Impacts of Opioids on Respiratory Drive During Sleep

NCT ID: NCT06854211

Last Updated: 2025-03-03

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Clinical Phase: EARLY_PHASE1
• Total Enrollment: 26 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-07-01
• Study Completion Date: 2027-01-31

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)

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: BASIC_SCIENCE
• Blinding Strategy: QUADRUPLE

Study Groups

Morphine

Group Type: ACTIVE_COMPARATOR

Morphine p.o.

Intervention Type: DRUG

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

Placebo

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: DRUG

Placebo will be given on the sleep study night.

Interventions

Morphine p.o.

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

Intervention Type: DRUG

Placebo

Placebo will be given on the sleep study night.

Intervention Type: DRUG

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Brigham and Women's Hospital

OTHER

Sponsor Role: lead

Responsible Party

Danny J. Eckert

Principal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Danny J Eckert, PhD

Role: PRINCIPAL_INVESTIGATOR

Brigham and Women's Hospital

Locations

Brigham and Women's Hospital

Boston, Massachusetts, United States

Countries

United States

Central Contacts

Nicole Calianese

Role: CONTACT

ncalianese@mgb.org

617-732-8977

Facility Contacts

Nicole Calianese

Role: primary

ncalianese@mgb.org

617-732-8977

Other Identifiers

2024P002115

Identifier Type: -

Identifier Source: org_study_id