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Opioid Antagonist

Study drug naltrexone hydrochloride for Central Sleep Apnea

Phase 4
Waitlist Available
Led By James D Anholm, MD
Research Sponsored by VA Loma Linda Health Care System
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be between 18 and 65 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 60 days
Awards & highlights
Drug Has Already Been Approved
Pivotal Trial

Summary

This trial tests if naltrexone, a medication that blocks brain receptors, can improve sleep quality and breathing patterns at high altitudes. It targets healthy young people without sleep disorders to see if it reduces irregular breathing and improves sleep.

Eligible Conditions
  • Central Sleep Apnea
  • Altitude Sickness

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 60 days
This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 60 days for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Epworth Sleepiness Scale
Groningen Sleep Quality Scale
Nighttime oxygen saturation
+2 more

Awards & Highlights

Drug Has Already Been Approved
The FDA has already approved this drug, and is just seeking more data.
Pivotal Trial
The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.

Trial Design

2Treatment groups
Active Control
Placebo Group
Group I: Study drug naltrexone hydrochlorideActive Control1 Intervention
50 mg Naltrexone PO
Group II: Matching placebo for naltrexone hydrochloridePlacebo Group1 Intervention
Matching placebo for Study Drug Naltrexone

Find a Location

Who is running the clinical trial?

VA Loma Linda Health Care SystemLead Sponsor
9 Previous Clinical Trials
754 Total Patients Enrolled
James D Anholm, MDPrincipal InvestigatorVA Loma Linda Healthcare System
2 Previous Clinical Trials
70 Total Patients Enrolled
~4 spots leftby Nov 2025
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