Table 2 Clinical trials on the effect of CBD treatment on AD
CT registration No | Study title | Status (Apr.2024) | Study completion (actual or estimated) | Study type/design | Number of participants (actual or estimated) | AD type/symptoms | CBD Treatment | Treatment duration | Reference link |
|---|---|---|---|---|---|---|---|---|---|
Completed trials | |||||||||
 NCT05003882 | Radicle ACES: A study of commercially available CBD used in the real-world setting | completed, no results posted | 31-Dec-21 | 13-arm, real-world, open-label study | 3000 | anxiety, pain, sleep disturbance | 12 different commercial CBD extracts | 4 weeks | |
 NCT05108220 | Evaluation of effects of CBD products among US women | completed, no results posted | 30-Dec-20 | retrospective, observational study | nine groups, 150 female participants each (total, N = 1350) | GAD in women | 8 different CBD products, 15 to 30 mg/day | 8 weeks | |
 NCT05253417 | The CANabidiol Use for RElief of Short-Term insomnia (CANREST) | completed, no results posted | 07-Jul-23 | double-blind, randomized, parallel-group, placebo-controlled study | 208 | Insomnia due to anxiety and fear, and other forms of insomnia | oral capsule, 50 or 100 mg per day | 8 weeks | |
 NCT02818777 | A study of the tolerability and efficacy of cannabidiol on tremor in Parkinson’s disease | completed, results posted | Nov-17 | open-label, single-group assignment | 13 | Focus on Parkinson's disease symptoms, an anxiety questionnaire was included (no CBD effects on AD reported) | Epidiolex®, started at 5 mg/kg/day, increased up to 20 mg/kg/day | 5 weeks | |
 NCT03582137 | A study of tolerability and efficacy of cannabidiol on motor symptoms in Parkinson´s disease | completed, results posted | 04-Jan-22 | randomized, double-blind, placebo-controlled (parallel group) design, Phase 2 | 74 | Focus on Parkinson's disease symptoms, an anxiety questionnaire was included (no CBD effects on AD reported) | CBD extract (oral) or placebo, titrated up to 2.5 mg/kg/day | 2–3 weeks | |
 NCT05023759 | Anxiety symptoms in relation to use of hemp-derived, full-spectrum CBD | completed—no results posted | 31-Oct-20 | open-label, observational prospective study | 30 | GAD | oral capsules, full-spectrum CBD extract, 25 mg/day | 8 weeks | |
Currently ongoing trials | |||||||||
 NCT04482244 | RCT of CBD for anxiety in advanced breast cancer | active, not recruiting | 18-Dec-24 | randomized, double-blind, placebo-controlled Phase 2 trial of a single dose of CBD | 50 | Acute anticipatory anxiety in Advanced Breast Cancer patients | Epidiolex®, per protocol dosage | single acute dose | |
 NCT05600114 | Cannabidiol (CBD) for the Treatment of Social Anxiety Disorder | active, not recruiting | Dec-23 | multicenter, double-blind, parallel group, placebo-controlled, randomized phase 2 trial | 225 | SAD | oral solution, 300 or 600 mg/day | 10 weeks | |
 NCT05823753 | Cannabidiol to Reduce Anxiety Reactivity | recruiting | Apr-25 | Randomize, placebo-controlled 3-arm, sub-acute (4-day) steady state dosing phase 2 clinical trial | 60 | SAD | Epidiolex®, 300 mg/day or 900 mg/day | 4 days | |
 NCT05753007 | A Clinical Trial of a Hemp-Derived, High Cannabidiol Product for Anxiety in Glioblastoma Patients | recruiting | Sep-25 | double-blind, placebo-controlled, 8-week randomized phase 2 trial | 36 | Anxiety, pain, QOL in glioblastoma patients | Full-spectrum, hemp-derived, "ultra-high CBD" solution, dose not indicated | 8 weeks | |
 NCT06364254 | Effects of CBD on 2 Mile Run Time Trial Performance | recruiting | 30-May-24 | cross-over, placebo-controlled pilot study | 30 | pre-race anxiety and physical symptoms in running women | Oral capsule, 300 mg, 2 h prior to 2 mile run | single acute dose | |
 NCT03944447 | Outcomes Mandate National Integration With Cannabis as Medicine (OMNI-Can) | recruiting | 31-Dec-25 | multistate, multicenter clinical phase 2 study | 200,000 | variety of 33 chronic debilitating conditions including anxiety | medical cannabis (RYAH-Medtech Inhaler) dosing will be recommended depending on indication | 5 years or longer | |
 NCT05457465 | Assessing the Impact of Cannabidiol for Anxiety and Depression in Bipolar Disorder | recruiting | Jun-25 | open-label clinical phase 2 trial, pilot study | 25 | anxiety, depression in bipolar disorder patients | sublingual, hemp-derived, high-CBD product, daily dose not indicated | 4 weeks | |
 NCT05571592 | Cannabidiol as a Treatment for Social Anxiety Disorder (R61) | recruiting | 01-Aug-24 | double-blind randomized controlled phase 2 trial | 60 | SAD | softgel capsules with self-emulsifying nanoformulation: 400 mg/day or 800 mg/day | 3 weeks | |
 NCT04978428 | Epidiolex in obsessive compulsive disorder and related disorders | recruiting | 01-Sep-24 | open-label, single-group intervention trial (proof-of-concept) | 15 | Obsessive compulsive disorder and related disorders. Anxiety not explicitly included | Epidiolex® (2.5 mg/kg b.i.d for one week followed by 5 mg/kg b.i.d.) for two total weeks | 3 weeks | |
 NCT03948074 | Cannabis For Cancer-Related Symptoms (CAFCARS) | recruiting | 01-Mar-24 | randomized, double-blind, placebo-controlled phase 2 study | 150 | Anxiety, nausea, pain, sleep disturbance in cancer patients | 3 different Cannabis oil extracts: High THC/Low CBD, Low THC/High CBD, and 1:1 THC/CBD, titrated for up to 18 drops/day (dose not indicated) | 1 to 4 cycles of 16 days each | |
 NCT03549819 | Cannabidiol for the Treatment of Anxiety Disorders: An 8-Week Pilot Study | recruiting | Feb-24 | randomized, triple-blind, phase 3 trial that uses a parallel assignment model, implying a two-arm trial (CBD or placebo) | 50 | GAD, SAD, panic disorder, and agoraphobia | CBD oral capsules, 200 to 800 mg/day | 8 weeks | |
 NCT02548559 | Sublingual CBD for anxiety disorders | recruiting | Aug-25 | randomized, open-label to double-blind, placebo-controlled phase 1/2 study | approx. 100 | various AD, not specified | CBD full spectrum extract or pure CBD, sublingual; 30 mg/day | 4 weeks | |
 NCT04075435 | Cannabidiol solution for the treatment of behavioral symptoms in older adults with Alzheimer’s disorder | recruiting | 15-Sep-24 | single-group assignment open-label phase 1 study | 12 | anxiety in Alzheimer Disease patients | high CBD/low THC sublingual solution, variable dosing | 8 weeks | |
 NCT05324449 | Epidiolex® for anxiety in pediatric epilepsy | recruiting | 04-Apr-26 | open label, adjunctive, proof of concept, prospective phase 4 clinical trial | 20 | anxiety secondary to refractory pediatric epilepsy | Epidiolex®, flexible dose titration; adjunct to anticonvulsive treatment | 16 weeks | |
 NCT02283281 | Anesthetic premedication with cannabis extracts (Cannapremed) | recruiting | Dec-24 | randomized, placebo-controlled (parallel assignment with three arms) phase 2/3 trial | 200 | Perioperative Anxiety, postoperative pain, nausea & vomiting | Cannabis oil, intravenous, single dose (21.6 mg THC + 20 mg CBD) or (10.8 mg THC + 10 mg CBD) | single acute dose | |
 NCT04878627 | Role of CBD in regulating meal-time anxiety in anorexia nervosa | recruiting | Oct-24 | double-blind, placebo-controlled (parallel assignment) phase 1 study | 40 | Anxiety in anorexia nervosa patients | Epidiolex®, dose titration from2.5 mg/kg to 7.5 mg/kg | 3 weeks | |
 NCT05283382 | Cannabidiol effects on learning and anxiety | not yet recruiting | Feb-25 | randomized, double-blind, placebo-controlled trial with two-by-two factorial assignment | 160 | healthy volunteers who display elevated social anxiety | one 600 mg CBD Isolate Gel Capsule | single acute dose | |
 NCT06290063 | Cannabidiol and Older Adult Cannabis Users (QUARTz) | not yet recruiting | 31-Aug-28 | 3-arm randomized, placebo- controlled phase 2 trial | 385 | anxiety in older individuals who seek to use cannabis | oral capsules, full-spectrum (200 mg CBD, 4 mg THC) or broad spectrum (200 mg CBD, 0 mg THC) CBD capsules, 200 mg/day | 8 weeks | |
 NCT06266611 | Cannabis for Palliative Care in Cancer (ARCTiC) | not yet recruiting | 31-Jul-28 | 3-arm, placebo-controlled randomized phase 2 trial | 185 | Anxiety and other symptoms in palliative cancer patients | oral capsules, full-spectrum (200 mg CBD, 4 mg THC) or broad spectrum (200 mg CBD, 0 mg THC) CBD capsules, 200 mg/day | 8 weeks | |
 NCT06123702 | Cannabidiol Effects on Fear Extinction in Social Phobia | not yet recruiting | 30-Sep-24 | double-blind, randomized controlled phase 1 trial | 20 | SAD | oral capsules, 600 mg/day | single acute dose | |
 NCT05649059 | Investigating the Effects of Cannabidiol on Social Anxiety Disorder | not yet recruiting | May-25 | randomized, double-blind, placebo-controlled, parallel-group phase 4 trial | 50 | SAD | Epidiolex®, 300 mg | single acute dose | |
 NCT06261502 | Effect of CANnabidiol on Anxiety and GABAergic Function in Individuals With Fragile-X Syndrome (CANAX) | not yet recruiting | Aug-27 | Randomized, double-blind, placebo-controlled, single center, cross-over phase 2 trial | 40 | Anxiety, GABAergic function in Fragile X patients | Oral solution (Epidiolex®?), escalating from 5 mg/kg/day to 10 mg/kg/day | 2 × 12 weeks, 8-week washout | |
Abandoned trials | |||||||||
 NCT05429788 | Safety, tolerability, and efficacy of RLS103 in subjects with acute anxiety with social anxiety disorder | Withdrawn | 08-Nov-22 | randomized, double-blind, placebo-controlled (parallel assignment) phase 1b/2a trial | 30 | SAD | CBD inhalation powder (RLS103), 3 mg or 6 mg CBD per administration | single acute dose | |
 NCT04267679 | Cannabidiol for anxiety | withdrawn | 01-Dec-20 | single-group assignment, open-label phase 2 trial (pilot) | not indicated | GAD | full-spectrum CBD soft gel capsules, up to 100 mg/day | 12 weeks | |
 NCT04286594 | A clinical trial of hemp-derived CBD product for anxiety | terminated by sponsor | 24-Aug-23 | Phase 2 randomized open-label to double-blind study | 12 | Anxiety (not specified) | sublingual CBD solution (hemp extract), 30 mg/day | 6 weeks | |
 NCT04726475 | Impact of CBD-rich oil on aversive memory reconsolidation | Unknown status | Jan-24 | three-arm, proof-of-concept double-blind, placebo-controlled trial phase 1/2 trial | 96 | PTSD (anxiety & fear) | CBD-rich hemp extract oil, acute dose 300 mg | two single doses | |
 NCT04729244 | The study of hemp oil CBD for evaluation of efficacy and safety in treatment of pain, anxiety, and insomnia management | Unknown status | 01-Feb-22 | non-randomized, open-label pilot study | 30 | Chronic pain, anxiety and insomnia | CBD tincture or cream, 50 mg/day | 4 weeks | |
 NCT04569760 | Cannabidiol for the treatment of anxiety disorders: an 8-week pilot study | withdrawn | Jun-23 | randomized, double-blind, placebo-controlled parallel design, phase 3 (pilot study) | 50 | GAD, SAD, panic disorder, and agoraphobia | 50:2 mg(CBD:THC)/ml—Cannabinoid Oil Oral Preparation; titrated (200 mg- 800 mg total CBD dose) | 8 weeks | |
 NCT04086342 | CHI-902 for treatment of social anxiety disorder | withdrawn | 26-Jan-21 | randomized double-blind, placebo-controlled phase 2 trial | 160 | SAD | CBD extract in MCT oil; titration from 150 to 300 mg/day | 4 weeks | |