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Safety, Tolerability, and Efficacy of RLS103 in Subjects With Acute Anxiety Within Social Anxiety Disorder (SAD) | Clinical Trials | Clareo Health

WITHDRAWNPHASE1

Safety, Tolerability, and Efficacy of RLS103 in Subjects With Acute Anxiety Within Social Anxiety Disorder (SAD)

A Phase 1b/2a Randomized, Double-Blind, Placebo Controlled, Parallel Study to Evaluate the Safety, Tolerability, and Efficacy of Two Doses of RLS103 (CBD Technosphere® Inhalation Powder) in Subjects With Acute Anxiety Within Social Anxiety Disorder (SAD)

NCT05429788•Receptor Life Sciences

View on ClinicalTrials.gov

Summary

This is a Phase 1b/2a clinical trial to evaluate the safety, tolerability, and efficacy of RLS103 (cannabidiol \[CBD\] inhaled dry powder) to relieve the anxiety induced by a public speaking challenge in adults with social anxiety disorder (SAD). Subject participation will last 4 - 6 weeks. Upon signing an informed consent, all subjects will enter a screening phase lasting up to 3 weeks and including history, physical examination, laboratory tests, ECG, spirometry, and psychological tests. Subjects will undergo a public speaking test after screening tests are performed and eligibility is confirmed. One week after the completion of the public speaking test, subjects will come back for a follow-up visit that will involve a repeat of the safety and psychiatric assessments conducted during screening.

Eligibility

Age

18 - 65 years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•Must sign an informed consent form (ICF) indicating that they 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.
•Male or female 18 through 65 years of age, inclusive.
•Current diagnosis of SAD as defined in the MINI.
•Clinician-rated LSAS total score ≥75 at Screening (Visit 1).
•Clinician-rated Hamilton Depression Score 17-items total score \<18 at Screening (Visit 1).
•Women of childbearing potential must commit to the consistent and correct use of an effective method of birth control throughout the study and must also have negative pregnancy test result at Screening (Visit 1), Baseline (Visit 2), and Visit 3. Effective methods of contraception include surgical sterilization of the subject, condoms with spermicide, diaphragm with spermicide, hormonal contraceptive agents (oral, transdermal, or injectable), or implantable contraceptive devices.
•Body mass index (BMI) between 18 and 32 kg/m2 (inclusive) with a body weight ≥50 kg.
•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.
•Negative viral serology test results (HIV-1/HIV-2, hepatitis B and C virus).
•Must have no medical contraindication to CBD, including known allergies or hypersensitivities to CBD or the excipients in RLS103.
+2 more criteria

Exclusion Criteria

•Any history of bipolar disorder (I or II), schizophrenia, schizoaffective disorder, psychosis, anorexia or bulimia, premenstrual dysphoric disorder, autism-spectrum disorder, or obsessive-compulsive disorder.
•Any other current Axis I disorder, other than SAD, which is the primary focus of treatment. Note that subjects with concurrent Generalized Anxiety Disorder are eligible for the study provided that Generalized Anxiety Disorder is not the primary diagnosis.
•Subject with alcohol or substance use disorder within the 1 year prior to study entry.
•In the opinion of the Investigator, has a significant risk for suicidal behavior during the course of their participation in the study, or
•At Screening (Visit 1): the subject scores "yes" on items 1 or 2 in the C-SSRS with reference to a 6-month period prior to Screening; or
•At Screening (Visit 1): the subject has had 1 or more suicidal attempts with reference to a 2-year period prior to Screening; or
•At Visit 2 or Visit 3: the subject scores "yes" on items 1 or 2 in the Suicidal Ideation section of the C-SSRS with reference to Screening; or
•The subject is considered to be an imminent danger to themself or others.
•Two or more documented failed treatment trials with a registered medication approved for SAD, in the last three years whereby an adequate treatment trial is defined as that described in the package insert for a particular drug during which the subject received an adequate medication dosage (defined as the treatment dose indicated in the package insert to obtain efficacy for that particular drug).
•Use of any psychotropic or beta blocker medications within 14 days before study entry (other than medication permitted for insomnia: eszopiclone, ramelteon, melatonin, zaleplon, zolpidem, or antihistamines).
+13 more criteria

Locations (3)

Receptor 102

Los Angeles, California, United States

Receptor 105

Oceanside, California, United States

Receptor 103

Torrance, California, United States

Key Dates

Start Date

May 18, 2022

Primary Completion Date

November 8, 2022

Completion Date

November 8, 2022

Last Updated

April 2, 2024

Conditions

Social Anxiety Disorder

Interventions

Low dose RLS103

DRUG

High dose RLS103

DRUG

placebo inhaled dry powder

DRUG

ACTsocially: The (Dis)Similarities of ACT for Changing Internalizing and Externalizing Symptomatology in Adolescence

NCT07456631

Social Anxiety Disorder (SAD)Oppositional Defiant Disorder

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RECRUITINGNA

Internet-Delivered Cognitive Behavioral Intervention for Youths With Anxiety Disorders

NCT06661460

ANXIETY DISORDERS (or Anxiety and Phobic Neuroses)Specific Phobia+5 more

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: April 2, 2024Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

View ClinicalTrials.gov Terms and Conditions

Safety, Tolerability, and Efficacy of RLS103 in Subjects With Acute Anxiety Within Social Anxiety Disorder (SAD)

Inclusion Criteria

Exclusion Criteria

ACTsocially: The (Dis)Similarities of ACT for Changing Internalizing and Externalizing Symptomatology in Adolescence

Internet-Delivered Cognitive Behavioral Intervention for Youths With Anxiety Disorders

Individual Factors of CBT Underlying Success

Comparing TBT to Disorder-Specific Psychotherapy in Veterans With Social Anxiety Disorder

Application of Virtual Reality Technology to Treatment of Social Anxiety

Intervention Social Anxiety: Combining Parent-child Treatment