Acetazolamide for Altitude Sickness

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to test whether the drug Acetazolamide can reduce symptoms of altitude sickness, which includes inflammation and other bodily stress when traveling to high altitudes. Researchers seek to understand how high altitudes affect the body and whether this drug can counteract those effects. Participants will take either Acetazolamide or a placebo (a pill with no active drug) to determine any differences in outcomes. The trial is suitable for healthy non-smokers with no history of altitude-related illnesses who haven't traveled above 8,000 feet in the past month. As an Early Phase 1 trial, this research focuses on understanding how the treatment works in people, offering participants a chance to contribute to groundbreaking research.

Will I have to stop taking my current medications?

Yes, you will need to stop taking any anti-inflammatory medications, steroids, stimulants, or other agents that might affect breathing sensitivity, as these are not allowed during the trial.

Is there any evidence suggesting that Acetazolamide is likely to be safe for humans?

Research has shown that acetazolamide is generally safe for preventing altitude sickness. One study found that taking 125 mg twice daily before climbing can help reduce symptoms. Another study demonstrated that it can lower the risk of sickness at high altitudes by 48% compared to a placebo.

Adults typically take between 500 to 1000 mg daily, but even a lower dose like 125 mg can be effective. Overall, acetazolamide is considered safe for most people when used as directed. Common side effects may include tingling in the fingers and toes, increased urination, and changes in taste. These effects are usually mild and resolve on their own.12345

Why do researchers think this study treatment might be promising?

Most treatments for altitude sickness, like dexamethasone or ibuprofen, work by reducing inflammation or pain. However, acetazolamide is unique because it targets the root cause of altitude sickness by enhancing the body’s ability to acclimate to high altitudes. It does this by promoting better breathing and improving the balance of fluids and electrolytes, helping prevent symptoms before they start. Researchers are excited about acetazolamide because it offers a proactive approach, potentially reducing the severity and onset of altitude sickness symptoms.

What evidence suggests that Acetazolamide might be an effective treatment for altitude sickness?

Studies have shown that acetazolamide effectively prevents acute mountain sickness (AMS) when taken before ascending to high altitudes. For example, one study found that taking 125 mg of acetazolamide twice daily significantly reduced the risk of AMS. Another study confirmed that this dose is more effective than lower doses for prevention. Acetazolamide accelerates the body's adjustment to high altitudes, alleviating symptoms like headaches and nausea. Specifically, 1 in 8 people who take it experience relief from AMS symptoms within 24 hours of reaching high altitude. Overall, research strongly supports using acetazolamide to prevent AMS. Participants in this trial will receive either acetazolamide or a placebo to evaluate its effectiveness in preventing AMS.16789

Are You a Good Fit for This Trial?

This trial is for healthy adults aged 18-65 who do not smoke, are not pregnant, have no heart or lung diseases, no history of severe altitude sickness or sleep apnea, and aren't taking anti-inflammatory drugs. Participants must speak English and haven't been above 8,000 feet in the past month.

Inclusion Criteria

I do not have any serious or recently treated infections.
* Must be fluent in the English language
I am between 18 and 65 years old.
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Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Baseline Testing

Participants complete baseline testing at low altitude, including physiological parameters and ventilatory chemoreflex testing

1 week
1 visit (in-person)

Treatment

Participants receive Acetazolamide or placebo starting 2 days before ascent and continue for 3 days at high altitude

5 days
Daily monitoring at high altitude

Follow-up

Participants are monitored for immune response and acute mountain sickness symptoms after return to baseline elevation

30 days
2 visits (in-person)

What Are the Treatments Tested in This Trial?

Interventions

  • Acetazolamide

Trial Overview

The study tests whether acetazolamide (a pill often used to prevent altitude sickness) can reduce inflammation and immune activation caused by high-altitude exposure. Some participants will get acetazolamide; others will receive a placebo for comparison.

How Is the Trial Designed?

2

Treatment groups

Active Control

Placebo Group

Group I: Acetazolamide treatmentActive Control1 Intervention
Group II: Placebo TreatmentPlacebo Group1 Intervention

Find a Clinic Near You

Who Is Running the Clinical Trial?

University of California, Riverside

Lead Sponsor

Trials
33
Recruited
14,400+

Citations

1.

pubmed.ncbi.nlm.nih.gov

pubmed.ncbi.nlm.nih.gov/32975448/

Altitude, Acute Mountain Sickness, and Acetazolamide

Doses 500-750 mg/day within 24 hours of altitude exposure appear to be the most effective for minimizing symptoms of AMS.

A systematic review and Bayesian network meta-analysis

Moderate-dose acetazolamide (125–250 mg BID) effectively prevents AMS with a longer prophylactic window compared to high-dose regimens (375 mg BID).

Sickness Evaluation at Altitude With Acetazolamide ...

A randomized controlled trial confirmed effectiveness of acetazolamide 125mg twice daily in prevention of AMS when started prior to ascent. In this study, it ...

Efficacy of Acetazolamide for the Prophylaxis of Acute ...

ABSTRACT. Background: Acute mountain sickness (AMS) is a benign and self-limiting syndrome but can progress to life-threatening.

A Randomized Controlled Trial of the Lowest Effective ...

Acetazolamide 62.5 mg twice daily failed to demonstrate equal effectiveness to 125 mg twice daily for prevention of acute mountain sickness.

Acetazolamide for Prevention of Acute Mountain Sickness ...

Acetazolamide likely has multiple effects throughout the body that help to prevent AMS. Both patients and providers should be aware that relief of AMS can come ...

Acetazolamide for the prevention of acute mountain sickness

RESULTS: Acetazolamide prophylaxis was associated with a 48% relative-risk reduction compared to placebo. There was no evidence of an association between ...

Acetazolamide (oral route) - Side effects & dosage

Adults—500 to 1000 milligrams (mg) in divided doses, taken 24 to 48 hours before climbing, then continue for 48 hours while on high altitude or as needed.

High-Altitude Travel and Altitude Illness | Yellow Book

Low risk: Acetazolamide prophylaxis is not indicated. The traveler should carry over-the-counter analgesics for headache and have acetazolamide ...