CHI-902 for Treatment of Social Anxiety Disorder

CHI-902 for Treatment of Social Anxiety Disorder - A Phase IIb Randomized Double-Blind Placebo-Controlled Clinical Trial

No substantial clinical trials of Cannabidiol (CBD) in Social Anxiety Disorder (SAD) have yet been conducted. This randomized doubleblind, placebo-controlled trial of CBD in adults with SAD will evaluate the efficacy, tolerability and safety of CBD oil (CHI-902) in SAD. In addition, the effects of treatment with CHI-902 on the Endocannabinoid System (ECS) will be assessed by evaluating peripheral endocannabinoids (Arachidonoylethanolamide/Anandamide (AEA) and 2-Arachidonoyl glycerol (2-AG)) before and after treatment.

This study will evaluate efficacy, therapeutic effects, tolerability and safety of CBD oil in adults with SAD through a randomized placebo-controlled study design and will evaluate effects of CHI-902 on peripheral endocannabinoids (AEA and 2-AG). This study will be the first randomized, double-blind placebo-controlled trial conducted with CHI-902 in adults with SAD.

The study is designed to:

• Evaluate the efficacy of CHI-902 versus placebo in adults with SAD.
• Evaluate the tolerability and safety versus placebo of CHI-902 in adults with SAD.
• Explore the effects of CHI-902 versus placebo on different biomarkers in subjects with SAD.

Inclusion Criteria: Adult males or females (≥18 years of age) will be enrolled until the required number of n=160 subjects completing all study procedures is met. Individuals will be included if they:

1. Meet DSM-5 criteria for SAD
2. Score >60 on the Liebowitz Social Anxiety Scale (LSAS)

Exclusion Criteria:

1. Serious, unstable medical condition including but not limited to cerebrovascular, renal, hepatic, coronary heart disease, coagulation/blood disorders, use of anticoagulant medication, pre-existing cardiovascular disease including poorly controlled hypertension, ischaemic heart disease, arrhythmia, or heart failure;
2. Past or current neurological illness or head trauma;
3. History of bipolar disorder, psychotic disorder/schizophrenia, schizoaffective disorder, obsessive-compulsive disorder, or personality disorder (Cluster A or B);
4. Current moderate or severe major depressive episode, panic disorder, generalized anxiety disorder, or post-traumatic stress disorder (PTSD). Traits associated with these disorders are permissible but full DSM criteria should not be met;
5. Current psychotic symptoms;
6. Current suicidal ideation or suicide attempt or self-harm behavior in the past year;
7. Current unstable psychiatric condition;
8. Substance use disorder in the past 6 months except nicotine
9. Cannabis use or use of medications or drugs targeting endocannabinoid system including but not limited to nabiximols, nabilone, or synthetic cannabinoids in the past 3 months;
10. Regular pharmacological treatment with psychotropic medications except benzodiazepines which may be used as a rescue medication
11. Pharmacological treatment with medications with potential significant drug-drug interactions with CBD through Cytochrome P450 metabolization (CYP3A4, CYP2C9, CYP2C19, CYP1A1) based on the Investigator assessment;
12. Pregnancy or lactation;
13. Males and females of child-bearing potential must be using and willing to continue using medically acceptable contraception throughout the study to avoid pregnancy during the study and for up to 4 weeks after study completion, as described below. Study-acceptable methods of birth control are double-barrier methods, which include a combination of any 2 of the following: oral contraceptives, diaphragm, condom, copper intrauterine device, sponge, spermicide, or (partner's) vasectomy;
14. Positive urine during drug screening for drugs of abuse (except benzodiazepines);
15. Reported history of difficulty with intravenous blood draws;
16. Allergy to or intolerability of cannabinoids, CBD or other ingredients of the product;
17. Baseline liver, renal, or hematological laboratory abnormalities.