Low dose RLS103 for Anxiety Disorders

Phase-Based Progress Estimates
1
Effectiveness
1
Safety
Anxiety Disorders+3 More
Low dose RLS103 - Drug
Eligibility
18+
All Sexes
What conditions do you have?
Select

Study Summary

This trial is testing a new drug to see if it can help people with social anxiety disorder during a public speaking challenge.

Eligible Conditions
  • Anxiety Disorders
  • Phobia, Social

Treatment Effectiveness

Effectiveness Progress

1 of 3

Study Objectives

1 Primary · 2 Secondary · Reporting Duration: 10 minutes, assessed at Visit 2 and Visit 3

Week 1
Change in CGI
Change in subject-reported anxiety
Week 1
Incidence and severity of adverse events
10 minutes, assessed at Visit 2 and Visit 3
Changes in blood pressure in subjects with SAD
Changes in pulse rate in subjects with SAD
Changes in respiratory rate in subjects with SAD

Trial Safety

Safety Progress

1 of 3

Trial Design

3 Treatment Groups

Low dose RLS103
1 of 3
High dose RLS103
1 of 3
placebo
1 of 3

Experimental Treatment

30 Total Participants · 3 Treatment Groups

Primary Treatment: Low dose RLS103 · Has Placebo Group · Phase 1

Low dose RLS103
Drug
Experimental Group · 1 Intervention: Low dose RLS103 · Intervention Types: Drug
High dose RLS103
Drug
Experimental Group · 1 Intervention: High dose RLS103 · Intervention Types: Drug
placebo
Drug
Experimental Group · 1 Intervention: placebo inhaled dry powder · Intervention Types: Drug

Trial Logistics

Trial Timeline

Screening: ~3 weeks
Treatment: Varies
Reporting: 10 minutes, assessed at visit 2 and visit 3

Who is running the clinical trial?

Receptor Life SciencesLead Sponsor

Eligibility Criteria

Age 18+ · All Participants · 10 Total Inclusion Criteria

Mark “Yes” if the following statements are true for you:
You must sign an informed consent form (ICF) indicating that you understand the purpose of the study and the procedures required for the study and are willing to participate in the study and attend all visits and requirements.
You are a non-smoker with no cigarettes, cigars, e-cigarettes, or nicotine-containing products used in the 1 month prior to Screening as confirmed by negative serum cotinine results (<10 ng/mL) at Screening.
You are a male or female aged 18 through 65 years.
You have a clinician-rated LSAS total score ≥75 at Screening (Visit 1).
You have a clinician-rated score of 17 or less on the Hamilton Depression Scale 17-item total score.
You have no known medical contraindication to CBD.
You have negative viral serology test results (HIV-1/HIV-2, hepatitis B and C virus).

About The Reviewer

Michael Gill preview

Michael Gill - B. Sc.

First Published: October 20th, 2021

Last Reviewed: November 23rd, 2022

Michael Gill holds a Bachelors of Science in Integrated Science and Mathematics from McMaster University. During his degree he devoted considerable time modeling the pharmacodynamics of promising drug candidates. Since then, he has leveraged this knowledge of the investigational new drug ecosystem to help his father navigate clinical trials for multiple myeloma, an experience which prompted him to co-found Power Life Sciences: a company that helps patients access randomized controlled trials.