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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

Study Summary

This trial found that naltrexone may improve sleep quality and decrease periodic breathing at high altitudes.

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

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

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
759 Total Patients Enrolled
James D Anholm, MDPrincipal InvestigatorVA Loma Linda Healthcare System
2 Previous Clinical Trials
70 Total Patients Enrolled

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

What is the participant capacity of this clinical trial?

"Affirmative. Clinicaltrials.gov data reveals that enrollment for this experiment, which was first posted on August 8th 2021, is still open at the moment. 30 test subjects need to be selected from 1 site in total."

Answered by AI

Has there been any prior research involving the use of naltrexone hydrochloride?

"Presently, 12 studies researching naltrexone hydrochloride are in Phase 3 trials and 46 experiments remain active. The majority of tests for this drug occur in New york City but the reach extends to 161 clinical centres across America."

Answered by AI

What are the typical applications of naltrexone hydrochloride?

"Naltrexone hydrochloride is usually prescribed to help with long-term weight management, but can also be used as an adjunct treatment for pain, increased physical activity and diet modification."

Answered by AI

Are any seniors eligible to partake in this research study?

"This trial is only available to patients between the ages of 18 and 35. Conversely, there are 21 studies that cater to minors while 120 trials are geared towards seniors aged 65 or above."

Answered by AI

Is enrollment still open in this scientific investigation?

"Affirmative. Details available on the clinicaltrials.gov website demonstrate that this medical trial, which commenced recruitment on August 8th 2021 is still recruiting participants. Thirty individuals are needed from a single location for participation in the study."

Answered by AI

Which individuals are eligible to join this research program?

"This clinical study is looking for 30 individuals with a diagnosis of obstructive sleep apnea, residing between ages 18 and 35. To be eligible to participate, candidates must have completed their vaccine regimen against Sars-CoV-2 at least 14 days prior, as confirmed by the investigators. Further criteria include healthy males or females; BMI no greater than 27."

Answered by AI

What risks have been associated with the use of naltrexone hydrochloride?

"Our team has assessed the safety of Study drug naltrexone hydrochloride to be a 3, given that it is currently in Phase 4 clinical trials and thus approved for use."

Answered by AI
Recent research and studies
clinicaltrials.govStudy
Effects of Naltrexone on Nocturnal Breathing Patterns at Altitude
James D. Anholm, M.D. 2021. "Effects of Naltrexone on Nocturnal Breathing Patterns at Altitude". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05037032.
~4 spots leftby Apr 2025
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