Impacts of Opioids on Respiratory Drive During Sleep

Early Phase 1

Not yet recruiting

• Conditions: Opioids; Obstructive Sleep Apnea (OSA)
• Interventions: Drug: Morphine p.o.; Drug: Placebo

• Registration Number: NCT06854211
• Lead Sponsor: Brigham and Women's Hospital

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.

Detailed Description

Not available

Study Timeline

• Status Verified: 2025-02
• Study First Submitted: 2025-02-18
• Study First Submitted QC: 2025-02-28
• Last Update Submitted: 2025-02-28
• Study First Posted: 2025-03-03
• Last Update Posted: 2025-03-03
• Study Start: 2025-07-01
• Primary Completion: 2027-01-01
• Study Completion: 2027-01-31

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 26

Inclusion Criteria

• 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.

Exclusion Criteria

• 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.
• individuals with gastrointestinal obstruction. Constipation is not an exclusion criterion because morphine is only administered for one night.
• 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.
• severe psychiatric conditions, particularly those with a history of psychosis, as opioids can exacerbate these conditions.
• medications that interact with morphine, such as selective serotonin reuptake inhibitors (SSRIs), serotonin-norepinephrine reuptake inhibitors (SNRIs), tricyclic antidepressants (TCAs), Monoamine oxidase inhibitors (MAOIs), and the atypical antidepressants buproprion and trazodone.
• untreated or unstable endocrine disorders like adrenal insufficiency or thyroid dysfunction.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Morphine	Morphine p.o.	-
Placebo	Placebo	-

Primary Outcome Measures

Name	Time	Method
The change in ventilation (L) per minute during stable sleep with morphine versus placebo.	From enrollment to the end of treatment at 6 weeks.	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.

Trial Locations

Locations (1)

Brigham and Women's Hospital; 🇺🇸 Boston, Massachusetts, United States