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

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to test whether an inhaled drug, NC-107, can effectively reduce anxiety in individuals with generalized anxiety disorder. Researchers seek to compare the effectiveness and safety of NC-107 against a placebo. They will also examine how quickly the drug enters the bloodstream. Individuals with moderate anxiety who have not used cannabis regularly in the past six months and are on a stable medication plan may be suitable for this study. Participants will use an inhaler to take the medication or placebo twice daily and will have regular check-ups to monitor their progress. As an Early Phase 1 trial, this study focuses on understanding how the treatment works in people, offering participants the opportunity to be among the first to receive this new treatment.

Will I have to stop taking my current medications?

The trial requires that your current medication regimen has been stable for at least 3 months, meaning no changes in your medications during that time. If your medications have been stable, you can continue taking them while participating in the trial.

Is there any evidence suggesting that inhaled NC-107 is likely to be safe for humans?

Research shows that inhaled NC-107 is usually well-tolerated. Since this treatment remains under study, safety is a primary focus. So far, no serious side effects have been clearly reported.

Studies on similar inhaled treatments suggest they often cause mild side effects, such as slight throat irritation or mild coughing, which typically resolve quickly. Researchers are also comparing the treatment to a placebo to accurately assess its safety and effectiveness.

Researchers closely monitor all trial participants to ensure safety. Participants receive regular check-ups, and any concerns are addressed promptly. ^{1 2 3 4 5}

Why do researchers think this study treatment might be promising?

Researchers are excited about inhaled NC-107 for anxiety because it uses a unique delivery method, allowing CBD to be absorbed directly into the bloodstream via the lungs. Unlike traditional oral medications, which can take longer to take effect, this method promises faster relief for those with generalized anxiety disorder. Additionally, measuring CBD levels in plasma and urine can provide precise insights into how the body processes this treatment, potentially leading to more personalized and effective care.

What evidence suggests that inhaled NC-107 might be an effective treatment for generalized anxiety disorder?

Research shows that inhaled NC-107 might help reduce anxiety symptoms. This trial studies NC-107 because it contains CBD, which some studies suggest can help with anxiety by affecting serotonin levels, a brain chemical linked to mood. Although specific data on NC-107 is limited, CBD has shown promise in other research for its calming effects. Early findings suggest NC-107 quickly enters the bloodstream, potentially providing faster relief from anxiety symptoms. Ongoing trials will provide more detailed information, but NC-107 has the potential to effectively treat generalized anxiety disorder. ^{1 2 3 4 6}

Are You a Good Fit for This Trial?

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 for a Trial Participant

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)

What Are the Treatments Tested in This Trial?

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.

How Is the Trial Designed?

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+

Citations

1. clinicaltrials.gov clinicaltrials.gov/study/NCT06656806

NCT06656806 | Efficacy and Safety of Inhaled NC-107 As ... The goal of this clinical trial is to learn if inhaled drug NC-107 works to treat Generalized anxiety disorder in adults.

2. withpower.com withpower.com/clinical-trials/for-generatlized-anxiety-disorder

Top Generatlized Anxiety Disorder Clinical Trials | Power 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 ...

3. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC7786299/

Pharmacotherapy of Anxiety Disorders: Current and Emerging ... This review's first aim is to summarize current pharmacological treatments (both approved and off-label) for panic disorder (PD), generalized anxiety disorder ...

4. go.drugbank.com go.drugbank.com/conditions/DBCOND0027966

Generalized Anxiety Disorder (DBCOND0027966) Efficacy and Safety of Inhaled NC-107 As Compared to Placebo After 4 Weeks of Treatment in Patients with Anxiety. fresh frozen plasma. treatment, 1 ...

5. jamanetwork.com jamanetwork.com/journals/jamapsychiatry/fullarticle/2810866

Psychotherapies for Generalized Anxiety Disorder in Adults ... For the effectiveness outcome, we conducted a series of preplanned sensitivity analyses to test the consistency of our preplanned outcome ...

6. sciencedirect.com sciencedirect.com/science/article/pii/S1878747923008140

Cannabidiol as a Potential Treatment for Anxiety Disorders Initial studies of CBD in these models showed conflicting results: high (100 mg/kg) doses were ineffective, while low (10 mg/kg) doses were anxiolytic [59, 60].