Summary of Clinical Dosing for
Study Title Key Findings Route Dose Year
Short-Term Cannabidiol with Δ-9-Tetrahydrocannabinol in Parkinson's Disease: A Randomized Trial In subjects with Parkinson's disease, there was no benefit to high cannabidiol (CBD)/low Δ-9-tetrahydrocannabinol (THC) versus placebo. Additionally, there was perhaps worsened cognition and sleep, and many mild adverse events. Oral (Ingestion)

CLINICAL TRIAL

Study Dosing Objective:  Effective Dose, Safety Profile

Established Protocol:  No effective dose

Cannabinoid Ratio:  (CBD : THC)   191 : 6

Dosage Form:  cannabis extract (National Institute of Drug Abuse) oral sesame oil solution (100 mg/mL CBD and 3.3 mg/mL THC)

Dosing Regimen:  1.25 mg/kg/day each morning (~1 mL) for 4 ± 1 days and then twice daily for 14 ± 4 days Mean final dose (CBD/THC group) was 191.8 ± 48.9 mg CBD and 6.4 ± 1.6 mg THC daily

Maximum Dose:  2.5 mg/kg/day

Treatment Duration:  2 weeks

Clinical Relevance:  CBD/THC did not improve symptoms of Parkinson's disease and may have worsened some, especially cognition.

Adverse Events:  More common in the CBD-THC group: dizziness, cognitive adverse effects, pneumonia

2024
Oral Cannabidiol for Seborrheic Dermatitis in Patients With Parkinson Disease: Randomized Clinical Trial There was no solid evidence in this study that oral cannabidiol therapy reduces the presence of seborrheic dermatitis among this sample of patients with Parkinson's disease. Oral (Ingestion)

CLINICAL TRIAL

Study Dosing Objective:  Effective Dose, Safety Profile,

Established Protocol:  No effective dose

Cannabinoid Ratio:  (CBD : THC)   100 : 3

Dosage Form:  2.5 mg per kg per day oral sesame solution CBD-rich cannabis extract (formulated to 100 mg/mL CBD and 3.3 mg/mL THC)

Dosing Regimen:  1.25 mg per kg per day each morning for 4 ±1 days and then twice daily for 10 ±4 days

Treatment Duration:  16 days

Clinical Relevance:  There was no solid evidence in this study that oral cannabidiol therapy reduces the presence of seborrheic dermatitis among this sample of patients with Parkinson's disease.

Adverse Events:  no notable changes in blood laboratory studies, including liver tests no unexpected and serious adverse effects no significant dermatological adverse events

2024
Cannabidiol and cognitive functions/inflammatory markers in Parkinson's disease: A double-blind randomized controlled trial at Buriram Hospital (CBD-PD-BRH trial) Compared to placebo, sublingual cannabidiol (CBD) was safe, with no adverse effects on motor, cognitive, or affective symptoms in patients with Parkinson's disease (PD), and improved the Montreal Cognitive Assessment (MoCA) naming scores. Sublingual/Oromucosal

CLINICAL TRIAL

Study Dosing Objective:  Safety Profile,

Cannabinoid Ratio:  (CBD : THC)   102 : 5

Dosage Form:  sublingual CBD-enriched product (101.9 mg/ml CBD, 4.8 mg/ml tetrahydrocannabinol [THC])

Dosing Range:  mean CBD dose was 26 mg/day, and THC was 1.2 mg/day

Treatment Duration:  12 weeks

Clinical Relevance:  Compared to placebo, sublingual cannabidiol (CBD) was safe for patients with Parkinson's disease (PD), and improved the Montreal Cognitive Assessment (MoCA) naming scores.

Adverse Events:  No adverse effects on motor, cognitive, or affective symptoms.

2024
A Phase Ib, Double Blind, Randomized Study of Cannabis Oil for Pain in Parkinson's Disease In subjects with Parkinson's Disease, mixed formulations of THC/CBD were tolerated with no serious adverse effects, and should be considered for further trials as an adjuvant treatment option. Oral (Ingestion)

CLINICAL TRIAL

Study Dosing Objective:  Effective Dose, Safety Profile,

Established Protocol:  Maximum tolerated dose

Cannabinoid Ratio:  (THC : CBD)   18 : 20

Dosing Regimen:  THC/CBD (18:0, 10:10, and 1:20)

Clinical Relevance:  In subjects with Parkinson's Disease, mixed formulations of THC/CBD were tolerated with no serious adverse effects and should be considered for further trials as an adjuvant treatment option.

Adverse Events:  no serious AE, most common AE were drowsiness and dizziness (three participants) sleepiness scale scores were higher in the high CBD formulation

Additional Notes:  Clinical Trial Phase I, Parallel Dose Comparison

2023
Cognitive Safety Data from a Randomized, Double-Blind, Parallel-Group, Placebo-Controlled Phase IIb Study of the Effects of a Cannabidiol and Δ9-Tetrahydrocannabinol Drug on Parkinson's Disease-Related Motor Symptoms Subjects given high-dose oral cannabidiol and low-dose oral Δ9-tetrahydrocannabinol performed worse than the placebo group on Animal Verbal Fluency and reported adverse cognitive events at least twice as often as the placebo group. Oral (Ingestion)

CLINICAL TRIAL

Study Dosing Objective:  Effective Dose,

Established Protocol:  No effective dose

Cannabinoid Ratio:  (CBD : THC)   100 : 3

Dosage Form:  a frozen extract CBD 100 mg/mL and THC 3.3 mg/mL sesame oil solution

Dosing Regimen:  high-dose cannabidiol 100 mg low-dose Δ9-tetrahydrocannabinol 3.3 mg

Starting Dose:  started at 1.25 mg/kg/day daily for 4 ± 1 days

Titration:  increased to 1.25 mg/kg/day twice daily (minimum 6 hours apart) for 14 ± 4 days, and adjusted as needed for tolerability

Adverse Events:  Mild adverse cognitive events

2023
Cannabidiol-enriched cannabis extraction product in Parkinson's disease: A randomized, double-blind, and placebo-controlled trial in Buriram Hospital In patients with Parkinson's disease (PD) cannabidiol-enriched cannabis extraction product (CBDEP) was no more effective than placebo in reducing disease severity or improving functional performance, anxiety, or depression. CBDEP was however safe and improved the levels of BUN, serum albumin, serum globulin, and albumin/globulin ratio likely due to agonizing the CB2 receptor.

CLINICAL TRIAL

Study Dosing Objective:  Effective Dose, Safety Profile,

Established Protocol:  Effective dose

Cannabinoid Ratio:  (CBD : THC)   100 : 4

Dosage Form:  Charlotte’s Angel strain of cannabis using an ethanol extraction technique and dissolved in olive oil, containing 100 mg/mL cannabidiol and 3.9 mg/mL tetrahydrocannabinol

Dosing Regimen:  CBD 15.59 mg:THC 0.61 mg per day

Starting Dose:  started with a very low dose

Titration:  gradually up-titrated through telephonic instruction every 3–5 days for 2 weeks followed by 6 weeks of stable dosing

Dosing Range:  mean cannabidiol and tetrahydrocannabinol dosages of 15.59 ± 5.04 and 0.61 ± 0.19 mg/day

Treatment Duration:  8 weeks

Clinical Relevance:  There was a significant link between a cannabidiol dosage and improvement in the levels of BUN, serum albumin, serum globulin, and the albumin/globulin ratio in Parkinson's disease likely due to agonizing the CB2 receptor.

Adverse Events:  All adverse events were mild and well tolerated: Dry throat, mild gastrointestinal disturbance No serious adverse event was observed in either group.

Additional Notes:  Dose Titration

2023
Eye Tracking in Patients with Parkinson's Disease Treated with Nabilone-Results of a Phase II, Placebo-Controlled, Double-Blind, Parallel-Group Pilot Study This secondary analysis found that nabilone did not worsen ocular motility or saccadic inhibitory control in subjects with Parkinson's disease and did not significantly worsen cognitive performance, suggesting its safety in this patient population. Oral (Ingestion)

CLINICAL TRIAL

Study Dosing Objective:  Safety Profile,

Cannabinoid Ratio:  (THC only)  

Dosage Form:  nabilone

Starting Dose:  0.25 milligrams (mg) in the evening

Titration:  titrated in 0.25-mg increments once or twice daily

Maximum Dose:  1 mg twice daily

Treatment Duration:  4 weeks

Clinical Relevance:  There were no significant group differences between the placebo and the nabilone groups in the reaction times of the other saccadic paradigms.

Additional Notes:  Dose Titration

2022
The Effect of Cannabidiol for Restless Legs Syndrome/Willis-Ekbom Disease in Parkinson's Disease Patients with REM Sleep Behavior Disorder: A Post Hoc Exploratory Analysis of Phase 2/3 Clinical Trial This post hoc exploratory analysis of a previously concluded phase II/III double-blind, placebo-controlled clinical trial of patients with both Parkinson's disease (PD) and REM (Rapid Eye Movement) sleep behavior disorder (RBD) who took cannabidiol (CBD) for Restless Legs Syndrome (RLS). Results show CBD did not improve RLS severity in this population. Oral (Ingestion)

CLINICAL TRIAL

Study Dosing Objective:  Effective Dose

Established Protocol:  No effective dose

Cannabinoid Ratio:  (CBD only)  

Dosing Regimen:  CBD (75-300 mg)

Treatment Duration:  14 weeks

Clinical Relevance:  CBD did not reduce the severity of Restless Legs Syndrome/Willis-Ekbom Disease (RLS/WED) in patients with Parkinson's disease.

Additional Notes:  Clinical Trial Phase II, Clinical Trial Phase III

2022
Non-Motor Symptoms in Parkinson's Disease are Reduced by Nabilone Nabilone, a synthetic tetrahydrocannabinol (THC) drug, was effective in improving non-motor symptoms, mood, and sleep in patients with Parkinson's disease. Treatment was overall safe and well tolerated, despite reports of adverse effects in 75% of subjects, though most were mild. Oral (Ingestion)

CLINICAL TRIAL

Study Dosing Objective:  Effective Dose, Safety Profile

Established Protocol:  Effective dose

Cannabinoid Ratio:  (THC only)  

Dosage Form:  Nabilone

Dosing Regimen:  Nabilone (median dose = 0.75 mg)

Dosing Range:  0.25 mg - 2 mg per day

Treatment Duration:  4 weeks

Clinical Relevance:  Nabilone is potentially effective in reducing non-motor symptoms in patients with Parkinson's Disease and appears to be driven by positive effects on anxiety, mood, and sleep problems.

Adverse Events:  No severe AE (SAE), suspected unexpected serious adverse reaction, or suicidality (C-SSRS) occurred in any patient during the study and follow-up period.

Additional Notes:  Clinical Trial Phase II

2020
Effects of acute cannabidiol administration on anxiety and tremors induced by a Simulated Public Speaking Test in patients with Parkinson's disease Acute CBD administration at a dose of 300 mg decreased anxiety in patients with PD, and there was also decreased tremor amplitude in an anxiogenic situation.

CLINICAL TRIAL

Study Dosing Objective:  Effective Dose

Established Protocol:  Effective dose

Cannabinoid Ratio:  (CBD only)  

Dosing Regimen:  CBD (300 mg)

Treatment Duration:  one dose

Clinical Relevance:  CBD decreased anxiety and tremor amplitude in an anxiogenic situation in patients with Parkinson's Disease.

Additional Notes:  Cross-Over

2020
Ultra-micronized Palmitoylethanolamide: An Efficacious Adjuvant Therapy for Parkinson's Disease This study concludes that palmitoylethanolamide (PEA) reduced motor and non-motor symptoms as well as slowed the rate of decline and disability in patients with Parkinson's disease (PD) and supports further research on PEA as an add-on option for patients. Oral (Ingestion)

CLINICAL TRIAL

Study Dosing Objective:  Effective Dose

Established Protocol:  Effective dose

Dosage Form:  Ultra-micronized Palmitoylethanolamide (600 mg)

Clinical Relevance:  Ultra-micronized palmitoylethanolamide (um-PEA) slowed down disease progression and disability in Parkinson's Disease (PD) patients and may be an effective adjuvant therapy.

2017
Effects of cannabidiol in the treatment of patients with Parkinson's disease: an exploratory double-blind trial Findings point to a possible effect of CBD in improving quality of life measures in PD patients with no psychiatric comorbidities; however, studies with larger samples and specific objectives are required before definitive conclusions can be drawn.

CLINICAL TRIAL

Study Dosing Objective:  Effective Dose

Established Protocol:  No effective dose

Cannabinoid Ratio:  (CBD only)  

Dosage Form:  CBD

Dosing Regimen:  Three study groups: CBD (75 mg/day), CBD (300 mg/day), or placebo

Dosing Range:  75-300 mg/day

Clinical Relevance:  The results point to a possible effect of CBD in improving quality of life measures in PD patients without psychiatric comorbidities.

2014