Apply to Trial

Compensation: Varies

Number of Visits: Unknown

Duration: 6 weeks

26 Participants Needed

Morphine for Obstructive Sleep Apnea
(OIRD Trial)

Overseen ByDanny J Eckert, PhD

Age: 18+

Sex: Any

Trial Phase: Phase < 1

Sponsor: Brigham and Women's Hospital

Must not be taking: Opioids, Barbiturates, Benzodiazepines, others

Disqualifiers: Respiratory disorders, Pregnancy, Substance abuse, others

Trial Summary

Will I have to stop taking my current medications?

Yes, you may need to stop taking certain medications. The trial excludes participants using medications that affect breathing, such as other opioids, barbiturates, benzodiazepines, and some antidepressants. It's important to discuss your current medications with the trial team to see if any changes are needed.

What data supports the effectiveness of the drug morphine for obstructive sleep apnea?

Some studies suggest that morphine may improve certain aspects of obstructive sleep apnea (OSA) by affecting breathing reflexes, but results vary widely among individuals. However, other research indicates that morphine does not significantly change key sleep and respiratory outcomes in OSA patients compared to a placebo.¹ ² ³ ⁴ ⁵

Is morphine generally safe for humans?

The research articles provided do not contain specific safety data about morphine for obstructive sleep apnea or other conditions.⁶ ⁷ ⁸ ⁹ ¹⁰

How does the drug morphine differ from other treatments for obstructive sleep apnea?

Morphine is unique in its potential to improve obstructive sleep apnea (OSA) by modulating chemoreflexes, despite the common belief that opioids worsen OSA. Unlike other treatments, morphine's effect on OSA shows significant variability among individuals, possibly due to differences in how people metabolize the drug.¹ ² ³ ⁴ ¹¹

What is the purpose of this trial?

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

Research Team

Danny J Eckert, PhD

Principal Investigator

Brigham and Women's Hospital

Eligibility Criteria

This trial is for healthy individuals and those with obstructive sleep apnea to study how opioids affect their breathing during sleep. Specific eligibility criteria are not provided, but typically include age range, health status, and absence of conditions that could interfere with the study.

Inclusion Criteria

Healthy controls: Apnea Hypopnea Index (AHI) < 5 events/hr on in-laboratory PSG within 3 months of enrollment

I have moderate to severe sleep apnea diagnosed within the last 3 months.

Exclusion Criteria

I have epilepsy or a history of seizures.

I have been diagnosed with a sleep disorder like restless legs, narcolepsy, or unusual behaviors during sleep.

History of allergy to lidocaine or oxymetazoline

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Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive either morphine or placebo to study the impact on respiratory drive during sleep

6 weeks

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

Treatment Details

Interventions

Morphine

Trial Overview The trial is testing the effects of Morphine taken orally (p.o.) compared to a placebo on respiratory drive during sleep in participants. It aims to understand the impacts of opioids on people with and without sleep apnea.

Participant Groups

2Treatment groups

Active Control

Placebo Group

Group I: MorphineActive Control1 Intervention

Group II: PlaceboPlacebo Group1 Intervention

Find a Clinic Near You

Who Is Running the Clinical Trial?

Brigham and Women's Hospital

Lead Sponsor

Trials

1,694

Recruited

14,790,000+

Findings from Research

The safety profile of medications can change after they are approved for public use, as new safety issues may arise that were not identified during clinical trials.

Regulatory agencies, like the FDA, actively monitor medication safety through various methods, including analyzing adverse experience reports and using large electronic databases to detect potential safety signals.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Monitoring product safety in the postmarketing environment.Sharrar, RG., Dieck, GS.[2021]

Effective clinical drug safety surveillance is crucial for protecting public health and ensuring the commercial success of pharmaceutical products, as it helps monitor and manage adverse drug events.

The process of drug safety surveillance is governed by FDA regulations and involves systematic management of adverse event reports, emphasizing the importance of clear communication and data handling to improve drug safety outcomes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A primer of drug safety surveillance: an industry perspective. Part I: Information flow, new drug development, and federal regulations.Allan, MC.[2019]