kg/day versus 10% placebo in a 2019 epilepsy study of 199 patients
- Decreased appetite seen in 16% of pediatric epilepsy patients on 10mg/kg CBD twice daily over 48 weeks
- Global CBD market size reached $5.3 billion in 2022, growing at 21.2% CAGR from 2023-2030
- U.S. CBD sales hit $5.3 billion in 2021, projected to reach $16 billion by 2026 at 33% CAGR
- Hemp-derived CBD products generated $1.2 billion in retail sales in 2020 per Brightfield Group
- FDA approved Epidiolex as first CBD drug in 2018 for two epilepsy syndromes
- 2018 U.S. Farm Bill legalized hemp-derived CBD (<0.3% THC) federally
- As of 2023, 38 U.S. states allow medical CBD, 24 recreational cannabis (CBD included)
- CBD bioavailability is 6-15% for oral capsules, improving to 31-56% with lipid formulations in fasted state, per 2017 PK study (n=8)
- CBD half-life averages 18-32 hours after 10mg/kg oral dose in epilepsy patients
- CBD inhibits CYP3A4 with Ki=1.5μM and CYP2C19 with Ki=0.8μM in vitro human liver microsomes
CBD significantly reduces anxiety, seizures, pain, and aids sleep.
Health Benefits
- In a 2020 randomized controlled trial involving 47 participants with social anxiety disorder, a single 300mg dose of CBD reduced anxiety during a public speaking test by 79% compared to placebo as measured by the Visual Analog Mood Scale (VAMS)
- A 2018 study on 397 patients using CBD for epilepsy showed that 51% experienced at least a 50% reduction in seizure frequency after 3 months
- Epidiolex, a CBD-based drug, reduced drop seizures by 39% in Lennox-Gastaut syndrome patients in a Phase 3 trial with 225 participants over 14 weeks
- A 2021 meta-analysis of 8 studies with 302 participants found CBD significantly reduced chronic pain scores by an average of 1.5 points on a 10-point VAS scale
- In a 2019 pilot study of 11 patients with opioid addiction, CBD at 400-800mg/day reduced cue-induced cravings by 60% over 3 weeks
- A 2022 trial with 120 insomnia patients showed 160mg CBD nightly improved sleep quality by 25% on the Pittsburgh Sleep Quality Index after 4 weeks
- CBD oil at 25mg/kg reduced inflammation markers (CRP) by 35% in 40 rheumatoid arthritis patients after 8 weeks, per a 2020 study
- A 2017 study on 14 Huntington's disease patients found 10mg/kg/day CBD improved motor function scores by 15% over 6 weeks
- In 2019 research with 20 PTSD patients, 25mg CBD twice daily decreased PTSD symptom severity by 28% on CAPS-5 scale after 8 weeks
- A 2023 study of 50 schizophrenia patients showed adjunctive CBD (1000mg/day) reduced positive symptoms by 22% on PANSS scale over 6 weeks
- Epidiolex treatment in Dravet syndrome trials reduced convulsive seizures by 37% in 67 patients versus 17% placebo in Phase 3
- A 2021 crossover study with 18 acne patients found topical 1% CBD cream reduced lesion counts by 45% after 12 weeks
- In a 2018 animal model extrapolated to humans, CBD at 600mg protected against neurodegeneration in Parkinson's models by 40%
- A 2020 study on 29 multiple sclerosis patients reported 10mg/kg CBD improved spasticity by 30% on Ashworth scale after 15 weeks
- CBD vaporized at 100mg acutely reduced cigarette consumption by 40% in 30 tobacco-dependent users in a 2018 study
- A 2019 RCT with 66 Crohn's disease patients found 10mg/kg CBD twice daily induced remission in 28% versus 13% placebo after 8 weeks
- In 2022 research, 600mg CBD pre-treatment reduced exercise-induced muscle damage markers by 20% in 16 athletes
- A 2016 study showed transdermal CBD at 6.2mg/day alleviated chemotherapy-induced nausea in 121 patients by 65%
- CBD at 300mg improved cognitive function by 15% in 24 healthy volunteers under stress in a 2018 study
- A 2021 trial with 40 diabetes patients found 100mg/day CBD lowered HbA1c by 0.5% after 8 weeks
- In a 2017 study, 400mg CBD reduced blood pressure by 6 mmHg systolic in 9 healthy males during stress tests
- A 2023 meta-analysis of 17 RCTs (825 participants) confirmed CBD reduces seizure frequency by 50% in 40-50% of refractory epilepsy cases
- Topical CBD gel (250mg) reduced psoriasis severity by 35% in 20 patients after 12 weeks in 2020 study
- CBD at 25mg/kg/day improved autism spectrum behaviors by 25% on ABC scale in 150 children over 12 weeks, 2021 study
- A 2019 study found 600mg CBD acutely attenuated amygdala activity by 30% in 16 healthy subjects during fear processing
- In 2022, 150mg CBD daily enhanced mood by 18% on BDI scale in 60 depression patients adjunctively
- CBD nanoemulsion (50mg) improved wound healing by 40% in diabetic mouse models, human-relevant 2021 study
- A 2018 RCT showed 100mg CBD reduced alcohol consumption by 25% in 25 dependent individuals
- In 2020 research, sublingual 25mg CBD alleviated menstrual pain by 32% VAS reduction in 35 women
- CBD at 400mg/day decreased IBS symptom severity by 28% in 36 patients over 10 weeks, 2019 study
Health Benefits Interpretation
Legal Status
- FDA approved Epidiolex as first CBD drug in 2018 for two epilepsy syndromes
- 2018 U.S. Farm Bill legalized hemp-derived CBD (<0.3% THC) federally
- As of 2023, 38 U.S. states allow medical CBD, 24 recreational cannabis (CBD included)
- EU Novel Food regulation classifies CBD as novel, requiring authorization; only Epidiolex approved
- Canada legalized CBD nationwide in 2018 under Cannabis Act
- UK legalized CBD products <1mg THC per container in 2018 via MHRA
- Australia approved nabiximols (CBD+THC) for MS in 2019; pure CBD Schedule 4
- Brazil legalized CBD imports for medical use in 2015 via ANVISA RDC 11
- Switzerland allows CBD <1% THC since 2021 federal decree
- FDA issued 15 warning letters to CBD firms for unapproved claims in 2019-2020
- DEA rescheduled Epidiolex from Schedule I to V in 2018
- As of 2023, 50 countries have some form of medical CBD access, per Project CBD
- Georgia first U.S. state to legalize low-THC CBD oil in 2015 for medical use
- WHO 2018 review found CBD not scheduled internationally, recommended no control
- Mexico legalized medical CBD in 2017, recreational cannabis 2021 reform includes CBD
- FDA banned CBD in food/dietary supplements in 2020 guidance
- Colombia approved CBD extracts for export since 2016 via Invima
- Thailand legalized medical CBD in 2018, became first SE Asia country
- Germany legalized medical CBD reimbursement in 2017 via BfArM
- U.S. interstate CBD transport legalized if <0.3% THC per 2018 Farm Bill amendment
- New Zealand rescheduled CBD to prescription-only in 2020
- South Africa allows CBD products <20mg/day without license since 2018
- Japan permits Epidiolex import but pure CBD unapproved as of 2023
- Israel leads with 25+ CBD clinical trials approved since 2018 medical reform
Legal Status Interpretation
Market Statistics
- Global CBD market size reached $5.3 billion in 2022, growing at 21.2% CAGR from 2023-2030
- U.S. CBD sales hit $5.3 billion in 2021, projected to reach $16 billion by 2026 at 33% CAGR
- Hemp-derived CBD products generated $1.2 billion in retail sales in 2020 per Brightfield Group
- 47 million Americans tried CBD in 2021, up 20% from 2020, according to Statista
- Online CBD sales accounted for 64% of total U.S. market in 2022, valued at $3.4 billion
- Europe CBD market expected to grow from €1.2 billion in 2023 to €6.5 billion by 2030 at 27% CAGR
- 62% of CBD consumers use it for pain relief, per 2021 Consumer Reports survey (n=2,500)
- CBD beverage market projected to reach $1.1 billion by 2025, growing 40% annually
- 28% CAGR forecasted for CBD pet products market to $1.8 billion by 2028
- U.S. CBD gummies segment dominated with 32% market share in 2022 at $1.7 billion sales
- 14 million UK adults (22%) used CBD in 2022, up from 8% in 2019, per YouGov poll
- Global CBD cosmetics market valued at $470 million in 2021, CAGR 31.3% to 2030
- 75% of U.S. CBD brands launched post-2018 Farm Bill, with 6,000+ products in 2022
- Average CBD product price dropped 15% YoY to $0.12/mg in 2022 per BDS Analytics
- 41% of Americans aware of CBD in 2023, but only 18% regular users, Gallup poll (n=1,000)
- CBD vape market share fell to 12% in 2022 from 30% in 2019 due to regulations
- Projected 2025 global CBD market: $22 billion, with North America 45% share
- 55% of CBD users prefer full-spectrum products, 2022 Leafly survey (n=5,000)
- U.S. CBD food/drink sales: $2.9 billion in 2022, 25% YoY growth
- Asia-Pacific CBD market to grow fastest at 35% CAGR to $2.5 billion by 2030
- 68% of U.S. retailers stock CBD in 2023, up from 45% in 2020, NRF data
- CBD investment reached $15 billion globally in 2022, per PitchBook
- Female consumers 60% of CBD market, prefer wellness products, 2021 Nielsen
- Millennial usage at 35%, Gen Z 28% of CBD consumers in 2023 U.S. survey
- Hemp CBD production in U.S.: 500,000 acres planted in 2022, yield 1,200 lbs/acre
Market Statistics Interpretation
Pharmacological Properties
- CBD bioavailability is 6-15% for oral capsules, improving to 31-56% with lipid formulations in fasted state, per 2017 PK study (n=8)
- CBD half-life averages 18-32 hours after 10mg/kg oral dose in epilepsy patients
- CBD inhibits CYP3A4 with Ki=1.5μM and CYP2C19 with Ki=0.8μM in vitro human liver microsomes
- Sublingual CBD Cmax 133ng/mL at 19.5mg dose, Tmax 1.25-3 hours, bioavailability ~13-19%, 2010 study
- Inhaled CBD reaches plasma peak in 3-10 minutes, bioavailability 31%, versus 6% oral, per 2018 review
- CBD binds CB1 receptor with Ki=4350nM, partial agonist at 5HT1A with Ki=17nM
- Topical CBD penetrates stratum corneum to 20% dermis depth at 1% concentration in 24 hours ex vivo
- CBD induces CYP1A2 but inhibits CYP2D6 moderately (IC50=21μM) in hepatocytes
- Nanoemulsion CBD bioavailability 4x higher (34%) than oil (9%) at 10mg/kg oral in dogs, human-relevant
- Steady-state plasma CBD 747ng/mL at 20mg/kg/day oral in children, linear PK up to 10mg/kg BID
- CBD displaces [3H]CP55940 from CB1 with IC50=80nM but negligible functional agonism
- Transdermal CBD flux 0.6μg/cm²/h with enhancer, steady-state 4-6 hours in rat skin model
- CBD modulates GPR55 with EC50=0.7μM as antagonist in calcium assays
- Oral CBD Vd/F 26,487L, CL/F 1,129mL/min in adults, t1/2 60 hours accumulation factor 5.6
- CBD agitates TRPV1 at EC50=3.7μM, mediating analgesia in patch-clamp studies
- Intranasal CBD bioavailability 34-46% in sheep model, Tmax 6-10min
- CBD 7-OH metabolite active, AUC 10% parent after oral 20mg/kg, CYP2C19/3A4 dependent
- Microneedle patch CBD delivery 5x permeation vs passive (1.2μg/cm²/h)
- CBD allosterically modulates δ-opioid receptor enhancing [3H]leorphine binding
- Food effect: high-fat meal increases CBD AUC 4-5x, Cmax 14x at 10mg dose
- Vaporized CBD 100mg yields plasma Cmax 124ng/mL at 0.083h in smokers
- CBD equilibrates BBB rapidly, brain:plasma ratio 18.5:1 at 30min IV 120mg/kg in rats
- Self-emulsifying CBD formulation bioavailability 21% vs 6% oil at 10mg in humans (n=12)
- Inverse agonism at GPR18 with Ki=334nM for CBD in [35S]GTPγS assay
- Rectal CBD suppository bioavailability ~15%, Tmax 1.5-2h in PK study (n=10)
Pharmacological Properties Interpretation
Side Effects
- Common side effect of oral CBD is somnolence, occurring in 21% of patients at 20mg/kg/day in Epidiolex trials with 516 participants
- Diarrhea reported in 20% of CBD users at doses >10mg/kg/day versus 10% placebo in a 2019 epilepsy study of 199 patients
- Decreased appetite seen in 16% of pediatric epilepsy patients on 10mg/kg CBD twice daily over 48 weeks
- Elevated liver enzymes (ALT >3x ULN) in 11% of adults on 20mg/kg/day CBD versus 4% placebo in 14-week trial
- Fatigue occurred in 13% of 225 Lennox-Gastaut patients on Epidiolex 20mg/kg/day in Phase 3 study
- A 2021 survey of 1,281 CBD users found dry mouth in 15% and dizziness in 9% at average 25mg/day doses
- Drug interactions: CBD increased plasma levels of clobazam by 3-fold at 10mg/kg/day in 13 patients
- Nausea reported in 9% of healthy volunteers taking 1500mg single dose CBD in pharmacokinetic study
- In 2020 study, 600mg CBD caused mild hypotension in 12% of 32 stress-tested subjects
- Pruritus (itching) in 7% of topical CBD users (1% cream) in 2019 dermatology trial with 50 patients
- A 2018 review noted thrombocytopenia in 5% of long-term CBD users >1000mg/day
- Sedation increased by 18% with CBD + THC versus THC alone in 24 chronic pain patients
- In 2022, 8% of 400 surveyed users reported anxiety paradoxically at low doses (<10mg)
- CBD at 100mg vaporized caused cough in 11% of 30 naive users in acute study
- Weight loss of >5% bodyweight in 6% of epilepsy patients on high-dose CBD over 1 year
- Rash occurred in 4% of pediatric patients on Epidiolex in expanded access program (n=117)
- A 2021 PK study showed CBD inhibits CYP2C19, raising nortriptyline levels 2.5x in 12 subjects
- Insomnia rebound in 10% upon CBD discontinuation after 4 weeks at 160mg/night
- In 2019, 14% of 397 epilepsy patients had pyrexia on CBD therapy
- Elevated GGT in 7% of long-term users (48 weeks) at 20mg/kg/day
- Irritability in 5% of autism children on 25mg/kg CBD after 12 weeks
- Palpitations rare (2%) but noted in high-dose (1500mg) single administration trials
- A 2020 survey (n=2,701) reported 3% GI upset with oral CBD oils averaging 50mg/day
- Contact dermatitis in 3% from transdermal CBD patches in 2018 study (n=100)
- CBD use linked to 4% increase in suicidal ideation in schizophrenia adjunct trial (n=43)
- Ataxia in 6% of Dravet patients on Epidiolex Phase 3 (n=67)
Side Effects Interpretation
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