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Cannabinoid
Cannabidiol for Social Anxiety Disorder
Phase 2
Recruiting
Led By Murray B Stein, MD, MPH
Research Sponsored by University of California, San Diego
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up day 4
Awards & highlights
Study Summary
This trial aims to explore how CBD affects anxiety responses, by testing two doses on 60 people with SAD over 4 days. Outcomes include changes in brain molecule anandamide and anxiety.
Who is the study for?
This trial is for adults aged 18-70 with a primary diagnosis of social anxiety disorder, confirmed by specific clinical interviews and questionnaires. Participants must not have bipolar or psychotic disorders, major neurological issues, severe medical conditions, or be on medications that interact with CBD. They should not be undergoing certain psychosocial treatments or taking psychotropic drugs recently.Check my eligibility
What is being tested?
The study tests how cannabidiol (CBD), derived from Cannabis sativa, affects stress responses in those with social anxiety disorder over a short period. Subjects will receive either one of two CBD doses or a placebo twice daily for three days and once on the fourth day to see its impact on anandamide levels and reaction to stress tasks.See study design
What are the potential side effects?
While the trial description does not specify side effects of CBD, common ones may include tiredness, changes in appetite/weight, gastrointestinal issues like diarrhea, and potential interactions with other medications.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ day 4
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~day 4
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Anandamide
Change in state anxiety (SUDs) during stress task anticipation phase
Change in state anxiety (SUDs) during stress task performance phase
Secondary outcome measures
Change in negative self-statements during the stress task
Change in state anxiety (STAI) during stress task anticipation phase
Change in state anxiety (STAI) following the stress task
Other outcome measures
Change in 2-arachidonoylglycerol (2-AG) collected pre-stress task
Change in Emotion Recognition
Change in Emotional Attention Bias
+12 moreTrial Design
3Treatment groups
Active Control
Placebo Group
Group I: Cannabidiol 900 mg/dActive Control1 Intervention
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).
Group II: Cannabidiol 300 mg/dActive Control1 Intervention
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).
Group III: PlaceboPlacebo Group2 Interventions
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).
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Who is running the clinical trial?
University of California, San DiegoLead Sponsor
1,120 Previous Clinical Trials
1,521,347 Total Patients Enrolled
Murray B Stein, MD, MPHPrincipal InvestigatorUniversity of California, San Diego
8 Previous Clinical Trials
3,516 Total Patients Enrolled
Charles Taylor, PhDPrincipal InvestigatorUniversity of California, San Diego
1 Previous Clinical Trials
108 Total Patients Enrolled
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Eligibility Criteria:
This trial includes the following eligibility criteria:- I haven't taken beta blockers in the last 14 days and won't during the study.I have been diagnosed with bipolar or psychotic disorders.My doctor has found abnormal results in my blood, liver, kidney tests, or EKG.I have not used any cannabis products in the last week.I haven't used any anxiety medication or supplements in the last 14 days.I haven't taken any psychiatric drugs in the last 14 days, except fluoxetine which I haven't taken in the last 30 days.I cannot complete the required assessments or tests.I am currently receiving therapy for anxiety or mood disorders.I am taking medication that interacts with CBD.I do not have a major neurological disorder or severe medical conditions that could worsen by joining this study.I am experiencing severe depression.I have been diagnosed with social anxiety disorder.I have a high level of social anxiety, especially about public speaking.I am between 18 and 70 years old.
Research Study Groups:
This trial has the following groups:- Group 1: Cannabidiol 900 mg/d
- Group 2: Cannabidiol 300 mg/d
- Group 3: Placebo
Awards:
This trial has 0 awards, including:Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Are the elderly being considered for this experiment?
"Eligibility for this clinical trial requires patients to be under 70 years old and above the age of consent."
Answered by AI
Will I satisfy the requirements for participation in this trial?
"For entry into this clinical study, individuals must have been diagnosed with social anxiety disorder and be between 18 and 70 years old. The enrollment goal is to find 60 participants in total."
Answered by AI
Is 900 milligrams of Cannabidiol an accepted daily dosage according to the Food and Drug Administration?
"Cannabidiol 900 mg/d received a score of 2 due to the available data supporting its safety, though efficacy has yet to be conclusively demonstrated in any studies."
Answered by AI
How many people are taking part in this medical experiment?
"Affirmative. The information available on clinicaltrials.gov indicates that recruitment for this trial is ongoing, having first been posted on April 20th 2023 and most recently updated on the 10th of the same month. Aspiring participants must be one of 60 to join from a single site."
Answered by AI
Is enrollment open for this clinical study?
"Indeed, the information hosted on clinicaltrials.gov stipulates that this medical experiment has begun recruiting participants since its initial posting on April 20th 2021 and was last amended ten days after. The study is looking for 60 volunteers from one healthcare facility."
Answered by AI
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