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NCT03813121 · ClinicalTrials.gov registry record · Phase 1
The Effects of Sedatives on Tobacco Use Disorder
A Phase 1 study, sponsored by Wake Forest University Health Sciences.
- Completed
- Registry status
- Phase 1
- Development phase
- 10
- Enrollment target
NCT03813121: Completed Phase 1 study, sponsored by Wake Forest University Health Sciences.
NCT03813121 is a Phase 1 study that has completed, run by Wake Forest University Health Sciences. The registered enrollment target is 10 participants, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (83% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03813121, a Phase 1 study, has completed, sponsored by Wake Forest University Health Sciences.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 10 participants
- Enrollment target
Study Summary
This proposal will obtain preliminary data on the effect of a single sub-anesthetic dose of a sedative on cigarette craving and smoking behavior as well as measuring tolerability and acceptability.
Primary Outcome
drug side effects scale: severity scale from 1 (not at all) to 7 (extremely) for symptoms of nausea, dizziness, sleepiness, strange thoughts, hallucinations, confusion, anxiousness, and headache. The average score across all side effects is reported.
Interventions
- DRUG midazolam intravenous infusion
- DRUG placebo intravenous infusion
- DRUG ketamine intravenous infusion
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 10 participants |
| Start Date | 2019-06-01 |
| Est. Completion | 2021-08-31 |
| Phase | Phase 1 |
What the finished NCT03813121 record still lists
NCT03813121 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 10 participants, a relatively small participant target, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (83% lower).
The record links to 0 conditions, and to 3 interventions - of which midazolam intravenous infusion is the first listed.
NCT03813121 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT03813121 about?
NCT03813121 is a clinical study titled "The Effects of Sedatives on Tobacco Use Disorder". This proposal will obtain preliminary data on the effect of a single sub-anesthetic dose of a sedative on cigarette craving and smoking behavior as well as measuring tolerability and acceptability.
What is the current status of trial NCT03813121?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 10 participants. The study started on 2019-06-01. Estimated completion is 2021-08-31.
What interventions are being tested in trial NCT03813121?
The interventions under investigation include: midazolam intravenous infusion (DRUG), placebo intravenous infusion (DRUG), ketamine intravenous infusion (DRUG).
Who is sponsoring clinical trial NCT03813121?
This trial is sponsored by Wake Forest University Health Sciences, which has 1,140 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT03813121's enrollment target sits among peer trials
10 1913th of 2000 higher than 46 of 2,000 other Phase 1 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 1 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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