Prochlorperazine Maleate Versus Placebo for the Prophylaxis of Acute Mountain Sickness

Completed · Phase 2 · Has a placebo group

Conditions studied: Acute Mountain Sickness

In brief

This study is a trial looking at a drug to help prevent acute mountain sickness. The drug is prochlorperazine, a drug commonly used to treat nausea vomiting and headache. Participants will either take the drug or a placebo, and hike to and sleep at the summit of Mount Blue Sky located at 4,348 meters (14,265 feet).

Key facts

Study ID

NCT06450899

Run by

University of Colorado, Denver

People needed

57

Starts

2024-08-05

Expected to finish

2024-08-28

Last updated by the study team

2024-09-19

Who can join

Age: 18 and older, up to 75. Sex: any. Healthy volunteers: accepted.

You may qualify if…

• Adults >18 years old.

You may not qualify if…

• Individuals <18 years old or >75 years old
• Pregnant women
• Individuals who reside at or have slept at elevations >1,800 meters in the last two weeks
• Individuals having taken acetazolamide, steroids, ibuprofen, anti-emetics or additional analgesics within the last 24 hours prior to study initiation
• Individuals requiring supplemental baseline oxygen or with chronic disorders known to be significantly impacted by hypoxia
• Individuals with known allergies to prochlorperazine or phenothiazines
• Individuals taking medications with significant medication interactions with prochlorperazine: Dofetilide, potassium acid phosphate, potassium chloride, potassium citrate, potassium phosphate, Yohimbe.
• Individuals with a history of dementia
• Individuals who lack decision making capacity

Where it is running

• Mount Blue Sky — Evergreen, Colorado, United States

Full record on ClinicalTrials.gov

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