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NCT03680287 · ClinicalTrials.gov registry record · Phase 2
Effects of Sleep Disruption on Drug Response
A Phase 2 study, sponsored by Johns Hopkins University.
- Completed
- Registry status
- Phase 2
- Development phase
- 109
- Enrollment target
NCT03680287: Completed Phase 2 study, sponsored by Johns Hopkins University.
NCT03680287 is a Phase 2 study that has completed, run by Johns Hopkins University. The registered enrollment target is 109 participants. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03680287, a Phase 2 study, has completed, sponsored by Johns Hopkins University.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 109 participants
- Enrollment target
Study Summary
The central scientific premise of the proposed study is that sleep disruption (SD) will influence individuals' subjective response to blinded medication administration. The investigators further believe these responses will vary among patients who have chronic low back pain (CLBP) vs. healthy controls, and that sex will moderate effects. The proposed study evaluates whether CLBP patients' subjective responses to study medication administration are altered by SD. The investigators focus on two outcome domains: abuse liability (i.e., drug liking and valuation) and response to pain testing. The investigators propose a mixed between-within randomized crossover human-laboratory experiment that investigates placebo-controlled effects of study medication on 1) abuse liability metrics (Drug Liking and Monetary Valuation) and 2) response to laboratory-evoked standardized pain measures, after one night of uninterrupted sleep (US) and again after one night of SD. The investigators will recruit both CLBP patients(\*) and healthy controls (N = 60). (\*) We originally aimed to accrue 60 subjects with CLBP. However, we have been granted approval by the National Institute on Drug Abuse (NIDA) to reduce expectations for the target N for the CLBP cohort. We are no longer expected to recruit N=60 CLBP participants; this is a COVID-19 modification, and we are not required to re-do a power analysis.
Interventions
- DRUG Within-Subject test of blinded study medication
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 109 participants |
| Start Date | 2019-10-07 |
| Est. Completion | 2025-04-29 |
| Phase | Phase 2 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT03680287
The ClinicalTrials.gov registry entry for NCT03680287 describes a study currently listed as completed, categorized as Phase 2. The registered enrollment target is 109 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Johns Hopkins University, which has 1,448 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 1 intervention - of which Within-Subject test of blinded study medication is the first listed.
NCT03680287 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT03680287 about?
NCT03680287 is a clinical study titled "Effects of Sleep Disruption on Drug Response". The central scientific premise of the proposed study is that sleep disruption (SD) will influence individuals' subjective response to blinded medication administration. The investigators further believe these responses will vary among patients who have chronic low back pain (CLBP) vs. healthy contro...
What is the current status of trial NCT03680287?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 109 participants. The study started on 2019-10-07. Estimated completion is 2025-04-29.
What interventions are being tested in trial NCT03680287?
The interventions under investigation include: Within-Subject test of blinded study medication (DRUG).
Who is sponsoring clinical trial NCT03680287?
This trial is sponsored by Johns Hopkins University, which has 1,448 total clinical trials registered on ClinicalTrials.gov.
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