Impacts of Opioids on Respiratory Drive During Sleep

NCT06854211 | Not Yet Recruiting Early Phase 1 DMC FDA Drug

• 1 other identifier: 2024P002115
• Study Type: interventional
• Target: 26
• Locations: 1 country
• Sites: 1

Brief Summary

The investigators are studying the impact that opioids have on breathing during sleep in healthy participants and those diagnosed with obstructive sleep apnea.

Conditions

Opioids; Obstructive Sleep Apnea (OSA)

Outcome Measures

Primary Outcomes (1)

• The change in ventilation (L) per minute during stable sleep with morphine versus placebo.

  The primary outcome, determining the change in ventilation in liters per minute, will be analyzed on both subpopulations (controls and people with obstructive sleep apnea) using generalized linear mixed models with treatment, period and sequence as fixed effects and a random effect of participant nested within sequence.

  From enrollment to the end of treatment at 6 weeks.

Study Arms (2)

Morphine

ACTIVE COMPARATOR

Drug: Morphine p.o.

Placebo

PLACEBO COMPARATOR

Drug: Placebo

Interventions

Morphine p.o. DRUG

Morphine 50mg PO will be given on sleep study night.

Morphine

Placebo DRUG

Placebo will be given on the sleep study night.

Placebo

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Healthy controls: Apnea Hypopnea Index (AHI) \< 5 events/hr on in-laboratory PSG within 3 months of enrollment
• OSA group: AHI \> 10 events/hr on in-laboratory PSG within 3 months of enrollment; treated or untreated.

You may not qualify if:

• Sleep disordered breathing or respiratory disorders (other than OSA in the OSA group), such as central sleep apnea (\>50% of respiratory events scored as central), chronic hypoventilation/hypoxemia (awake SaO2 \< 92% by oximetry) due to chronic obstructive pulmonary disease or other respiratory conditions.
• Other sleep disorders: periodic limb movements (periodic limb movement index \> 20/hr), narcolepsy, or parasomnias.
• Any unstable major medical condition.
• Medications expected to stimulate or depress respiration (including other opioids taken at home, barbiturates, benzodiazepines, doxapram, almitrine, theophylline, 4-hydroxybutanoic acid).
• History of allergy to lidocaine or oxymetazoline.
• Contraindications for morphine, including:
• allergy to morphine or opioids
• chronic obstructive pulmonary disease, asthma, or other significant respiratory disorders
• kidney or liver dysfunction, as this can affect the metabolism and excretion of morphine, leading to increased risk of toxicity.
• women who are pregnant or breastfeeding will be excluded due to potential risks to the fetus or infant.
• history of substance abuse, particularly opioid abuse, will be excluded to prevent potential misuse or relapse.
• current use of central nervous system depressants.
• recent head injury, brain tumors, or other conditions leading to increased intracranial pressure.
• unstable heart disease, particularly those with risk factors for or a history of heart rhythm disorders.
• epilepsy or a history of seizures, as morphine can lower the seizure threshold.

Sponsors & Collaborators

• Brigham and Women's Hospital: lead

Study Sites (1)

Brigham and Women's Hospital

Boston, Massachusetts, 02115, United States

Location

MeSH Terms

Conditions

Sleep Apnea, Obstructive

Condition Hierarchy (Ancestors)

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

Study Officials

• Danny J Eckert, PhD

  Brigham and Women's Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Nicole Calianese

CONTACT

617-732-8977; ncalianese@mgb.org

Study Design

• Study Type: interventional
• Phase: early phase 1
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: BASIC SCIENCE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: February 18, 2025
• First Posted: March 3, 2025
• Study Start (Estimated): July 1, 2026
• Primary Completion (Estimated): January 1, 2027
• Study Completion (Estimated): January 31, 2027
• Last Updated: January 29, 2026

Record last verified: 2026-01

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)