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Cannabinoid

Cannabidiol for Social Anxiety Disorder (CAN-SAD Trial)

Phase 4
Waitlist Available
Led By John Gabrieli, PhD
Research Sponsored by Massachusetts Institute of Technology
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be between 18 and 65 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up -180 minutes, -15 minutes, -5 minutes, +10 minutes, +20 minutes, +30 minutes
Awards & highlights
Pivotal Trial
Drug Has Already Been Approved

Summary

This trial tests if taking one dose of a cannabidiol medicine can reduce symptoms of social anxiety disorder.

Who is the study for?
Adults aged 18-55 with social anxiety disorder, not using drugs or certain medications like beta-blockers and benzodiazepines recently. Participants must be fluent in English, right-hand dominant, have stable medication use for the last month, and women must test negative for pregnancy.
What is being tested?
The trial is testing if a single dose of Epidiolex (cannabidiol) can lower anxiety levels in people with social anxiety disorder. It measures psychological responses, physiological signs of stress, and brain activity changes.
What are the potential side effects?
Cannabidiol may cause tiredness, diarrhea, changes in appetite/weight. Rarely it could lead to liver issues or affect mood and behavior. Side effects vary from person to person.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~-180 minutes, -15 minutes, -5 minutes, +10 minutes, +20 minutes, +30 minutes
This trial's timeline: 3 weeks for screening, Varies for treatment, and -180 minutes, -15 minutes, -5 minutes, +10 minutes, +20 minutes, +30 minutes for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Change in Acute Subjective Anxiety
Secondary study objectives
Differences in Salivary Alpha Amylase
Other study objectives
Differences in fMRI BOLD Response

Awards & Highlights

Pivotal Trial
The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.
Drug Has Already Been Approved
The FDA has already approved this drug, and is just seeking more data.

Trial Design

2Treatment groups
Active Control
Placebo Group
Group I: CannabidiolActive Control1 Intervention
300mg Cannabidiol (3mL Epidiolex), oral, single-dose
Group II: PlaceboPlacebo Group1 Intervention
Placebo (3mL sesame seed oil), oral, single-dose

Find a Location

Who is running the clinical trial?

Massachusetts Institute of TechnologyLead Sponsor
101 Previous Clinical Trials
12,821,975 Total Patients Enrolled
Massachusetts General HospitalOTHER
3,026 Previous Clinical Trials
13,413,749 Total Patients Enrolled
John Gabrieli, PhDPrincipal InvestigatorMassachusetts Institute of Technology
4 Previous Clinical Trials
382 Total Patients Enrolled
John D.E. Gabrieli, PhDPrincipal InvestigatorMassachusetts Institute of Technology
1 Previous Clinical Trials
50 Total Patients Enrolled

Media Library

Cannabidiol (Cannabinoid) Clinical Trial Eligibility Overview. Trial Name: NCT05649059 — Phase 4
Social Anxiety Disorder Research Study Groups: Placebo, Cannabidiol
Social Anxiety Disorder Clinical Trial 2023: Cannabidiol Highlights & Side Effects. Trial Name: NCT05649059 — Phase 4
Cannabidiol (Cannabinoid) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05649059 — Phase 4
~25 spots leftby May 2025
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