CHI-902 for Treatment of Social Anxiety Disorder
Social Anxiety Disorder
About this trial
This is an interventional treatment trial for Social Anxiety Disorder focused on measuring Anxiety, Cannabis, Cannabidiol, CBD
Eligibility Criteria
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:
- Meet DSM-5 criteria for SAD
- Score >60 on the Liebowitz Social Anxiety Scale (LSAS)
Exclusion Criteria:
- 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;
- Past or current neurological illness or head trauma;
- History of bipolar disorder, psychotic disorder/schizophrenia, schizoaffective disorder, obsessive-compulsive disorder, or personality disorder (Cluster A or B);
- 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;
- Current psychotic symptoms;
- Current suicidal ideation or suicide attempt or self-harm behavior in the past year;
- Current unstable psychiatric condition;
- Substance use disorder in the past 6 months except nicotine
- 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;
- Regular pharmacological treatment with psychotropic medications except benzodiazepines which may be used as a rescue medication
- 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;
- Pregnancy or lactation;
- 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;
- Positive urine during drug screening for drugs of abuse (except benzodiazepines);
- Reported history of difficulty with intravenous blood draws;
- Allergy to or intolerability of cannabinoids, CBD or other ingredients of the product;
- Baseline liver, renal, or hematological laboratory abnormalities.
Sites / Locations
- MacAnxiety Research Center, McMaster University
- Centre for Addiction and Mental Health (CAMH)
Arms of the Study
Arm 1
Arm 2
Active Comparator
Placebo Comparator
CHI-902
Placebo
Study subjects will enter a titration phase of 1 week with a daily oral CBD dose of 150 mg (50 mg three times daily). Then, daily CBD dose of 300 mg or matching placebo will be given for 3 weeks (treatment phase 1; fixed dose).
Study subjects will enter a titration phase of 1 week with a daily oral dose of 150 mg (50 mg three times daily) of matching placebo. Then, daily dose of 300 mg of matching placebo will be given for 3 weeks (treatment phase 1; fixed dose).