Social Anxiety DisorderPhase 1NCT05429788
Safety, Tolerability, and Efficacy of RLS103 in Subjects With Acute Anxiety Within Social Anxiety Disorder (SAD)
A Phase 1 study testing Low dose RLS103 and High dose RLS103 in people with Social Anxiety Disorder, run by Receptor Life Sciences at 3 sites in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Social Anxiety Disorder
- What is being tested?
- Low dose RLS103 and High dose RLS103
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 0 participants
- Where
- 3 sitesUnited States
- Study dates
- 18 May 2022to 8 Nov 2022
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
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- 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.
- Must demonstrate the ability to use the inhaler correctly through a training tool and must be able to tolerate inhalation of a placebo powder.
- Must have the ability and willingness to attend the necessary clinic visits.
Who cannot join
- 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
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- 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).
- Use of any over-the-counter product, prescription product, or herbal preparation for treatment of the symptoms of anxiety or social anxiety within 30 days before study entry; concomitant use is prohibited during the study.
- Pregnant or lactating at Screening or planning to become pregnant (self or partner) at any time during the study, including the follow-up period.
- Currently using marijuana, marijuana cigarettes, cannabis-related products, or CBD; or have used any of these products within 3 weeks prior to Screening (at the discretion of the Investigator in consultation with the Sponsor, to be confirmed by a urine drug test at Screening).
- Any history of pulmonary disease, including bronchospastic respiratory disease (bronchial asthma), or chronic obstructive pulmonary disease.
- Clinically significant abnormal values for ECG, chest X-ray, or spirometry, or hematology, serum chemistry, or urinalysis at Screening as deemed appropriate by the Investigator, including:
- Alanine aminotransferase (ALT) and/or aspartate aminotransferase (AST) >1.5 × the ULN
- Total bilirubin >1.5 × ULN (isolated bilirubin >1.5 ×ULN is acceptable if total bilirubin and direct bilirubin <35%)
- Lymphoma, leukemia, or any malignancy within the past 5 years except for basal cell or squamous epithelial carcinomas of the skin that have been resected with no evidence of metastatic disease for 3 years.
- Received an investigational medicinal product within 30 days or 5 half-lives prior to Baseline, whichever is longer.
- Donated blood or blood products or had substantial loss of blood (more than 500 mL) within 3 months before the first administration of study drug or intention to donate blood or blood products during the study.
- Fever (body temperature >38°C) or symptomatic viral or bacterial infection within 2 weeks prior to Screening, including confirmed active COVID-19.
- Had major surgery (general anesthetic) in the last 3 months or minor surgery (local anesthetic) in the last 1 month prior to Screening or have any pre-planned surgery or procedures that would interfere with the conduct of the study.
- Is an employee of the Investigator or study site, with direct involvement in the proposed study or other studies under the direction of that Investigator or study site, as well as family members of the employees or the Investigator.
Trial locations and contacts
3 sites in 1 country.
United States3 sites
Receptor 102
Los Angeles, California, 90024
Receptor 105
Oceanside, California, 92056
Receptor 103
Torrance, California, 90502
About this study
Official title: 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)
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.
- Conditions
- Social Anxiety Disorder
- Being tested
- Low dose RLS103, High dose RLS103, placebo inhaled dry powder
- Medical subject headings
- Phobia, Social
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Low dose RLS103Drug
3 mg CBD inhaled powder administered before public speaking challenge
High dose RLS103Drug
6 mg CBD inhaled powder administered before public speaking challenge
placebo inhaled dry powderDrug
placebo inhaled powder administered before public speaking challenge
| Study group | Role | What they receive |
|---|---|---|
| Low dose RLS103 | Experimental | 3 mg CBD inhaled dry powder Receives: Drug: Low dose RLS103 |
| High dose RLS103 | Experimental | 6 mg CBD inhaled dry powder Receives: Drug: High dose RLS103 |
| placebo | Experimental | placebo inhaled dry powder Receives: Drug: placebo inhaled dry powder |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence and severity of adverse events
Safety and tolerability of RLS103 will be assessed by evaluating the incidence and severity of treatment emergent serious adverse events (TESAEs), treatment emergent adverse events (TEAEs), and adverse events (AEs) leading to discontinuation from the study.
Measured: 1 week (visit 3 to follow up visit)
Secondary outcomes (2)
Change in subject-reported anxiety
To evaluate and compare the average Subjective Units of Distress Scale (SUDS) between RLS103- and placebo-treated patients reported during the 5-minute performance phases of the Visit 2 and Visit 3 public speaking challenge
Measured: 1 week (Visit 2 to Visit 3)
Change in CGI
Investigator's impression of improvement of anxiety via the Clinical Global Impressions Scale (CGI) from Visit 2 to Visit 3
Measured: 1 week (Visit 2 to Visit 3)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Jun 2022
- Study start18 May 2022
- Primary completion8 Nov 2022
- Study completion8 Nov 2022
Why it stopped: Lack of enrollment
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Social Anxiety DisorderStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Receptor Life Sciences
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05429788
- Sponsor's protocol ID
- RC2022-01
- Status last verified
- Mar 2024
- First submitted
- 14 Jun 2022
- Last updated
- 2 Apr 2024
- Results posted
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Apr 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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)
- ClinicalTrials.gov ID
- NCT05429788
- Acronym / sponsor ID
- RC2022-01
- Conditions
- Social Anxiety Disorder
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Lack of enrollment
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Receptor Life SciencesIndustry (pharma, biotech, devices)
- Study start
- 18 May 2022 (actual)
- Primary completion
- 8 Nov 2022 (actual)
- Study completion
- 8 Nov 2022 (actual)
- First posted
- 23 Jun 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Low dose RLS103 | Experimental | Drug: Low dose RLS1033 mg CBD inhaled dry powder |
| High dose RLS103 | Experimental | Drug: High dose RLS1036 mg CBD inhaled dry powder |
| placebo | Experimental | Drug: placebo inhaled dry powderplacebo inhaled dry powder |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (12 listed)
- 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).
Key exclusion criteria (23 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Low dose RLS1033 mg CBD inhaled powder administered before public speaking challenge | Drug | Low dose RLS103 |
| High dose RLS1036 mg CBD inhaled powder administered before public speaking challenge | Drug | High dose RLS103 |
| placebo inhaled dry powderplacebo inhaled powder administered before public speaking challenge | Drug | placebo |
Primary outcome
Incidence and severity of adverse events
Time frame: 1 week (visit 3 to follow up visit)
Safety and tolerability of RLS103 will be assessed by evaluating the incidence and severity of treatment emergent serious adverse events (TESAEs), treatment emergent adverse events (TEAEs), and adverse events (AEs) leading to discontinuation from the study.
2 secondary outcomes
Change in subject-reported anxiety
Time frame: 1 week (Visit 2 to Visit 3)
Change in CGI
Time frame: 1 week (Visit 2 to Visit 3)
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Apr 2024.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Low dose RLS103 and High dose RLS103 in people with Social Anxiety Disorder, run by Receptor Life Sciences at 3 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 12 inclusion and 23 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: withdrawn, as of the sponsor's last update on 2 Apr 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence and severity of adverse events (time frame: 1 week (visit 3 to follow up visit)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Apr 2024.