Inhaled NC-107 for Anxiety

(CALM Trial)

Overseen By Henry A Punzi, MD, FCP, FASH

Age: 18+

Sex: Any

Trial Phase: Phase < 1

Sponsor: Trinity Hypertension & Metabolic Research Institute

Disqualifiers: Severe hypertension, Stroke, Heart disease, Diabetes, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 7

Duration: 4 weeks

40 Participants Needed

Trial Summary

What is the purpose of this trial?

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.

Eligibility Criteria

Adults over 18 with moderate generalized anxiety disorder, who can consent to participate and have stable medication regimens. They must not use cannabis regularly or be pregnant/breastfeeding, and agree to use birth control if applicable. Excluded are those with severe hypertension, recent heart issues, significant liver/renal disease, uncontrolled diabetes, severe psychological conditions unrelated to anxiety, drug/alcohol abuse history or participation in another trial recently.

Inclusion Criteria

Negative urine screen for metabolites of THC

Cannabis Naïve or abstinent from regular use (defined as >1x/month) for more than 6 months prior to the baseline visit

Subjects must satisfy all the following criteria to be included in the study

Exclusion Criteria

History of or current use of illicit drugs or alcohol abuse

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

Patients who demonstrate other laboratory test values deviating from the normal range which are considered clinically significant by the investigator

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

1 visit (in-person)

Treatment

Participants receive inhaled NC-107 or placebo for 4 weeks, with questionnaires and blood draws at each visit

4 weeks

4 visits (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

2 visits (in-person)

Treatment Details

Interventions

• NC-107

Trial Overview The trial is testing the effectiveness of an inhaled drug called NC-107 for treating generalized anxiety disorder compared to a placebo. It will assess how well it reduces anxiety severity and examine its safety profile by monitoring medical problems that may arise during treatment. The study also measures how quickly NC-107 enters the bloodstream.

Participant Groups

Group I: Determine the presence and concentration of CBD in Subject's plasma with inhaled CBD Active Control 1 Intervention

Determine the presence and concentration of CBD in the plasma of male and female subjects with generalized anxiety disorder treated with inhaled CBD

Group II: Measure concentrations of CBD is spot urine collections in subjects with inhaled CBD Active Control 1 Intervention

Measure concentration of CBD in spot urine collections in subject's with generalized anxiety disorder treated with inhaled CBD

Who Is Running the Clinical Trial?

Trinity Hypertension & Metabolic Research Institute

Lead Sponsor

Trials

5

Recruited

200+

Nutraceutical Corporation

Collaborator

Trials

2

Recruited

70+