Using intranasal midazolam to treat anxiety in palliative care patients

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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 it's running

• Palliativzentrum Bethesda Spital
  Basel, Canton of Basel-City, Switzerland 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
• Inselspital, Universitätsspital Bern
  Bern, Switzerland Not yet recruiting

Study contacts

• Study coordinator: Manuel Haschke, MD
• Email: manuel.haschke@insel.ch
• Phone: +41 (0)31 632 67 93

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

• A playful game to see if it lowers anxiety in palliative care patients

  A serious game called SPAMLO-3.0 is being tested to see if it helps reduce anxiety for people receiving palliative care, compared with standard care.

  Recruiting at 8 sites Centre Hospitalier de Saint-Brieuc · Dinan and 7 other locations · NCT07070869

• Single-session intervention to change ambiguity aversion

  This trial tests whether one brief intervention can change how adults with intolerance of uncertainty and anxiety make ambiguous decisions and how their brains respond.

  Recruiting Northwestern University · Chicago, Illinois · NCT06962527

• Using LSD to help relieve distress in terminally ill patients

  This study is testing if LSD can help reduce pain, anxiety, and depression in people who are terminally ill and improve their overall quality of life.

  Recruiting at 4 sites Phase 2 University Hospital, Basel, Switzerland · Basel and 3 other locations · NCT05883540

• See if preoperative anxiety affects recovery after major digestive cancer surgery

  This study tests whether anxiety before surgery is linked to more complications after major digestive cancer operations in French-speaking adults.

  Recruiting University Hospital, Rouen · Rouen · NCT07897942

• Prehospital end-of-life care: how professionals use a comfort care booklet in Strasbourg

  This study tests how emergency crew members in Strasbourg use a comfort care booklet when caring for patients at end of life, and what they think about it.

  Recruiting University Hospital, Strasbourg, France · Strasbourg · NCT07895940

• Mindful Smartphone Use: A Mindfulness-Based Program for Teens with Sleep and Mood Challenges

  This study tests Mindwire, a mindfulness-based program, to see if it helps teens with problematic phone use who also have depression or anxiety.

  Recruiting Brown University · Providence, Rhode Island · NCT07892807

How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.