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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: Completed Phase 1 study of Tobacco Use Disorder and Tobacco Smoking, sponsored by Johns Hopkins University.
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. According to ClinicalTrials.gov, the official US trial registry.
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.
Primary Outcome
Distribution volume (VT) in volumes of interest (VOI) in tobacco smokers. VOI are cingulate, hippocampus, frontal cortex, amygdala, and ventral striatum. VOI are defined via each individual subject's Magnetic Resonance Imaging for anatomical identification of the VOI for alignment with PET images.
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 |
What the finished NCT04055467 record still lists
NCT04055467 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 15 participants, a relatively small participant target, below the 239-participant average among 70 other Tobacco Use Disorder trials with a reported enrollment target (94% lower).
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 a single indexed study location in 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.
Learn More About Clinical Trials
Similar trials for Tobacco Use Disorder
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT04055467's enrollment target sits among peer trials
15 69th of 70 higher than 2 of 70 other Tobacco Use Disorder trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Tobacco Use Disorder 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.
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