Last reviewed · How we verify
NCT06656806: CALM
Efficacy and Safety of Inhaled NC-107 As Compared to Placebo After 4 Weeks of Treatment in Patients with Anxiety
EARLY_PHASE1 trial testing Measure concentrations of CBD in spot urine collections from subjects treated with inhaled CBD in Generalized Anxiety Disorder in 40 participants. Not yet recruiting.
1 May 2025
Quick facts
| Lead sponsor | Trinity Hypertension & Metabolic Research Institute |
|---|---|
| Phase | EARLY_PHASE1 |
| Status | Not yet recruiting |
| Study type | INTERVENTIONAL |
| Allocation | non randomized |
| Design | parallel |
| Masking | triple |
| Primary purpose | treatment |
| Enrollment | 40 |
| Start date | 1 December 2024 |
| Primary completion | 1 May 2025 |
| Estimated completion | 1 May 2025 |
| Sites | 1 location across United States |
Drugs / interventions tested
- Measure concentrations of CBD in spot urine collections from subjects treated with inhaled CBD — full drug profile →
- Determine the presence and concentration of CBD in subject's plasma with inhaled CBD — full drug profile →
Conditions studied
- Generalized Anxiety Disorder — all drugs for Generalized Anxiety Disorder →
Sponsor
Trinity Hypertension & Metabolic Research Institute
Who can join
Adults 18 to 80, any sex, with Generalized Anxiety Disorder. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
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.
Publications & conference data
No peer-reviewed publications indexed yet for this trial.
Verify or expand the search:
- PubMed search for NCT06656806
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
Related trials
Other recruiting trials for Generalized Anxiety Disorder
Currently open trials in the same condition.
- NCT06661460 — Internet-Delivered Cognitive Behavioral Intervention for Youths With Anxiety Disorders · NA · recruiting
- NCT06934525 — Implementing Team-Based Treatment for Pediatric Anxiety in Community Mental Health Settings · NA · recruiting
- NCT07305701 — Cohort Study on Medical Students' Mental Health · recruiting
- NCT07330648 — Prospective Clinical Trial of Crisugabalin Capsules in the Treatment of Generalized Anxiety Disorder · Phase 2 · recruiting
- NCT07121712 — Navigated cTBS for the Treatment of Generalized Anxiety Disorder · NA · recruiting
Other Trinity Hypertension & Metabolic Research Institute trials
Trials by the same sponsor.
- NCT05644769 — Chymase Angiotensin-(1-12) Axis In Hypertensive Disease · Phase 4 · unknown
- NCT03826745 — The CHYMASE Angiotensin-(1-12) Axis in Cardiovascular Disease · unknown
- NCT03180593 — Efficacy and Safety of Valsartan and Nebivolol/Valsartan in Hypertensive Patients With LVH · Phase 4 · completed
- NCT03635125 — Efficacy and Safety of Nebivolol Versus Metoprolol in Hypertensive Subject Taking Amlodipine · Phase 4 · completed
Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT06656806 (US National Library of Medicine, public domain)
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by Trinity Hypertension & Metabolic Research Institute
- Last refreshed: 24 October 2024
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT06656806.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing