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Efficacy and Safety of Inhaled NC-107 As Compared to Placebo After 4 Weeks of Treatment in Patients with Anxiety

NCT06656806 · Status: NOT_YET_RECRUITING · Phase: EARLY_PHASE1 · Type: INTERVENTIONAL · Enrollment: 40

Last updated 2024-10-24

No results posted yet for this study

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 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.

Conditions

  • Generalized Anxiety Disorder

Interventions

DRUG

Measure concentrations of CBD in spot urine collections from subjects treated with inhaled CBD

Measure concentrations of CBD in spot urine collections from subjects with generalized anxiety disorder treated with inhaled CBD

DRUG

Determine the presence and concentration of CBD in subject's plasma with inhaled CBD

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

Sponsors & Collaborators

  • Nutraceutical Corporation

    collaborator UNKNOWN

  • Trinity Hypertension & Metabolic Research Institute

    lead OTHER

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
80 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2024-12-01
Primary Completion
2025-05-01
Completion
2025-05-01
FDA Drug
Yes

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06656806 on ClinicalTrials.gov