Social Anxiety DisorderPhase 2NCT05571592
Cannabidiol as a Treatment for Social Anxiety Disorder (R61)
A Phase 2 study testing Cannabidiol in people with Social Anxiety Disorder, run by NYU Langone Health at 1 site in United States.
Trial summary
The R61 will include two CBD dose levels vs placebo (PBO) and examine potential engagement with two primary targets in a 3-week randomized controlled trial design. Willing and eligible subjects will be randomized to one of three randomized double-blind treatments (n = 20 each group): 1) CBD 800 mg (400 mg twice… Read more about this study
- Who is it for?
- Ages 18 to 45 years
- Conditions the study is for
- Social Anxiety Disorder
- What is being tested?
- Cannabidiol
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 60 participants
- Where
- 1 siteUnited States
- Study dates
- 26 Jan 2023to 3 Dec 2025
- 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 45 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Male or female outpatients aged 18 to 45 years of age
- A primary mental health complaint (designated by the patient as the most important source of current distress and confirmed on Structured Clinical Interview for DSM-5 diagnoses by a certified clinical evaluator) of Social Anxiety Disorder (SAD), as defined by DSM-5 criteria
- Overall social anxiety severity defined by a Liebowitz Social Anxiety Scale (LSAS) score of at least 60
- Willingness and ability to participate in the informed consent process and comply with the requirements of the study protocol. Includes compliance with the requirements and restrictions listed in ICF and in the protocol (including consent to abstain from using marijuana, any cannabis-related products, or any tobacco products during the study).
Who cannot join
- Known allergy or hypersensitivity to CBD or any of the excipients
- A lifetime history of bipolar disorder, schizophrenia, psychosis, or delusional disorders; obsessive-compulsive disorder or an eating disorder in the past 12 months; neurocognitive disorders, intellectual disabilities, communication disorders or other cognitive dysfunction that could interfere with capacity to engage in therapy or complete study procedures; major depressive disorder, substance or alcohol use disorder (other than nicotine) in the last 6 months.
- Positive urine toxicology for illicit drugs and/or cannabinoids, or self-reported use of CBD, THC or marijuana in the past 4 weeks prior to baseline
- Patients with significant suicidal ideation (assessed by CSSRS SI score greater than 2) or who have enacted suicidal behaviors within 6 months prior to intake will be excluded from study participation and referred for appropriate clinical intervention.
- Patients must be free of concurrent psychotropic medications including antipsychotics, anticonvulsants, benzodiazepines, and opioids, and medications that both have a narrow therapeutic index as determined by the study clinician, and are also substrates or moderate to strong inhibitors of CYP2C9, CYP2C19, CYP3A5, CYP3A7, UGT1A9, UGT2B7, CYP2C8, CYP1A2 or CYP2B6, or are strong inducers of CYP3A4 or CYP2C19, for at least 4 weeks prior to initiation of randomized treatment.
- Inability to understand study procedures or informed consent process, or significant personality dysfunction likely to interfere with study participation (assessed during the clinical interview) or inability to comply with study procedures (such as planned extended travel) assessed on clinical interview.
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- Serious current unstable medical illness, or a condition for which hospitalization may be likely within the next year as assessed by medical history and physical exam. If any questions about medical safety emerge with screening procedures, consent will be formally obtained to contact patient's PCP in order to determine whether any medical concerns making participation unsafe or not feasible (such as need for extended inpatient care or medications with concern for significant drug interactions and/or safe utilization of CBD) are present.
- Clinically significant abnormal physical examination, vital signs or 12 lead ECG at screening. Clinically significant abnormal values for hematology, clinical chemistry, or urinalysis at screening.
- Pregnant women (to be ruled out by urine ß-HCG) and women of childbearing potential who are not using medically accepted forms of contraception (such as IUD, oral contraceptives, barrier devices, condoms and foam, or implanted progesterone rods stabilized for at least 3 months). Men must also be using at least one medically accepted form of contraception.
- Any concurrent psychotherapy initiated within 3 months of baseline, or ongoing psychotherapy of any duration directed specifically toward treatment of SAD. Prohibited psychotherapy includes CBT, DBT, ACT, mindfulness-based approaches or psychodynamic therapy focusing on exploring specific, dynamic causes of the SAD symptomatology and providing management skills. General supportive therapy initiated greater than 3 months prior is acceptable.
- Has received an investigational drug or used an invasive investigational medical device within 1 month or within a period less than 10 times the drug's half-life, whichever is longer, before Day 1
- Patients with a history of head trauma causing loss of consciousness, seizure or ongoing cognitive impairment.
- Contraindications for MRI including metal implants, surgical clips, probability of metal fragments, or braces that are prohibited due to severe risk of injury.
- Left-handed
- A prior history of a diagnosis of moderate to severe hepatic dysfunction or current bilirubin >=1.5X ULN and/or ALT or AST as 2X ULN, and/or if clinically significant signs and symptoms that are together suggestive of significant hepatic injury (i.e., nausea, vomiting, right upper quadrant pain, anorexia, fatigue, jaundice, dark urine).
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Randomized Placebo-controlled Trial to Determine the Biological Signature of Cannabidiol as a Treatment for Social Anxiety Disorder (R61)
The R61 will include two CBD dose levels vs placebo (PBO) and examine potential engagement with two primary targets in a 3-week randomized controlled trial design. Willing and eligible subjects will be randomized to one of three randomized double-blind treatments (n = 20 each group): 1) CBD 800 mg (400 mg twice daily), 2) CBD 400 mg (200 mg twice daily), or 3) PBO twice daily for three weeks.
Participation is estimated at approximately 1 month from end of screening to endpoint for the primary R61 study period. This includes screening, baseline, week 2 stress task, Week 3 2-day imaging paradigm, and clinical safety assessments at weeks 2 and 3.
Read the detailed description
In the R61 trial, two doses of a Phase 3 trial suitable hemp-derived (legal) oral CBD formulation with enhanced bioavailability will be compared against placebo (PBO) in a 3-week double-blind randomized controlled trial. Participants will undergo a standardized stress task at week 2, and a standardized 2-day fear learning and extinction protocol at week 3, with functional MRI (fMRI) brain activation accompanying fear extinction recall and fearful faces tasks on the second day.
- Conditions
- Social Anxiety Disorder
- Being tested
- Cannabidiol, Placebo
- Keywords
- CBD, Cannabidiol
- Medical subject headings
- Phobia, Social
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CannabidiolDrug
Also called Nantheia (A1002N5S) Softgel Capsules
Oral Capsule Formulation of CBD dissolved in a self-emulsifying drug technology called nanodomains, encapsulated within 1-ml softgel capsules, with a CBD purity ≥98%. Imported from Ananda Scientific
PlaceboDrug
Drug: Placebo
Placebo softgel capsule formulation.
| Study group | Role | What they receive |
|---|---|---|
| Cannabidiol 400mg | Experimental | Participants assigned to 200mg twice-daily (400mg/day) dose for 3 weeks. Receives: Drug: Cannabidiol |
| Cannabidiol 800mg | Experimental | Participants assigned to 400mg twice-daily (800mg/day) dose for 3 weeks. Receives: Drug: Cannabidiol |
| Placebo | Placebo comparator | Participants assigned to twice-daily placebo dose for 3 weeks. Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Stress Task-Induced Anxiety as Measured by Visual Analogue Mood Scale (VAMS)
Participants rate their anxiety using the VAMS Anxiety Subscale, which assesses the intensity of anxiety over the previous few minutes. Higher scores indicate greater levels of anxiety. An increase in scores indicates anxiety increased during the observational period.
Measured: Baseline Phase, Speech Phase (Week 2)
Difference in Amygdala Beta-Weights in Activation in Response to Intensely Fearful Faces versus Neutral Faces as Measured by fMRI
Amygdala beta-weights in activation will be measured by functional MRI while viewing both neutral face expression images and intensely fearful face expression images during a Fearful Faces task.
Measured: Week 3
Change in Clinician-Rated Liebowitz Social Anxiety Scale (LSAS) Score
24-item questionnaire ranking Fear or Anxiety and Avoidance in a series of situations.
Fear or Anxiety ranked on 4-point Likert scale, where: 0 = None, 1 = Mild, 2 = Moderate, and 3 = Severe. Avoidance ranked on a 4-point Likert scale, where: 0 = Never (0%), 1= Occasionally (1 -33%), 2 = Often (33 - 67%), and 3 = Usually (67 - 100%).
Total scores range from 0 to 144; higher scores indicate greater severity of social anxiety: 0-54 = Mild social anxiety; 55-65 = Moderate social anxiety; 66-80 = Marked social anxiety; 81-95 = Severe social anxiety; Greater than 95 = Very severe social phobia (anxiety). An increase in scores indicates severity of social anxiety increased during the observational period.
Measured: Day 1, Week 3
Secondary outcomes (13)
Difference in Ventromedial Prefrontal Cortex (vmPFC) Activation Accompanying Fear Extinction Recall During fMRI
The vmPFC beta-weights in activation will be measured by functional MRI during fear extinction recall task.
Measured: Week 3
Mean Change in CBD Plasma Concentration from Pre-Treatment to Post-Treatment
Measured via patient blood draws taken immediately before dosing and 60 minutes post-dosing. Expressed in ng/mL.
Measured: Immediately Pre-Dose, 60 Minutes Post-Dose (Up to Week 3)
Change in Clinical Global Impression of Severity (CGI-S) Score
Clinician's rating of the severity of a participant's illness on 7-point scale from 1-7, where higher scores indicate greater severity of illness: 1 = Normal, not at all ill; 2= Borderline mentally ill; 3 = Mildly ill; 4 = Moderately ill; 5 = Markedly ill; 6 = Severely ill; and 7 = Among the most extremely ill patients. An increase in scores indicates severity of illness increased during the observational period.
Measured: Day 1, Week 3
Change in Clinical Global Impression of Improvement (CGI-I) Score
Clinician's assessment of how much the patient's illness has improved or worsened relative to a baseline state at the beginning of intervention on a 7-point scale, where lower scores indicate higher levels of improvement: 1 = Very much improved; 2 = Much improved; 3 = Minimally improved; 4 = No change; 5 = Minimally worse; 6 = Much worse; 7 = Very much worse. An increase in scores indicates illness improvement decreased during the observational period.
Measured: Day 1, Week 3
Change in Quick Inventory of Depressive Symptomatology, Self-Report (QIDS-SR) Score
16-item self-report questionnaire assessing depressive symptoms over the past week. Scores range from 0 to 27; higher scores indicate greater severity of depression: 0-5 = no depression; 6-10 = mild depression; 11-15 = moderate depression; 16-20 = severe depression; 21 and up = very severe depression. An increase in scores indicates severity of depression increased during the observational period.
Measured: Day 1, Week 3
Change in Perceived Stress Scale (PSS-10) Score
10-item self-report questionnaire assessing how different situations affect feelings and perceived stress. Items ranked on 5-point Likert scale: 0 = Never; 1 = Almost never, 2 = Sometimes, 3 = Fairly often, and 4 = Very often.
Scores range from 0-40; higher scores indicate higher levels of perceived stress: 0-13 = low stress; 14-26 = moderate stress; 27-40 = high perceived stress. An increase in scores indicates levels of perceived stress increased during the observational period.
Measured: Day 1, Week 3
Change in Anxiety Sensitivity Index-3 (ASI-3) Score
18-item self-report measure of fear of anxiety-related sensations. Items ranked on 5-point Likert scale: 0 = Very Little, 1 = A little, 2 = Some, 3 = Much, 4 = Very much.
Total scores range from 0-72; higher scores indicate higher levels of anxiety sensitivity: 0-17 = Almost No Anxiety Sensitivity; 18-35 = Low Anxiety Sensitivity; 36-53 = Moderate Anxiety Sensitivity; 54-72 = High Anxiety Sensitivity. An increase in scores indicates levels of anxiety sensitivity increased during the observational period.
Measured: Day 1, Week 3
Change in Insomnia Severity Index (ISI) Score
7-item self-report measure of insomnia severity, sleep dissatisfaction and interference related to sleep problems. Scores range from 0-28; higher scores indicate greater severity of insomnia: 0-7 = No clinically significant insomnia; 8-14 = Subthreshold insomnia; 15-21 = Clinical insomnia (moderate severity); 22-28 = Clinical insomnia (severe). An increase in scores indicates severity of insomnia increased during the observational period.
Measured: Day 1, Week 3
Change in Patient-Reported Outcomes Measurement Information System Ability to Participate in Social Roles and Activities (PROMIS-APS) Score
8-item self-assessment of perceived ability to perform one's usual social roles and activities. Items ranked on 5-point Likert scale: 1 = Always, 2 = Usually, 3 = Sometimes, 4 = Rarely, and 5 = Never.
The raw score is the sum of individual responses and ranges from 8 to 40; higher scores indicate greater ability to participate in social roles and activities. The raw score is translated to give a T-score for each participant. The T-score rescales the raw score into a standardized score with a mean of 50 and a standard deviation (SD) of 10. An increase in scores indicates ability to participate in social roles and activities increased during the observational period.
Measured: Day 1, Week 3
Change in Patient-Reported Outcomes Measurement Information System Satisfaction with Participation in Social Roles (PROMIS-SPS) Score
8-item self-assessment measuring satisfaction with performing one's usual social roles and activities over the previous 7 days. Items rated on 5-point Likert scale: 1 = Not at all, 2 = A little bit, 3 = Somewhat, 4 = Quite a bit, and 5 = Very much.
The raw score is the sum of individual responses and ranges from 8 to 40; higher scores indicate greater satisfaction with participation in social roles. The raw score is translated to give a T-score for each participant. The T-score rescales the raw score into a standardized score with a mean of 50 and a standard deviation (SD) of 10. An increase in scores indicates satisfaction with participation in social roles increased during the observational period.
Measured: Day 1, Week 3
Change in Patient-Reported Outcomes Measurement Information System (PROMIS) Anxiety Score
8-item self-assessment measuring fear, anxiety, and arousal in the past 7 days. Items rated on 5-point Likert scale: 1 = Never, 2 = Rarely, 3 = Sometimes, 4 = Often, and 5 = Always.
The raw score is the sum of individual responses and ranges from 8 to 40; higher scores indicate greater levels of anxiety. The raw score is translated to give a T-score for each participant. The T-score rescales the raw score into a standardized score with a mean of 50 and a standard deviation (SD) of 10. An increase in scores indicates levels of anxiety increased during the observational period.
Measured: Day 1, Week 3
Change in Self-Statements during Public Speaking Scale: Negative Thoughts (SSPS-N) Score
10-item self-assessment of fearful negative thoughts experienced during public speaking. Agreement with each item is scored on a 6-point Likert scale ranging from 0 (No agreement at all) to 5 (Extreme agreement). The total score is the sum of responses and ranges from 0 to 50; higher total scores indicate higher levels of agreement with negative self-statements. An increase in scores indicates agreement with negative self-statements increased during the observational period.
Measured: Day 1, Week 3
Number of Participants who Adhere to Treatment
Adherence defined as completion of at least 80% of dosing. Measured via the smartphone-assisted medication adherence platform called Emocha, which the participant uses to take a video of drug administration at each dose.
Measured: Up to Week 3
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Oct 2022
- Study start26 Jan 2023
- Primary completion26 Nov 2025
- Study completion3 Dec 2025
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.
- More trials run by NYU Langone HealthThe sponsor's other registered studies.
- 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
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- NYU Langone Health
- Sponsor type
- University, hospital or other
- Collaborators
- Ananda Scientific, National Center for Complementary and Integrative Health (NCCIH)
- Responsible party
- Sponsor
- Investigators
- Naomi Simon, MD, Principal investigator, NYU Langone HealthEsther Blessing, MD, Principal investigator, NYU Langone Health
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05571592
- Sponsor's protocol ID
- 22-00568-R61
- Status last verified
- Jan 2026
- First submitted
- 5 Oct 2022
- Last updated
- 7 Jan 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Yes: The primary cleaned de-identified dataset will be made available within twelve months of database lock or following publication of primary manuscript, whichever occurs first.
Study at a glance
From the registry record, last updated by the sponsor on 7 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomized Placebo-controlled Trial to Determine the Biological Signature of Cannabidiol as a Treatment for Social Anxiety Disorder (R61)
- ClinicalTrials.gov ID
- NCT05571592
- Acronym / sponsor ID
- 22-00568-R61
- Conditions
- Social Anxiety Disorder
- Keywords
- CBD, Cannabidiol
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- NYU Langone HealthUniversity, hospital or other
- Collaborators
- Ananda Scientific, National Center for Complementary and Integrative Health (NCCIH)
- Study start
- 26 Jan 2023 (actual)
- Primary completion
- 26 Nov 2025 (actual)
- Study completion
- 3 Dec 2025 (actual)
- First posted
- 7 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.
The R61 will include two CBD dose levels vs placebo (PBO) and examine potential engagement with two primary targets in a 3-week randomized controlled trial design. Willing and eligible subjects will be randomized to one of three randomized double-blind treatments (n = 20 each group): 1) CBD 800 mg (400 mg twice daily), 2) CBD 400 mg (200 mg twice daily), or 3) PBO twice daily for three weeks.
Participation is estimated at approximately 1 month from end of screening to endpoint for the primary R61 study period. This includes screening, baseline, week 2 stress task, Week 3 2-day imaging paradigm, and clinical safety assessments at weeks 2 and 3.
Detailed description
In the R61 trial, two doses of a Phase 3 trial suitable hemp-derived (legal) oral CBD formulation with enhanced bioavailability will be compared against placebo (PBO) in a 3-week double-blind randomized controlled trial. Participants will undergo a standardized stress task at week 2, and a standardized 2-day fear learning and extinction protocol at week 3, with functional MRI (fMRI) brain activation accompanying fear extinction recall and fearful faces tasks on the second day.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Cannabidiol 400mg | Experimental | Drug: CannabidiolParticipants assigned to 200mg twice-daily (400mg/day) dose for 3 weeks. |
| Cannabidiol 800mg | Experimental | Drug: CannabidiolParticipants assigned to 400mg twice-daily (800mg/day) dose for 3 weeks. |
| Placebo | Placebo comparator | Drug: PlaceboParticipants assigned to twice-daily placebo dose for 3 weeks. |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- Male or female outpatients aged 18 to 45 years of age
- A primary mental health complaint (designated by the patient as the most important source of current distress and confirmed on Structured Clinical Interview for DSM-5 diagnoses by a certified clinical evaluator) of Social Anxiety Disorder (SAD), as defined by DSM-5 criteria
- Overall social anxiety severity defined by a Liebowitz Social Anxiety Scale (LSAS) score of at least 60
- Willingness and ability to participate in the informed consent process and comply with the requirements of the study protocol. Includes compliance with the requirements and restrictions listed in ICF and in the protocol (including consent to abstain from using marijuana, any cannabis-related products, or any tobacco products during the study).
Key exclusion criteria (15 listed)
- Known allergy or hypersensitivity to CBD or any of the excipients
- A lifetime history of bipolar disorder, schizophrenia, psychosis, or delusional disorders; obsessive-compulsive disorder or an eating disorder in the past 12 months; neurocognitive disorders, intellectual disabilities, communication disorders or other cognitive dysfunction that could interfere with capacity to engage in therapy or complete study procedures; major depressive disorder, substance or alcohol use disorder (other than nicotine) in the last 6 months.
- Positive urine toxicology for illicit drugs and/or cannabinoids, or self-reported use of CBD, THC or marijuana in the past 4 weeks prior to baseline
- Patients with significant suicidal ideation (assessed by CSSRS SI score greater than 2) or who have enacted suicidal behaviors within 6 months prior to intake will be excluded from study participation and referred for appropriate clinical intervention.
- Patients must be free of concurrent psychotropic medications including antipsychotics, anticonvulsants, benzodiazepines, and opioids, and medications that both have a narrow therapeutic index as determined by the study clinician, and are also substrates or moderate to strong inhibitors of CYP2C9, CYP2C19, CYP3A5, CYP3A7, UGT1A9, UGT2B7, CYP2C8, CYP1A2 or CYP2B6, or are strong inducers of CYP3A4 or CYP2C19, for at least 4 weeks prior to initiation of randomized treatment.
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 |
|---|---|---|
| CannabidiolAlso: Nantheia (A1002N5S) Softgel CapsulesOral Capsule Formulation of CBD dissolved in a self-emulsifying drug technology called nanodomains, encapsulated within 1-ml softgel capsules, with a CBD purity ≥98%. Imported from Ananda Scientific | Drug | Cannabidiol 400mg, Cannabidiol 800mg |
| PlaceboDrug: Placebo Placebo softgel capsule formulation. | Drug | Placebo |
Primary outcome
Change in Stress Task-Induced Anxiety as Measured by Visual Analogue Mood Scale (VAMS)
Time frame: Baseline Phase, Speech Phase (Week 2)
Participants rate their anxiety using the VAMS Anxiety Subscale, which assesses the intensity of anxiety over the previous few minutes. Higher scores indicate greater levels of anxiety. An increase in scores indicates anxiety increased during the observational period.
Difference in Amygdala Beta-Weights in Activation in Response to Intensely Fearful Faces versus Neutral Faces as Measured by fMRI
Time frame: Week 3
Amygdala beta-weights in activation will be measured by functional MRI while viewing both neutral face expression images and intensely fearful face expression images during a Fearful Faces task.
Change in Clinician-Rated Liebowitz Social Anxiety Scale (LSAS) Score
Time frame: Day 1, Week 3
24-item questionnaire ranking Fear or Anxiety and Avoidance in a series of situations. Fear or Anxiety ranked on 4-point Likert scale, where: 0 = None, 1 = Mild, 2 = Moderate, and 3 = Severe. Avoidance ranked on a 4-point Likert scale, where: 0 = Never (0%), 1= Occasionally (1 -33%), 2 = Often (33 - 67%), and 3 = Usually (67 - 100%). Total scores range from 0 to 144; higher scores indicate greater severity of social anxiety: 0-54 = Mild social anxiety; 55-65 = Moderate social anxiety; 66-80 = Marked social anxiety; 81-95 = Severe social anxiety; Greater than 95 = Very severe social phobia (anxiety). An increase in scores indicates severity of social anxiety increased during the observational period.
13 secondary outcomes
Difference in Ventromedial Prefrontal Cortex (vmPFC) Activation Accompanying Fear Extinction Recall During fMRI
Time frame: Week 3
Mean Change in CBD Plasma Concentration from Pre-Treatment to Post-Treatment
Time frame: Immediately Pre-Dose, 60 Minutes Post-Dose (Up to Week 3)
Change in Clinical Global Impression of Severity (CGI-S) Score
Time frame: Day 1, Week 3
Change in Clinical Global Impression of Improvement (CGI-I) Score
Time frame: Day 1, Week 3
Change in Quick Inventory of Depressive Symptomatology, Self-Report (QIDS-SR) Score
Time frame: Day 1, Week 3
Change in Perceived Stress Scale (PSS-10) Score
Time frame: Day 1, Week 3
Change in Anxiety Sensitivity Index-3 (ASI-3) Score
Time frame: Day 1, Week 3
Change in Insomnia Severity Index (ISI) Score
Time frame: Day 1, Week 3
Change in Patient-Reported Outcomes Measurement Information System Ability to Participate in Social Roles and Activities (PROMIS-APS) Score
Time frame: Day 1, Week 3
Change in Patient-Reported Outcomes Measurement Information System Satisfaction with Participation in Social Roles (PROMIS-SPS) Score
Time frame: Day 1, Week 3
Change in Patient-Reported Outcomes Measurement Information System (PROMIS) Anxiety Score
Time frame: Day 1, Week 3
Change in Self-Statements during Public Speaking Scale: Negative Thoughts (SSPS-N) Score
Time frame: Day 1, Week 3
Number of Participants who Adhere to Treatment
Time frame: Up to Week 3
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 7 Jan 2026.
- Individual participant dataSharing planned: Yes. The primary cleaned de-identified dataset will be made available within twelve months of database lock or following publication of primary manuscript, whichever occurs first.
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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.
Naomi Simon, MD principal investigator
NYU Langone Health
Esther Blessing, MD principal investigator
NYU Langone Health
1 site 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 in people with Social Anxiety Disorder, run by NYU Langone Health at 1 site 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 4 inclusion and 15 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 7 Jan 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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?
Change in Stress Task-Induced Anxiety as Measured by Visual Analogue Mood Scale (VAMS) (time frame: Baseline Phase, Speech Phase (Week 2)). The study lists 3 primary outcomes in all. 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 7 Jan 2026.