Status:
WITHDRAWN
CHI-902 for Treatment of Social Anxiety Disorder
Lead Sponsor:
Canopy Growth Corporation
Collaborating Sponsors:
Centre for Addiction and Mental Health
McMaster University
Conditions:
Social Anxiety Disorder
Eligibility:
All Genders
18+ years
Phase:
PHASE2
Brief Summary
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 evalu...
Detailed Description
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 ...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
January 24 2020
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
January 26 2021
Estimated Enrollment :
Patients enrolled
Trial Details
Trial ID
NCT04086342
Start Date
January 24 2020
End Date
January 26 2021
Last Update
June 4 2020
Active Locations (2)
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1
MacAnxiety Research Center, McMaster University
Hamilton, Ontario, Canada, L8S 1B8
2
Centre for Addiction and Mental Health (CAMH)
Toronto, Ontario, Canada