Medical Information Only. Always consult your healthcare provider before enrolling in any clinical trial.
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, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (18% lower). 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.
Primary Outcome
Visual Analog Scale (0-100), where 0=None and 100 = Extremely , in response to the question, "Do you like the drug?"
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 |
What the finished NCT03680287 record still lists
NCT03680287 is an interventional study that assigns participants to a tested intervention. The registered 109 participants enrollment target is mid-sized for trials with a published cap, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (18% lower).
The record links to 0 conditions, and to 1 intervention - of which Within-Subject test of blinded study medication is the first listed.
NCT03680287 does not publish any study locations in the registry export this page uses.
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.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT03680287's enrollment target sits among peer trials
109 640th of 2000 higher than 1,361 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
Nationwide trials with similar profiles
Cross-condition peers matched on enrollment target and registry start date, not the same-condition list above.
Similar enrollment target
- NCT02421380 · 109 participants · NA
Characterization of Hyperpolarized Pyruvate MRI Reproducibility
- NCT04526600 · 109 participants · NA
Fidgeting and Attentional and Emotional Regulation in ADHD
- NCT04835584 · 109 participants · Phase 1
KRT-232 and TKI Study in Chronic Myeloid Leukemia
- NCT06626516 · 109 participants · Phase 1
Tebentafusp-tebn With LDT in Metastatic UM
Similar registry start date
- NCT05962346 · started 2026-12 · NA
Fetal Endoscopic Tracheal Occlusion for Congenital Diaphragmatic Hernia
- NCT07125183 · started 2026-12 · Phase 2
Study on Efficacy and Tolerability of Weekly Doxorubicin in Elderly Patients With Advanced or Metastatic Leiomyosarcoma
- NCT07292298 · started 2026-11 · Phase 2
Phase 2 Single-Arm Rectal Cancer Brachytherapy for Patients With Low-Lying Residual Adenocarcinoma After Total Neoadjuvant Therapy to Improve Organ Preservation Rates
- NCT04263285 · started 2026-10 · NA
Treatment of Depression Post-SCI