Cannabidiol to Reduce Anxiety Reactivity
Social Anxiety, Social Anxiety Disorder
About this trial
This is an interventional treatment trial for Social Anxiety focused on measuring Cannabidiol (CBD), Social Anxiety
Eligibility Criteria
Inclusion criteria: (1) Principal diagnosis of social anxiety disorder (SAD) according to the Mini-International Neuropsychiatric Interview for DSM-5 (MINI Version 7.0.2; Sheehan, 2016); (2) clinician-administered LSAS score ≥ 60 and score ≥ 2 on Question 6 (public speaking fear/anxiety sub-scale; Mennin et al., 2002); (3) ages 18-70; (4) able to provide informed, written consent; (5) English proficiency. Exclusion criteria are included to ensure that participation does not place subjects at undue risk, and to minimize confounding interpretation of our findings: Current or imminent risk of suicide assessed using the Columbia Suicide Severity Rating Scale (C-SSRS) Bipolar or psychotic disorders History of major neurological disorder or moderate to severe traumatic brain injury or severe or unstable medical conditions that might be compromised by participation in the study. Past 6-month substance use disorder (any severity, with the exception of mild alcohol use disorder) Prior history of cannabis use disorder, or allergy or intolerance to cannabinoids Current (within past 7 days) cannabinoid use (medicinal or recreational; assessed using patient report and a urine sample). Concurrent cannabinoid use is prohibited during the study. Positive urinalysis screen for psychoactive drug use (that is not physician prescribed) Abnormal and clinically relevant blood count, liver, renal or EKG findings as determined by physician Currently prescribed medications with known CBD-interactions (e.g., amiodarone, fluconazole, metronidazole, miconazole, sulfamethoxazole, clarithromycin, erythromycin, cyclosporine, verapamil, itraconazole, voriconazole, boceprevir, St. John's Wart, and carbamazepine) People who are pregnant, breastfeeding, or planning to become pregnant within the next 6 months. People who are able to get pregnant who do not meet those exclusions must agree to use an acceptable method of contraception from at least 21 days prior to the first dose of study drug and for 3 months after the last dose of study drug for study entry. Concurrent empirically supported psychosocial treatments for anxiety or mood disorders (e.g., cognitive behavioral therapy) Use of any psychotropic medication (e.g. SSRIs, benzodiazepines) within 14 days before study entry [except for fluoxetine within 30 days]. Concurrent use is prohibited during the study. Use of beta-adrenergic blocking agents ("beta blockers") within 14 days before study entry. Concurrent use is prohibited during the study. Use of any over-the-counter, prescription, or herbal product for treating symptoms of anxiety or social anxiety within 14 days before study entry. Concurrent use is prohibited during the study. Inability to complete the assessments or test sessions. Clinical conditions assessed by the interviewer that necessitate more imminent clinical care. These criteria are in place so participants with these other, more several symptoms can be referred for appropriate services. Prior participation in a clinical trial involving cannabinoids. Non-correctable vision or hearing problems, as some tests require intact sensory functioning. No telephone or easy access to telephone. Severe depression symptoms (PHQ-9 >= 20)
Sites / Locations
- University of California, San DeigoRecruiting
Arms of the Study
Arm 1
Arm 2
Arm 3
Active Comparator
Active Comparator
Placebo Comparator
Cannabidiol 900 mg/d
Cannabidiol 300 mg/d
Placebo
Participants will receive CBD (900 mg/d). Evenly split doses of 450 mg will be taken at morning and evening meals for 3 days, and a 450 mg dose will be taken in the morning of day 4 (before the post-test).
Participants will receive CBD (300 mg/d). Evenly split doses of 150 mg will be taken at morning and evening meals for 3 days, and a 150 mg dose will be taken in the morning of day 4 (before the post-test).
Participants will receive a CBD matching placebo. Evenly split doses will be taken at morning and evening meals for 3 days, and a dose will be taken in the morning of day 4 (before the post-test).