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

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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