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Cannabinoid Therapy
Inhaled NC-107 for Anxiety (CALM Trial)
Phase < 1
Waitlist Available
Research Sponsored by Trinity Hypertension & Metabolic Research Institute
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
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
Must not have
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 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
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 4 weeks
Awards & highlights
No Placebo-Only Group
Summary
This trial aims to see if an inhaled drug called NC-107 can effectively treat Generalized Anxiety Disorder in adults. The trial will also assess the safety of NC-107 and how quickly it is
Who is the study for?
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.
What is being tested?
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.
What are the potential side effects?
Potential side effects of NC-107 are not explicitly listed but generally could include reactions at the inhalation site, changes in mood or behavior given its target on anxiety disorders, possible impact on blood pressure or heart rate due to inhalation delivery method.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I am 18 or older with moderate anxiety confirmed by tests.
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My medication has not changed in the last 3 months.
Exclusion Criteria
You may be eligible for the trial if you check “No” for criteria below:Select...
My liver tests are within normal limits.
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My diabetes is not well-controlled, with an HgA1c level over 10.5.
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I do not have severe high blood pressure or secondary hypertension.
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I have not had a heart attack or heart surgery in the last 6 months.
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I have a history of serious heart conditions.
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I have a serious heart valve problem.
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My kidney function is normal, with a creatinine level at or below 2.5mg/dL.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 4 weeks
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~4 weeks
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Measure the concentration of CBD in the plasma of subjects
Secondary study objectives
Concentrations of CBD in spot urine collections.
Other study objectives
Decrease in the levels of Anxiety with Questionnaires
Awards & Highlights
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
Trial Design
2Treatment groups
Active Control
Group I: Determine the presence and concentration of CBD in Subject's plasma with inhaled CBDActive Control1 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 CBDActive Control1 Intervention
Measure concentration of CBD in spot urine collections in subject's with generalized anxiety disorder treated with inhaled CBD
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Who is running the clinical trial?
Trinity Hypertension & Metabolic Research InstituteLead Sponsor
4 Previous Clinical Trials
155 Total Patients Enrolled
Nutraceutical CorporationUNKNOWN
1 Previous Clinical Trials
25 Total Patients Enrolled