Inhaled CBD for Social Anxiety Disorder
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial tests an inhaled CBD powder called RLS103 to determine its safety and effectiveness in helping people with social anxiety disorder (SAD) manage anxiety triggered by public speaking. Participants will receive either a low dose, a high dose, or a placebo for comparison. This trial suits individuals diagnosed with SAD who often feel anxious in social situations, particularly during public speaking. Participants will engage for about 4 to 6 weeks, including a screening phase, a public speaking test, and follow-up visits. As a Phase 1 trial, this research aims to understand how the treatment works in people, offering participants the chance to be among the first to receive this new treatment.
Will I have to stop taking my current medications?
Yes, you will need to stop taking any psychotropic or beta blocker medications at least 14 days before joining the study. Additionally, you cannot use any over-the-counter products, prescription products, or herbal preparations for anxiety or social anxiety within 30 days before the study and during the study.
Is there any evidence suggesting that RLS103 is likely to be safe for humans?
Research shows that RLS103, a dry powder form of cannabidiol (CBD) for inhalation, is generally safe and well-tolerated. Earlier studies found that people who took both oral and inhaled CBD experienced few side effects after just one dose. The main goal was to observe the body's response to the treatment.
Participants who tried the inhaled dry powder CBD found it safe and fast-acting. Results indicated that this form of CBD did not cause major negative reactions, demonstrating good tolerance.
Although this trial is in its early stages, current evidence suggests that RLS103 might be safe to use. However, early trials are still gathering more detailed safety information. Researchers will closely monitor participants to ensure their safety.12345Why do researchers think this study treatment might be promising for social anxiety disorder?
Unlike the standard treatments for Social Anxiety Disorder (SAD), which typically include oral medications like SSRIs and SNRIs, RLS103 offers a new approach with its inhaled dry powder form of CBD. This unique delivery method allows for rapid absorption into the bloodstream, potentially providing quicker relief from acute anxiety symptoms in social settings. Researchers are excited about RLS103 because it taps into the calming effects of CBD, a compound that's gaining attention for its anxiety-reducing properties, without the lengthy onset time associated with traditional oral medications. Additionally, the trial is exploring both low and high doses, which could offer flexible treatment options based on individual needs and responses.
What evidence suggests that RLS103 could be an effective treatment for social anxiety disorder?
Research has shown that inhaled dry powder cannabidiol (CBD), such as RLS103, works faster and absorbs better than traditional oral CBD. Studies have found that this method maintains effective drug levels in the lungs, potentially managing symptoms quickly. Inhaled CBD is designed to be stable and efficiently reach the lungs. Although limited data from human studies exist, these early findings suggest that RLS103 could be promising for reducing anxiety in social situations, especially during activities like public speaking.34678
Are You a Good Fit for This Trial?
Inclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants undergo a public speaking test after screening tests are performed and eligibility is confirmed
Follow-up
Participants are monitored for safety and effectiveness after treatment, involving a repeat of the safety and psychiatric assessments conducted during screening
What Are the Treatments Tested in This Trial?
Interventions
- RLS103
How Is the Trial Designed?
3
Treatment groups
Experimental Treatment
placebo inhaled dry powder
3 mg CBD inhaled dry powder
6 mg CBD inhaled dry powder
Find a Clinic Near You
Who Is Running the Clinical Trial?
Receptor Life Sciences
Lead Sponsor
Published Research Related to This Trial
Citations
Preparation and in vitro characterization of inhalable ...
Inhaled CBD dry powders have been found effective in maintaining effective drug concentrations in the lungs. For instance, a phase I clinical study demonstrated ...
Influence of Different Amino Acids on the Aerosolization ...
Results and conclusion: The prepared CBD dry powders exhibited a size range of 1–5 µm. Amino-acid-free CBD powder showed an irregular and flaky ...
Improved Bioavailability with Dry Powder Cannabidiol ...
These data indicate that DPI CBD provided more rapid onset and increased bioavailability than oral CBD and support further investigations on the use of DPI CBD ...
Preparation and in vitro characterization of inhalable ...
This study developed a CBD dry powder using spray drying with Inulin and L-leucine, showing improved aerosolization, stability, and anti- ...
Receptor Life Sciences Announces FDA Acceptance of ...
RLS103, a dry powder inhaled cannabidiol (CBD), is a first-in-class drug/device combination product for the acute treatment of social anxiety ...
Improved Bioavailability with Dry Powder Cannabidiol ...
Both Epidiolex and DPI CBD were generally safe and well-tolerated. These data indicate that DPI CBD provided more rapid onset and increased ...
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clinicaltrials.gov
clinicaltrials.gov/study/NCT05678881?term=AREA%5BConditionSearch%5D(%22Epilepsy,%20Reflex%22)&rank=2Safety, Tolerability, and Efficacy of RLS103 in a Clinical ...
Approximately 5 subjects with a known stable photoparoxysmal response (PPR) on EEG, will be administered high dose RLS103 and placebo in a blinded, ...
8.
offerco.jp
offerco.jp/wp-content/uploads/2023/07/SDS-Sheet-Octave-Labs-Cannabidiol-CAS-13956-29-1-031022.pdfSafety Data Sheet
Advice for non-emergency personnel: Avoid inhalation of dusts. Avoid substance contact. Ensure adequate ventilation. Evacuate the danger area, observe emergency ...
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