Generalized Anxiety DisorderEarly Phase 1CALMNCT06656806
Efficacy and Safety of Inhaled NC-107 As Compared to Placebo After 4 Weeks of Treatment in Patients with Anxiety
A Early Phase 1 study testing Measure concentrations of CBD in spot urine collections from subjects treated with inhaled CBD and Determine the presence and concentration of CBD in subject's plasma with inhaled CBD in people with Generalized Anxiety Disorder, run by Trinity Hypertension & Metabolic Research Institute at 1 site in United States.
Trial summary
The goal of this clinical trial is to learn if inhaled drug NC-107 works to treat Generalized anxiety disorder in adults. It will also learn about the safety of the drug NC-107. The main questions it aims to answer are: Does the inhaled drug NC-107 decrease the severity of anxiety in participants? What medical… Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Generalized Anxiety Disorder
- What is being tested?
- Measure concentrations of CBD in spot urine collections from subjects treated with inhaled CBD and Determine the presence and concentration of CBD in subject's plasma with inhaled CBD
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Dec 2024to 1 May 2025
- Phase
- Early 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 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Subjects must satisfy all the following criteria to be included in the study
- Capable of reading, comprehending the consent process and providing written informed consent to participate in the study.
- Male or female ≥ 18 years of age with generalized anxiety disorder. This includes a STAI ≥16 (moderate anxiety) or a GAD-7 score ≥10 (moderate anxiety).
- Stable pharmacotherapeutics regimen with no change in the past 3 months.
- Cannabis Naïve or abstinent from regular use (defined as >1x/month) for more than 6 months prior to the baseline visit.
- Negative urine screen for metabolites of THC.
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- Women may be enrolled if all three of the following criteria are met:
- Have a negative urine pregnancy test at screening, for females of childbearing potential.
- Are not breastfeeding
- Do not plan to become pregnant during the study And if one of the following three criteria is met
- Have had a hysterectomy or tubal ligation at least 6 months prior to signing the informed consent form
- Have been postmenopausal for at least 1 year
- Are of childbearing potential and will practice one of the following methods of birth control throughout the study: oral, patch, injectable, or implantable hormone contraception, intrauterine device, diaphragm plus spermicide or female condom plus spermicide.
Who cannot join
- Patients with severe hypertension (mean seated cuff diastolic blood pressure >115 mmHg or mean seated systolic blood pressure >180mmHg) or any form of secondary hypertension at time of screening
- Patients within the past 6 months with a history of hypertensive encephalopathy, stroke, or transient ischemic attack.
- Patients within the last 6 months with a history of myocardial infarction, percutaneous transluminal coronary revascularization, coronary bypass graft, valvular surgery or unstable angina.
- Patients with a history of heart block greater than First Degree Sinoatrial Block. Wolff-Parkinson-White Syndrome, Sick Sinus Syndrome, Atrial Fibrillation, Atrial Flutter, Congestive Heart Failure, or other manifestations of clinically significant cardiac valvular disease.
- Patients with hemo-dynamically significant cardiac valvular disease.
- Patients with evidence of significant chronic renal impairment as indicated by a serum creatinine of > 2.5mg/dL at Screening.
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- Patients with evidence of liver disease as indicated by AST (SGOT) or ALT (SGPT) > 2.5 times or total bilirubin > 1.5 times, the upper limit of the laboratory normal range at Screening.
- Patients who demonstrate other laboratory test values deviating from the normal range which are considered clinically significant by the investigator.
- Patients with insulin and non-insulin dependent diabetes mellitus not controlled on diet, insulin or oral hypoglycemics as defined by a HgA1c >10.5 mg/dcL at Visit 1
- Severe psychological or emotional condition ( Current substance abuse, major depressive, psychotic, and bipolar disorder) that are not associated with Generalized Anxiety Disorder which may interfere with participation in the study.
- History of or current use of illicit drugs or alcohol abuse.
- Participation in a clinical trial and taking any investigational drug within 30 days prior to enrolling into the study (Screening).
- Any other medical condition which, in the Investigator's opinion, may render the patient unable to complete the study or which would interfere with optimal participation in the study or produce significant risk to the patient
- -
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Double-Blind, Placebo-Controlled, Single Center Study to Evaluate the Efficacy and Safety of Inhaled NC-107 As Compared to Placebo After 4 Weeks of Treatment in Patients with Anxiety
The goal of this clinical trial is to learn if inhaled drug NC-107 works to treat Generalized anxiety disorder in adults. It will also learn about the safety of the drug NC-107. The main questions it aims to answer are:
Does the inhaled drug NC-107 decrease the severity of anxiety in participants? What medical problems could participants have when taking drug NC-107? How quickly does NC-107 absorb and get into the blood stream? Researchers will compare drug NC-107 to a placebo (a look-alike substance that contains no drug) to see how effective NC-107 in treating generalized anxiety disorder.
Read more
Participants will be equal to or above 18 years of age and sign an informed consent. They will answer two questionnaires about anxiety and have vitals taken, as well as blood drawn for laboratory results. If a questionnaire reveals moderate anxiety and all blood work is normal the patient will enter the study. The patient will be instructed on the use of an inhaler, that will deliver the medication via the lung. Two puffs twice daily of NC-107 or placebo will be used during the remainder of the study.
Blood will be drawn for peak and trough levels of NC-107. Questionnaires will be completed at each visit.
- Conditions
- Generalized Anxiety Disorder
- Being tested
- Measure concentrations of CBD in spot urine collections from subjects treated with inhaled CBD, Determine the presence and concentration of CBD in subject's plasma with inhaled CBD
- Keywords
- Generalized anxiety disorder, CBD, Metered dose inhaler
- Medical subject headings
- Generalized Anxiety Disorder
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Measure concentrations of CBD in spot urine collections from subjects treated with inhaled CBDDrug
Measure concentrations of CBD in spot urine collections from subjects with generalized anxiety disorder treated with inhaled CBD
Determine the presence and concentration of CBD in subject's plasma with inhaled CBDDrug
Determine the presence and concentration of CBD in plasma of subjects with generalized anxiety disorder treated with inhaled CBD
| Study group | Role | What they receive |
|---|---|---|
| Determine the presence and concentration of CBD in Subject's plasma with inhaled CBD | Active comparator | Determine the presence and concentration of CBD in the plasma of male and female subjects with generalized anxiety disorder treated with inhaled CBD Receives: Drug: Determine the presence and concentration of CBD in subject's plasma with inhaled CBD |
| Measure concentrations of CBD is spot urine collections in subjects with inhaled CBD | Active comparator | Measure concentration of CBD in spot urine collections in subject's with generalized anxiety disorder treated with inhaled CBD Receives: Drug: Measure concentrations of CBD in spot urine collections from subjects treated with inhaled CBD |
What is being measured
The primary outcome is the main question the study is designed to answer.
Measure the concentration of CBD in the plasma of subjects
Measure the concentration of CBD in the plasma of male and female subjects with Generalized Anxiety Disorder treated with inhaled CBD.
Measured: 4 weeks
Secondary outcomes (1)
Concentrations of CBD in spot urine collections.
Measure concentrations of CBD in spot urine collections from male and female subjects with Generalized Anxiety Disorder treated with inhaled CBD.
Measured: 4 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Oct 2024
- Study start1 Dec 2024 (estimated)
- Primary completion1 May 2025 (estimated)
- Study completion1 May 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Generalized 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
- Early Phase 1
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Model description
- Double blinded Parallel Study
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Trinity Hypertension & Metabolic Research Institute
- Sponsor type
- University, hospital or other
- Collaborators
- Nutraceutical Corporation
- Responsible party
- Principal investigator, Henry Anthony Punzi, Trinity Hypertension & Metabolic Research Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06656806
- Sponsor's protocol ID
- NC-65-002
- Acronym
- CALM
- Status last verified
- Sep 2024
- First submitted
- 18 Sep 2024
- Last updated
- 24 Oct 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No: Phase 1 clinical trial
Study at a glance
From the registry record, last updated by the sponsor on 24 Oct 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Double-Blind, Placebo-Controlled, Single Center Study to Evaluate the Efficacy and Safety of Inhaled NC-107 As Compared to Placebo After 4 Weeks of Treatment in Patients with Anxiety
- ClinicalTrials.gov ID
- NCT06656806
- Acronym / sponsor ID
- CALM / NC-65-002
- Conditions
- Generalized Anxiety Disorder
- Keywords
- Generalized anxiety disorder, CBD, Metered dose inhaler
- Phase
- Early Phase 1
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Trinity Hypertension & Metabolic Research InstituteUniversity, hospital or other
- Collaborators
- Nutraceutical Corporation
- Study start
- 1 Dec 2024 (estimated)
- Primary completion
- 1 May 2025 (estimated)
- Study completion
- 1 May 2025 (estimated)
- First posted
- 24 Oct 2024 (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 goal of this clinical trial is to learn if inhaled drug NC-107 works to treat Generalized anxiety disorder in adults. It will also learn about the safety of the drug NC-107. The main questions it aims to answer are:
Does the inhaled drug NC-107 decrease the severity of anxiety in participants? What medical problems could participants have when taking drug NC-107? How quickly does NC-107 absorb and get into the blood stream? Researchers will compare drug NC-107 to a placebo (a look-alike substance that contains no drug) to see how effective NC-107 in treating generalized anxiety disorder.
Participants will be equal to or above 18 years of age and sign an informed consent. They will answer two questionnaires about anxiety and have vitals taken, as well as blood drawn for laboratory results. If a questionnaire reveals moderate anxiety and all blood work is normal the patient will enter the study. The patient will be instructed on the use of an inhaler, that will deliver the medication via the lung. Two puffs twice daily of NC-107 or placebo will be used during the remainder of the study.
Blood will be drawn for peak and trough levels of NC-107. Questionnaires will be completed at each visit.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
- Model description
- Double blinded Parallel Study
| Arm | Type | Receives |
|---|---|---|
| Determine the presence and concentration of CBD in Subject's plasma with inhaled CBD | Active comparator | Drug: Determine the presence and concentration of CBD in subject's plasma with inhaled CBDDetermine the presence and concentration of CBD in the plasma of male and female subjects with generalized anxiety disorder treated with inhaled CBD |
| Measure concentrations of CBD is spot urine collections in subjects with inhaled CBD | Active comparator | Drug: Measure concentrations of CBD in spot urine collections from subjects treated with inhaled CBDMeasure concentration of CBD in spot urine collections in subject's with generalized anxiety disorder treated with inhaled CBD |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (13 listed)
- Subjects must satisfy all the following criteria to be included in the study
- Capable of reading, comprehending the consent process and providing written informed consent to participate in the study.
- Male or female ≥ 18 years of age with generalized anxiety disorder. This includes a STAI ≥16 (moderate anxiety) or a GAD-7 score ≥10 (moderate anxiety).
- Stable pharmacotherapeutics regimen with no change in the past 3 months.
- Cannabis Naïve or abstinent from regular use (defined as >1x/month) for more than 6 months prior to the baseline visit.
Key exclusion criteria (14 listed)
- Patients with severe hypertension (mean seated cuff diastolic blood pressure >115 mmHg or mean seated systolic blood pressure >180mmHg) or any form of secondary hypertension at time of screening
- Patients within the past 6 months with a history of hypertensive encephalopathy, stroke, or transient ischemic attack.
- Patients within the last 6 months with a history of myocardial infarction, percutaneous transluminal coronary revascularization, coronary bypass graft, valvular surgery or unstable angina.
- Patients with a history of heart block greater than First Degree Sinoatrial Block. Wolff-Parkinson-White Syndrome, Sick Sinus Syndrome, Atrial Fibrillation, Atrial Flutter, Congestive Heart Failure, or other manifestations of clinically significant cardiac valvular disease.
- Patients with hemo-dynamically significant cardiac valvular disease.
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 |
|---|---|---|
| Measure concentrations of CBD in spot urine collections from subjects treated with inhaled CBDMeasure concentrations of CBD in spot urine collections from subjects with generalized anxiety disorder treated with inhaled CBD | Drug | Measure concentrations of CBD is spot urine collections in subjects with inhaled CBD |
| Determine the presence and concentration of CBD in subject's plasma with inhaled CBDDetermine the presence and concentration of CBD in plasma of subjects with generalized anxiety disorder treated with inhaled CBD | Drug | Determine the presence and concentration of CBD in Subject's plasma with inhaled CBD |
Primary outcome
Measure the concentration of CBD in the plasma of subjects
Time frame: 4 weeks
Measure the concentration of CBD in the plasma of male and female subjects with Generalized Anxiety Disorder treated with inhaled CBD.
1 secondary outcome
Concentrations of CBD in spot urine collections.
Time frame: 4 weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Oct 2024.
- Individual participant dataSharing planned: No. Phase 1 clinical trial
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Early Phase 1 study testing Measure concentrations of CBD in spot urine collections from subjects treated with inhaled CBD and Determine the presence and concentration of CBD in subject's plasma with inhaled CBD in people with Generalized Anxiety Disorder, run by Trinity Hypertension & Metabolic Research Institute 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 13 inclusion and 14 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: status not confirmed, as of the sponsor's last update on 24 Oct 2024. 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. 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?
Early Phase 1 (sometimes called Phase 0) studies give a very small amount of a treatment to a few people, mainly to see how the body handles it.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Henry A Punzi, MD, FCP, FASH (9724787700, punzimedcenter@aol.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Measure the concentration of CBD in the plasma of subjects (time frame: 4 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 24 Oct 2024.