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NCT Number: NCT06854211

Impacts of Opioids on Respiratory Drive During Sleep

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

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Key information

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Early Phase 1

Primary location

Brigham and Women's Hospital

Boston, Massachusetts, 02115, United States

Location contact

Danny J Eckert, PhD

PRINCIPAL_INVESTIGATOR

Nicole Calianese

CONTACT

[email protected]

617-732-8977

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Morphine p.o.

Drug

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

Placebo

Drug

Placebo will be given on the sleep study night.

Primary outcomes

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

    Time frame: 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.

Study contacts

Contact information is provided by the study sponsor or research team.

Nicole Calianese

CONTACT

[email protected]

617-732-8977

Sponsors and collaborators

Lead sponsor

Brigham and Women's Hospital

Other

Registry information

Official study title

Mechanisms of Opioid-induced Respiratory Depression (OIRD) During Sleep

Acronym: OIRD

Important dates

Study start
2026
Primary completion
2027
Study completion
2027
First posted
Mar 3, 2025
Registry last updated
Jan 29, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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