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Sleepless nights may change how your painkillers work

NCT ID NCT04299490

Knowledge-focused Sponsor: Johns Hopkins University Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed This study
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 26, 2026 · Last updated Jun 26, 2026

Summary

This study looks at how disrupted sleep changes the way common drugs (like painkillers, stimulants, and sedatives) work in the body. Researchers will disturb the sleep of 148 healthy adults in a lab and then measure how their brains respond to these drugs, including pain relief and potential for abuse. The goal is to understand if poor sleep makes medications more or less effective or risky.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
sleep fragmentation (behavioral) and various drugs (stimulant, benzodiazepine, opioid, cannabinoid, over-the-counter pain medication, or placebo)
What this could lead to
If successful, this study could help doctors understand how sleep problems change the way painkillers and other drugs work, leading to safer prescribing for people with poor sleep.
What could go wrong
This is a small, early-phase study in healthy volunteers, not patients. The lab-based sleep disruption may not reflect real-world sleep issues, and results may not apply to people with chronic pain or sleep disorders.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 2

Tests whether the treatment actually works, and watches for side effects, in a larger group.

Participants

148 people

The number who actually took part.

Started

Nov 2020

Finished

Aug 2025

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 to 48 years

Sex

Anyone

Healthy volunteers

Accepted

You do not need to have the condition being studied to take part.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: * Healthy, 18-48 year olds meeting criteria for Normal Sleep * Sleep phase within 21:00 and 08:00 * Total sleep time \>6.5 and ≤8.5 hours/night; sleep efficiency ≥85% * Non-smokers/nicotine users * Low caffeine users (≤ 2 cups, q.d.). * Life-time history of exposure to opioids, appropriately prescribed for pain. Exclusion Criteria: * BMI \>35 * Lifetime history of chronic pain * Acute pain * Meet clinical criteria for a sleep disorder * Significant central nervous system disease (e.g., lupus, multiple sclerosis) * Cognitive impairment, brain injury or history of closed head injury with loss of consciousness over 3 mins * Other significant medical or psychiatric morbidity within 6 months or lifetime history of bipolar disorder, psychotic disorder, seizure disorder * Use in the last three months of the following: antidepressants, neuroleptics, sedative hypnotics, isoniazid, glucocorticoids, psychostimulants, opioids * Any contraindicated medical condition * Lifetime history of alcohol or substance used disorder * Clinically significant abnormal complete blood count, hepatic, renal or metabolic panel * Positive toxicology screen for opioids or recreational drugs * Pregnant or lactating women * Significant preadmission psychological distress * Embedded metal objects or fragments or electronic devices in the head or body that would present a risk during MRI * Had exposure to ionizing radiation that in combination with the study's estimated radiation exposure would result in a cumulative exposure, exceeding recommended limits * Unable to tolerate the scanning environment/ claustrophobia

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Conditions

The condition(s) this trial relates to.

agnosia insomnia Pain Parasomnias sleep apnea syndrome sleep disorder sleep-wake disorder

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Healthy Sleep disorder

Contacts and locations

Locations

  • Johns Hopkins School of Medicine

    Baltimore, Maryland, 21224, United States

More trials for these conditions

Other studies related to the condition(s) this trial covers.