Intranasal Dexmedetomidine for Acute Anxiety in Adults
Official title: A Multicenter, Randomized, Double-Blind, Placebo-Controlled Clinical Trial Evaluating the Efficacy and Safety of Dexmedetomidine Hydrochloride Nasal Spray for the Treatment of Acute Anxiety States in Adults
Run by Tongji University · NCT07550881 · Data updated 2026-11-12
This study tests whether a nasal spray of dexmedetomidine helps adults with acute anxiety compared with a placebo.
Quick facts
| Phase | Phase 2 |
|---|---|
| Study type | Interventional |
| Ages | 18 Years to 65 Years |
| Sex | All |
| Enrollment | 150 (estimated) |
| Sponsor | Tongji University Academic / other |
| Locations | 1 site (Shanghai, Shanghai Municipality) |
| Status | Recruiting |
| Started | April 30, 2026 |
| Main results expected | December 31, 2026 |
| Study ends | July 31, 2027 |
| Registry record updated | June 10, 2026 |
| Trial ID | NCT07550881 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Adults 18–65 with acute anxiety and at least four accompanying symptoms, plus a CGI-S score of 4 or higher, who can provide informed consent.
✕Probably not a fit
Patients whose anxiety is not primarily responsive to central nervous system sedatives or who meet exclusion criteria may not benefit.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This phase 2, randomized, double-blind, placebo-controlled trial enrolls adults aged 18–65 with acute anxiety who meet predefined criteria. Participants receive either dexmedetomidine hydrochloride nasal spray (30 μg) or an equal-volume placebo, with assessments of anxiety severity and related scales at baseline and multiple time points up to 120 minutes post-dose. Primary aim is to determine safety and initial efficacy in reducing subjective anxiety and related symptoms. The study uses standard inclusion/exclusion criteria to minimize confounding factors and is conducted across multiple hospital sites in China under lead sponsor Tongji University and collaborating centers.
Why it matters
Potential benefit: If successful, the treatment could provide rapid relief of acute anxiety symptoms in adults.
How similar studies have gone: Previous studies in similar contexts have explored intranasal anxiolytics; the efficacy of dexmedetomidine for acute anxiety is being tested in this trial.
Who can join: the full rules
Show full inclusion / exclusion criteria
Inclusion Criteria: 1. No gender restrictions; during screening: age must be between 18 and 65 years; 2. Meet the criteria for acute anxiety, defined as subjective anxiety or worry accompanied by at least four associated symptoms, with a CGI-S score of ≥4; 3. Voluntarily participate in this study and sign an informed consent form. Exclusion Criteria: * 1\. Acute anxiety states caused by other psychoactive substances; history of abuse of psychotropic or anesthetic drugs; 2. Use of sedative-hypnotic drugs at the time of enrollment and still in the washout period; 3. Use of alpha-adrenergic agonists (e.g., norepinephrine, methoxamine, methoxamine hydrochloride, epinephrine, clonidine hydrochloride tablets, midodrine hydrochloride tablets, etc.) or beta-blockers (e.g., metoprolol, etc.) within the past 12 hours; 4. Patients with allergies to the active ingredients or components of the study drugs (e.g., dexmedetomidine) or those with a history of three or more allergic reactions to various allergens; 5. Endocrine system disorders, such as hypoglycemia, pheochromocytoma, hyperthyroidism, or hypothyroidism; 6. Cardiovascular diseases, including myocardial infarction or unstable angina within the 6 months prior to screening; heart rate \<60 beats per minute during screening; History of severe arrhythmias, such as second-degree type II atrioventricular block or higher; poorly controlled blood pressure (hypertension: systolic blood pressure ≥180 mmHg and/or diastolic blood pressure ≥110 mmHg, or hypotension: systolic blood pressure \<90 mmHg and/or diastolic blood pressure ≤50 mmHg); 7. Cerebrovascular diseases, such as a history of ischemic stroke or transient ischemic attack; 8. Respiratory diseases, such as asthma, pulmonary embolism, chronic obstructive pulmonary disease, or pneumonia; history of difficult airway management or assessed potential risk, such as obstructive sleep apnea syndrome or asthma; 9. History of severe hepatic or renal insufficiency; 10. History of epilepsy; 11. Pregnant or lactating women; 12. Other conditions deemed unsuitable for enrollment by the investigator.
Where it's running
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Tongji Hospital Affiliated with Tongji University
Shanghai, Shanghai Municipality, China Recruiting
Study contacts
- Study coordinator: Yuan Shen, MD., Ph.D.
- Email: weiym@smhc.org.cn
- Phone: 86-21-66111243
How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.