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Cannabidiol as a Treatment for Social Anxiety Disorder (R61)

NCT05571592 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 60

Last updated 2026-01-07

No results posted yet for this study

Summary

The R61 will include two CBD dose levels vs placebo (PBO) and examine potential engagement with two primary targets in a 3-week randomized controlled trial design. Willing and eligible subjects will be randomized to one of three randomized double-blind treatments (n = 20 each group): 1) CBD 800 mg (400 mg twice daily), 2) CBD 400 mg (200 mg twice daily), or 3) PBO twice daily for three weeks.

Participation is estimated at approximately 1 month from end of screening to endpoint for the primary R61 study period. This includes screening, baseline, week 2 stress task, Week 3 2-day imaging paradigm, and clinical safety assessments at weeks 2 and 3.

Conditions

Interventions

DRUG

Cannabidiol

Oral Capsule Formulation of CBD dissolved in a self-emulsifying drug technology called nanodomains, encapsulated within 1-ml softgel capsules, with a CBD purity ≥98%. Imported from Ananda Scientific

DRUG

Placebo

Drug: Placebo Placebo softgel capsule formulation.

Sponsors & Collaborators

  • Ananda Scientific

    collaborator UNKNOWN

  • National Center for Complementary and Integrative Health (NCCIH)

    collaborator NIH

  • NYU Langone Health

    lead OTHER

Principal Investigators

  • Naomi Simon, MD · NYU Langone Health

  • Esther Blessing, MD · NYU Langone Health

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
45 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2023-01-26
Primary Completion
2025-11-26
Completion
2025-12-03
FDA Drug
Yes

Countries

  • United States

Study Locations

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Entities

Drugs
Diseases
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05571592 on ClinicalTrials.gov