Using intranasal midazolam to treat anxiety in palliative care patients
Administration of Intranasal Midazolam for Anxiety in Palliative Care - a Double-blind, Randomized, Placebo-controlled Multicenter Exploratory Pilot Study With a Nested Pharmacokinetic Analysis
This study is testing whether a nasal spray of midazolam can help reduce anxiety in patients receiving palliative care.
Quick facts
| Phase | Phase 2 |
|---|---|
| Study type | Interventional |
| Enrollment | 36 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Insel Gruppe AG, University Hospital Bern Academic / other |
| Locations | 5 sites (Basel, Canton of Basel-City and 4 other locations) |
| Trial ID | NCT06330584 on ClinicalTrials.gov |
What this trial studies
This pilot study aims to evaluate the effects and safety of different doses of intranasal midazolam in treating acute anxiety among hospitalized palliative care patients. It is a double-blind, randomized, placebo-controlled trial involving three study arms, with a total of 36 participants. The primary outcome is the change in patient-reported anxiety levels, while secondary outcomes include the time until additional doses are requested and various physiological measures. Participants will be monitored for adverse events and pharmacokinetic data will be collected from those with venous access.
Who should consider this trial
Good fit: Ideal candidates are adult palliative care patients experiencing acute anxiety who are hospitalized and have a clinical indication for midazolam.
Not a fit: Patients prescribed midazolam for seizures or continuous sedation, or those with a history of allergy to midazolam, may not benefit from this study.
Why it matters
Potential benefit: If successful, this treatment could provide rapid relief from acute anxiety for patients in palliative care, improving their quality of life.
How similar studies have performed: While the use of midazolam for anxiety is established, this specific approach using intranasal administration in palliative care is novel and has not been extensively tested.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Adult palliative care patients (≥ 18 years) hospitalized at one of the study sites * Self-reported acute anxiety with clinical indication for intranasal midazolam administration according to attending physician * Patient willing and able to provide written informed consent * Informed consent as documented by signature * Patient willing and able to complete anxiety assessment * Additionally for nested pharmacokinetic analysis: Patients with available central or peripheral venous access, i.e., peripheral venous catheter (PVC), central venous catheter (CVC), peripherally inserted central venous catheter (PICC) line, midline catheter, or PORT-A-CATH® (PAC), and patient willing and able to provide blood samples Exclusion Criteria: * Intranasal midazolam prescribed for seizures * Midazolam (any route of administration) prescribed and administered for continuous sedation * History of allergy or hypersensitivity to midazolam * History of benzodiazepine-related paradoxical reaction to midazolam * Acute narrow-angle glaucoma * Impaired nasal absorption (e.g., nasogastric tube, nasal obstruction, nasal polyps, etc.) * Intranasal midazolam within 24 h before study enrollment * Time between informed general consent for study participation through investigators and planned midazolam administration \< 24 h * Co-medication with strong CYP3A4 inducers or inhibitors according to pre-defined list (FDA) * Recently initiated therapy with strong opioids (i.e., within past 5 days) * Co-medication with other CNS depressants causing clinically relevant degree of sedation * Inability to follow the procedures of the study (i.e., provision of Informed Consent, completion of assessment tool, e.g., due to language problems or dementia)
Where this trial is running
Basel, Canton of Basel-City and 4 other locations
- Palliativzentrum Bethesda Spital — Basel, Canton of Basel-City, Switzerland (Recruiting)
- Inselspital, Universitätsspital Bern — Bern, Switzerland (Not_yet_recruiting)
- Universitäres Zentrum für Palliative Care (UZP) — Bern, Switzerland (Recruiting)
- Zentrum für Palliative Care, Stadtspital Zürich — Zurich, Switzerland (Recruiting)
- Kompetenzzentrum Palliative Care, Universitätsspital Zürich — Zurich, Switzerland (Recruiting)
Study contacts
- Study coordinator: Manuel Haschke, MD
- Email: manuel.haschke@insel.ch
- Phone: +41 (0)31 632 67 93
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.