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NCT04299490 · ClinicalTrials.gov registry record · Phase 2
Effects of Experimental Sleep Disturbances on Receptor Function of Study Drug
A Phase 2 study, sponsored by Johns Hopkins University.
- Completed
- Registry status
- Phase 2
- Development phase
- 148
- Enrollment target
NCT04299490: Completed Phase 2 study, sponsored by Johns Hopkins University.
NCT04299490 is a Phase 2 study that has completed, run by Johns Hopkins University. The registered enrollment target is 148 participants, above the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (11% higher). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT04299490, a Phase 2 study, has completed, sponsored by Johns Hopkins University.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 148 participants
- Enrollment target
Study Summary
The overall goal of this project is to determine whether common sleep disturbance patterns, sleep continuity disturbance (SCD) and Sleep Fragmentation (SF), alter cerebral study drug receptor availability, drug-based analgesia, and drug abuse liability. The investigators specifically aim to: 1) evaluate whether experimental SCD and/or SF alter resting or pain-evoked receptor binding potential in brain regions associated with pain inhibition; 2) examine whether SCD and/or SF alters the analgesic response and abuse liability profile of a study medication; and 3) determine whether receptor binding potentials in brain regions of interest are associated with study medication analgesia and abuse liability. The investigators will also evaluate the extent to which associations differ by sleep condition or sex.
Primary Outcome
The primary dependent measures are the percent change in binding potential of study PET ligand during basal (first 45 minutes) and pain conditions (second 45 minutes) in brain regions of interest. Percent change in binding potential will be assessed between first and second 45 minutes of the 90 minutes assessment session.
Interventions
- BEHAVIORAL Sleep Fragmentation
- DRUG Within-Subject test of blinded study medication (stimulant, benzodiazepine, opioid, cannabinoid, over-the-counter pain medication, or placebo)
- BEHAVIORAL Sleep Continuity Disruption
- BEHAVIORAL Undisturbed Sleep
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 148 participants |
| Start Date | 2020-11-11 |
| Est. Completion | 2025-08-31 |
| Phase | Phase 2 |
What the finished NCT04299490 record still lists
NCT04299490 is an interventional study that assigns participants to a tested intervention. The registered 148 participants enrollment target is mid-sized for trials with a published cap, above the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (11% higher).
The record links to 0 conditions, and to 4 interventions - of which Sleep Fragmentation is the first listed.
NCT04299490 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT04299490 about?
NCT04299490 is a clinical study titled "Effects of Experimental Sleep Disturbances on Receptor Function of Study Drug". The overall goal of this project is to determine whether common sleep disturbance patterns, sleep continuity disturbance (SCD) and Sleep Fragmentation (SF), alter cerebral study drug receptor availability, drug-based analgesia, and drug abuse liability. The investigators specifically aim to: 1) eval...
What is the current status of trial NCT04299490?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 148 participants. The study started on 2020-11-11. Estimated completion is 2025-08-31.
What interventions are being tested in trial NCT04299490?
The interventions under investigation include: Sleep Fragmentation (BEHAVIORAL), Within-Subject test of blinded study medication (stimulant, benzodiazepine, opioid, cannabinoid, over-the-counter pain medication, or placebo) (DRUG), Sleep Continuity Disruption (BEHAVIORAL), Undisturbed Sleep (BEHAVIORAL).
Who is sponsoring clinical trial NCT04299490?
This trial is sponsored by Johns Hopkins University, which has 1,448 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT04299490's enrollment target sits among peer trials
148 491st of 2000 higher than 1,506 of 2,000 other Phase 2 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 2 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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