Evaluation of the efficacy, safety, and pharmacokinetics of nanodispersible cannabidiol oral solution (150 mg/mL) versus placebo in mild to moderate anxiety subjects: A double blind multicenter randomized clinical trial
Prasad Rao Gundugurti a 1 , Nagaraju Banda b , Siva Sankara Rao Yadlapalli b , Arjun Narala b , Ramyasree Thatikonda b , Chandrashekhar Kocherlakota b 2 , Kumar SD Kothapalli c 3
a
Asha Hospital, 443, Venkat Nagar, Banjara Hills, Hyderabad, Telangana 500034, India
b
Leiutis Pharmaceuticals LLP, Plot No. 23, TIE 1st Phase, Balanagar, Hyderabad, Telangana 500037, India
c
Biophore Pharma Inc, 4262 US-1 Suite A, Monmouth Junction, NJ 08852, USA
Affiliationer
Background
Anxiety disorders, an increasingly prevalent global mental health illness, affected approximately 301 million individuals worldwide in 2019. There is an unmet need for the treatment of anxiety disorders, as current therapies are associated with limited response rates, residual symptoms, and adverse effects.
Objectives
To evaluate the efficacy, safety, and pharmacokinetics of nanodispersible cannabidiol (CBD) oral solution versus placebo for the treatment of mild to moderate anxiety disorders.
Methods
This phase 3 prospective, randomized, double blind, parallel group, placebo-controlled, 15-week cohort study took place at multiple sites across India. Eligible participants were randomly assigned to one of the two treatment arms (CBD or placebo) in a 1:1 ratio.
Results
178 participants were randomized to receive CBD (n=89) or placebo (n=89). The study met both primary (GAD-7 and HAM-A scores) and secondary outcomes (CGI-I, CGI-S, PHQ-9 and PSQI scores). The GAD-7 score difference between the end of treatment and baseline for the CBD versus the placebo was −7.02 (S.E: 0.25, 95% CI −7.52; −6.52), p<0.0001. Similarly, the HAM-A score difference at the end of treatment compared to baseline for the CBD versus the placebo was −11.9 (S.E: 0.33, 95% CI −12.6; −11.3), p<0.0001.
Conclusions
Nanodispersible CBD was therapeutically safe with no serious adverse events, well tolerated, and effective for the treatment of mild to moderate anxiety disorders, as well as associated depression and sleep quality disturbances. These results pave way for probable prospective use of nanodispersible CBD formulation for various psychiatry disorders alone or in conjunction with other drugs.
