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

Part of paid clinical trials in Carrollton, Texas.

Sponsor
Trinity Hypertension & Metabolic Research Institute
Study ID
NCT06656806
Phase
EARLY_PHASE1
Status
Not Yet Recruiting

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Conditions

  • Generalized Anxiety Disorder

Eligibility Criteria

Sex
ALL
Age
18 Years - 80 Years
Healthy Volunteers
Not accepted

Interventions

  • Measure concentrations of CBD in spot urine collections from subjects treated with inhaled CBD — DRUG
    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 CBD — DRUG
    Determine the presence and concentration of CBD in plasma of subjects with generalized anxiety disorder treated with inhaled CBD

Study Details

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.

Key Dates

Start date
Dec 1, 2024
Status verified
Sep 2024
Primary completion
May 1, 2025
Completion
May 1, 2025

Study Design

Enrollment
40 participants (estimated)
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Active Comparator: Determine the presence and concentration of CBD in Subject's plasma with inhaled CBD
    Determine the presence and concentration of CBD in the plasma of male and female subjects with generalized anxiety disorder treated with inhaled CBD
  • Active Comparator: Measure concentrations of CBD is spot urine collections in subjects with inhaled CBD
    Measure concentration of CBD in spot urine collections in subject's with generalized anxiety disorder treated with inhaled CBD

Primary Outcome Measure

Measure the concentration of CBD in the plasma of subjects [ Time Frame: 4 weeks ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
Punzi Medical CenterCarrolltonTexas75006-

Find similar trials in Carrollton, TX

By research site
Punzi Medical Center· Carrollton, TX

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