Efficacy and Safety of Inhaled NC-107 As Compared to Placebo After 4 Weeks of Treatment in Patients with Anxiety (CALM)
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.
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 Overview
Status
Conditions
Study Type
Enrollment (Estimated)
Phase
- Early Phase 1
Contacts and Locations
Study Contact
- Name: Henry A Punzi, MD, FCP, FASH
- Phone Number: 9724787700
- Email: punzimedcenter@aol.com
Study Locations
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Texas
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Carrollton, Texas, United States, 75006
- Punzi Medical Center
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria
Inclusion Criteria:
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.
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.
Exclusion Criteria:
- 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.
- 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
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Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Non-Randomized
- Interventional Model: Parallel Assignment
- Masking: Triple
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
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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
|
Determine the presence and concentration of CBD in plasma of 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
|
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
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
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.
|
4 weeks
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Concentrations of CBD in spot urine collections.
Time Frame: 4 weeks
|
Measure concentrations of CBD in spot urine collections from male and female subjects with Generalized Anxiety Disorder treated with inhaled CBD.
|
4 weeks
|
Other Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Decrease in the levels of Anxiety with Questionnaires
Time Frame: 4 weeks
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Whether there is a decrease in the levels of anxiety in the STAI and or GAD-7 questionnaires at weeks 1, 2, 3, and 4, when compared to baseline week 0.
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4 weeks
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Collaborators and Investigators
Collaborators
Study record dates
Study Major Dates
Study Start (Estimated)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- NC-65-002
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
product manufactured in and exported from the U.S.
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