Social Anxiety DisorderPhase 2NCT05600114
Cannabidiol (CBD) for the Treatment of Social Anxiety Disorder
A Phase 2 study testing Cannabidiol oral solution in people with Social Anxiety Disorder, run by EmpowerPharm Inc. at 17 sites in United States.
Trial summary
A phase 2, multicenter, double-blind, parallel group, placebo-controlled, randomized clinical study, designed to compare the efficacy, safety, and tolerability of 2 dose levels of CBD and a matching placebo for the treatment of subjects with Social Anxiety Disorder (SAD). Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Social Anxiety Disorder
- What is being tested?
- Cannabidiol oral solution
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 239 participants
- Where
- 17 sitesUnited States
- Study dates
- 27 Oct 2022to 13 Dec 2023
- Phase
- Phase 2
- 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 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Clinically predominant diagnosis of Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition (DSM-5) SAD
- LSAS score of 70 or higher
- Females of childbearing potential must test negative for pregnancy and agree to use a reliable birth control method. Male subjects must also agree to use highly effective methods of contraception.
- Read, understand, and sign the informed consent form.
- No significant physical health abnormalities based on physical exam, ECG and laboratory tests.
Who cannot join
- Other current psychiatric disorder as the clinically predominant diagnosis.
- Lifetime diagnosis of schizophrenia or any other psychosis, MDD with psychotic features, intellectual disability, autism spectrum disorders, bipolar disorder type 1, and cannabis use disorder
- Previous 6 months diagnosis of Post-traumatic stress disorder, obsessive compulsive disorder, moderate to severe alcohol use disorder, and substance abuse disorder (except tobacco use disorder or mild alcohol use disorder)
- Severe MDD
- Use of oral psychoactive medications or beta adrenergic antagonists in the past 4 weeks, or depot neuroleptics within 12 weeks
- Electroconvulsive therapy within 6 months, psychotherapy or transcranial magnetic stimulation within 3 months
Show all 13Show fewer
- Clinically significant abnormality or clinically significant unstable medical condition
- Impaired liver function
- Significant risk of suicide or homicide
- Pregnancy/lactation
- Sensitivity to CBD or excipients
- Current cannabis use; past frequent cannabis use
- Illegal drug use
Trial locations and contacts
17 sites in 1 country.
17 sites in 1 country
United States17 sites
EPI-CBD-001 Site
Bellevue, Washington, 98007
EPI-CBD-001 Site
Cedarhurst, New York, 11516
EPI-CBD-001 Site
Chicago, Illinois, 60640
EPI-CBD-001 Site
Encino, California, 91316
EPI-CBD-001 Site
Jacksonville, Florida, 32256
EPI-CBD-001 Site
Lauderhill, Florida, 33319
EPI-CBD-001 Site
Lemon Grove, California, 91945
EPI-CBD-001 Site
Los Alamitos, California, 90720
EPI-CBD-001 Site
Maitland, Florida, 32751
EPI-CBD-001-Site
New York, New York, 10036
EPI-CBD-001-Site
Oceanside, California, 92056
EPI-CBD-001 Site
Oklahoma City, Oklahoma, 73106
EPI-CBD-001 Site
Orlando, Florida, 32801
EPI-CBD-001 Site
Portland, Oregon, 97210
EPI-CBD-001-Site
Rochester, New York, 10036
EPI-CBD-001 site
San Jose, California, 95124
EPI-CBD-001 site
Wichita Falls, Texas, 76309
About this study
Official title: A Randomized, Double-Blind, Parallel Group, Placebo-Controlled Study, Evaluating the Efficacy, Safety, and Tolerability of Cannabidiol Oral Solution in Subjects With Social Anxiety Disorder
A phase 2, multicenter, double-blind, parallel group, placebo-controlled, randomized clinical study, designed to compare the efficacy, safety, and tolerability of 2 dose levels of CBD and a matching placebo for the treatment of subjects with Social Anxiety Disorder (SAD).
- Conditions
- Social Anxiety Disorder
- Being tested
- Cannabidiol oral solution, Placebo
- Medical subject headings
- Phobia, Social
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cannabidiol oral solutionDrug
CBD 150 mg BID
Cannabidiol oral solutionDrug
CBD 300 mg BID
PlaceboDrug
Placebo BID
| Study group | Role | What they receive |
|---|---|---|
| Cannabidiol (CBD) Oral Solution 300 mg/day | Experimental | Not described Receives: Drug: Cannabidiol oral solution |
| Cannabidiol (CBD) Oral Solution 600 mg/day | Experimental | Not described Receives: Drug: Cannabidiol oral solution |
| Placebo Oral Solution | Placebo comparator | Not described Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Mean change from baseline to endpoint in the Liebowitz Social Anxiety Scale (LSAS)
Measured: 10 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Oct 2022
- Study start27 Oct 2022
- Primary completion13 Dec 2023
- Study completion13 Dec 2023
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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 239 participants (actual)
Sponsor and investigators
- Lead sponsor
- EmpowerPharm Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05600114
- Sponsor's protocol ID
- EPI-CBD-001
- Status last verified
- Nov 2024
- First submitted
- 26 Oct 2022
- Last updated
- 21 Nov 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Nov 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Double-Blind, Parallel Group, Placebo-Controlled Study, Evaluating the Efficacy, Safety, and Tolerability of Cannabidiol Oral Solution in Subjects With Social Anxiety Disorder
- ClinicalTrials.gov ID
- NCT05600114
- Acronym / sponsor ID
- EPI-CBD-001
- Conditions
- Social Anxiety Disorder
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 239 participants (actual)
- Lead sponsor
- EmpowerPharm Inc.Industry (pharma, biotech, devices)
- Study start
- 27 Oct 2022 (actual)
- Primary completion
- 13 Dec 2023 (actual)
- Study completion
- 13 Dec 2023 (actual)
- First posted
- 31 Oct 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.
A phase 2, multicenter, double-blind, parallel group, placebo-controlled, randomized clinical study, designed to compare the efficacy, safety, and tolerability of 2 dose levels of CBD and a matching placebo for the treatment of subjects with Social Anxiety Disorder (SAD).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Cannabidiol (CBD) Oral Solution 300 mg/day | Experimental | Drug: Cannabidiol oral solution |
| Cannabidiol (CBD) Oral Solution 600 mg/day | Experimental | Drug: Cannabidiol oral solution |
| Placebo Oral Solution | Placebo comparator | Drug: Placebo |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Clinically predominant diagnosis of Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition (DSM-5) SAD
- LSAS score of 70 or higher
- Females of childbearing potential must test negative for pregnancy and agree to use a reliable birth control method. Male subjects must also agree to use highly effective methods of contraception.
- Read, understand, and sign the informed consent form.
- No significant physical health abnormalities based on physical exam, ECG and laboratory tests.
Key exclusion criteria (13 listed)
- Other current psychiatric disorder as the clinically predominant diagnosis.
- Lifetime diagnosis of schizophrenia or any other psychosis, MDD with psychotic features, intellectual disability, autism spectrum disorders, bipolar disorder type 1, and cannabis use disorder
- Previous 6 months diagnosis of Post-traumatic stress disorder, obsessive compulsive disorder, moderate to severe alcohol use disorder, and substance abuse disorder (except tobacco use disorder or mild alcohol use disorder)
- Severe MDD
- Use of oral psychoactive medications or beta adrenergic antagonists in the past 4 weeks, or depot neuroleptics within 12 weeks
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 |
|---|---|---|
| Cannabidiol oral solutionCBD 150 mg BID | Drug | Cannabidiol (CBD) Oral Solution 300 mg/day |
| Cannabidiol oral solutionCBD 300 mg BID | Drug | Cannabidiol (CBD) Oral Solution 600 mg/day |
| PlaceboPlacebo BID | Drug | Placebo Oral Solution |
Primary outcome
Mean change from baseline to endpoint in the Liebowitz Social Anxiety Scale (LSAS)
Time frame: 10 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Nov 2024.
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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.
17 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Cannabidiol oral solution in people with Social Anxiety Disorder, run by EmpowerPharm Inc. at 17 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 5 inclusion and 13 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: finished, as of the sponsor's last update on 21 Nov 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 17 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. Some participants in this study may receive a placebo. 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
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 is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Mean change from baseline to endpoint in the Liebowitz Social Anxiety Scale (LSAS) (time frame: 10 weeks). 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 21 Nov 2024.