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NCT04055467 · ClinicalTrials.gov registry record · Phase 1
Brain Imaging in Tobacco Smokers During a Quit Attempt
A Phase 1 study of Tobacco Use Disorder and Tobacco Smoking, sponsored by Johns Hopkins University.
- Completed
- Registry status
- Phase 1
- Development phase
- 15
- Enrollment target
- 1
- Study location
NCT04055467 is a Phase 1 study of Tobacco Use Disorder and Tobacco Smoking that has completed, run by Johns Hopkins University. The registered enrollment target is 15 participants, below the 239-participant average among 70 other Tobacco Use Disorder trials with a reported enrollment target (94% lower). The trial reports 1 study location across 1 state.
The verdict
NCT04055467, a Phase 1 study of Tobacco Use Disorder and Tobacco Smoking, has completed, sponsored by Johns Hopkins University.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 15 participants
- Enrollment target
- 1
- Study location
Study Summary
The proposed study will help fill gaps in existing research by determining if nicotine-dependent cigarette smokers show changes in α7 nicotinic acetylcholine receptor (nAChR) availability when compared to matched historical controls using positron emission tomography (PET) imaging and the radioactive ligand \[18F\]-ASEM (3-(1,4-diazabicyclo\[3.2.2\]nonan-4-yl)-6 \[18F\]fluorodibenzo\[b,d\]thiophene 5,5-dioxide), an α7 nAChR antagonist. The study will also explore whether α7 nAChR availability influences clinically relevant measures of tobacco abstinence (e.g., withdrawal and craving, cognitive impairment), self-reported cigarettes per day, and time to relapse during an 8-day quit attempt during which smokers can receive escalating payments contingent upon providing objective evidence (breath CO and urinary cotinine) of smoking abstinence.
Conditions Studied
Interventions
- BEHAVIORAL Contingency Management
- DRUG [F18]-ASEM (3-(1,4-diazabicyclo[3.2.2]nonan-4-yl)-6-[18F]fluorodibenzo[b,d]thiophene 5,5-dioxide)
Study Locations (1)
Maryland
- Elise Weerts - Baltimore
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 15 participants |
| Start Date | 2019-12-16 |
| Est. Completion | 2022-11-30 |
| Phase | Phase 1 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT04055467
The ClinicalTrials.gov registry entry for NCT04055467 describes a study currently listed as completed, categorized as Phase 1. The registered enrollment target is 15 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 239-participant average among 70 other Tobacco Use Disorder trials with a reported enrollment target (94% lower). The listed sponsor is Johns Hopkins University, which has 1,448 total studies on file at ClinicalTrials.gov.
The record links to 2 conditions, with Tobacco Use Disorder appearing as the primary indexed condition, and to 2 interventions - of which Contingency Management is the first listed.
NCT04055467 reports 1 study location spanning 1 distinct geographic area - top geographies include Maryland.
Frequently Asked Questions
What is clinical trial NCT04055467 about?
NCT04055467 is a clinical study titled "Brain Imaging in Tobacco Smokers During a Quit Attempt". The proposed study will help fill gaps in existing research by determining if nicotine-dependent cigarette smokers show changes in α7 nicotinic acetylcholine receptor (nAChR) availability when compared to matched historical controls using positron emission tomography (PET) imaging and the radioactiv...
What is the current status of trial NCT04055467?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 15 participants. The study started on 2019-12-16. Estimated completion is 2022-11-30.
What conditions does trial NCT04055467 study?
This clinical trial studies the following conditions: Tobacco Use Disorder, Tobacco Smoking.
What interventions are being tested in trial NCT04055467?
The interventions under investigation include: Contingency Management (BEHAVIORAL), [F18]-ASEM (3-(1,4-diazabicyclo[3.2.2]nonan-4-yl)-6-[18F]fluorodibenzo[b,d]thiophene 5,5-dioxide) (DRUG).
Who is sponsoring clinical trial NCT04055467?
This trial is sponsored by Johns Hopkins University, which has 1,448 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT04055467 being conducted?
This trial has 1 study location across Maryland. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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