Effects of Naltrexone on Nocturnal Breathing Patterns at Altitude

NCT05037032 | Completed Phase 4 FDA Drug

• 1 other identifier: 1392
• Study Type: interventional
• Target: 16
• Locations: 1 country
• Sites: 1

Brief Summary

Sleep at altitude is often poor. The purpose of this study is to evaluate the effects of a single dose of the opioid antagonist, naltrexone, on sleep quality and periodic breathing after rapid ascent to \~3800m altitude.

Conditions

Altitude; Sleep Apnea, Central

Keywords

Altitude; Periodic Breathing; Sleep

Outcome Measures

Primary Outcomes (5)

• Nighttime oxygen saturation

  Change from baseline in nighttime SpO2

  Up to 60 days

• Periodic Breathing

  Change from baseline in portion of night spent with periodic breathing

  Up to 60 days

• Epworth Sleepiness Scale

  Subjective measurement of one's daytime sleepiness (0 = less sleepy, 24= excessively sleepy)

  Up to 60 days

• Stanford Sleepiness Scale

  Self-reported assessments of how alert one is currently feeling (1= wide awake, X=asleep)

  Up to 60 days

• Groningen Sleep Quality Scale

  Assessment to understand sleep quality (0 = good sleep, maximum score of 14 points indicates poor sleep the night before)

  Up to 60 days

Study Arms (2)

Study drug naltrexone hydrochloride

ACTIVE COMPARATOR

50 mg Naltrexone PO

Drug: Naltrexone Pill

Matching placebo for naltrexone hydrochloride

PLACEBO COMPARATOR

Matching placebo for Study Drug Naltrexone

Drug: Placebo

Interventions

Naltrexone Pill DRUG

50 mg PO one-time only

Study drug naltrexone hydrochloride

Placebo DRUG

Matching placebo for naltrexone

Matching placebo for naltrexone hydrochloride

Eligibility Criteria

• Age: 18 Years - 35 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Healthy males or females
• Age 18 to 35 years of age
• Body-mass index (BMI) ≤ 27
• At least two weeks after full vaccination for Sars-CoV-2. Proof of vaccination will be determined by the investigators.

You may not qualify if:

• Current smoker or significant past smoking history (≥ 10 pack-years)
• History of COPD, interstitial lung disease or other pulmonary disease that in the opinion of the investigators would compromise the subject's safety at altitude
• History of obstructive sleep apnea, or other history of sleep disordered breathing, or previous use of nighttime continuous positive airway pressure (CPAP)
• Any history of chronic opioid use or prior abuse history
• Any history of alcohol abuse
• Use of any opioid substance (prescribed or otherwise) within 2-weeks of study enrollment
• Any medications that might, in the opinion of the investigators, interfere with or alter respiratory control, (e.g. acetazolamide). Use of oral contraceptive medications would be allowed as long as the study subject is on the same agent/dose during both arms of the study.
• Recent (within 3 weeks) exposure to altitudes ≥ 3,500 m at time of 1st altitude trip

Sponsors & Collaborators

• VA Loma Linda Health Care System: lead

Study Sites (1)

VA Loma Linda Healthcare System

Loma Linda, California, 92357, United States

Location

MeSH Terms

Conditions

Sleep Apnea, Central

Interventions

Naltrexone

Condition Hierarchy (Ancestors)

Sleep Apnea Syndromes; Apnea; Respiration Disorders; Respiratory Tract Diseases; Sleep Disorders, Intrinsic; Dyssomnias; Sleep Wake Disorders; Nervous System Diseases

Intervention Hierarchy (Ancestors)

Naloxone; Morphinans; Opiate Alkaloids; Alkaloids; Heterocyclic Compounds; Heterocyclic Compounds, Bridged-Ring; Heterocyclic Compounds, 4 or More Rings; Heterocyclic Compounds, Fused-Ring; Phenanthrenes; Polycyclic Aromatic Hydrocarbons; Polycyclic Compounds

Study Officials

• James D Anholm, MD

  VA Loma Linda Healthcare System

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: Randomized double-blind, placebo controlled crossover trial
• Purpose: SUPPORTIVE CARE
• Intervention Model: CROSSOVER
• Sponsor Type: FED
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Staff physician; Pulmonary & Critical Care

Study Record Dates

• First Submitted: August 20, 2021
• First Posted: September 8, 2021
• Study Start: August 8, 2021
• Primary Completion: October 17, 2021
• Study Completion: October 17, 2021
• Last Updated: April 26, 2023

Record last verified: 2023-04

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)