NCT04055467|CompletedPhase 1ResultsDMCFDA Drug
Brain Imaging in Tobacco Smokers During a Quit Attempt
Brain Imaging of Nicotinic Acetylcholine Receptors in Tobacco Users and Nonusers
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Brain Imaging of Nicotinic Acetylcholine Receptors in Tobacco Users and Nonusers
Sponsor study identifier
Secondary identifiers
interventional
15
1 country
1
Study Start
December 16, 2019
Actual (reported)Primary Completion
October 30, 2022
Actual (reported)Study Completion
November 30, 2022
Actual (reported)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.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
November 30, 2022
Actual (reported)Click on a node to explore related trials.
Some registry-reported names shown below are not yet linked in this graph.
Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
August 12, 2019
Actual (reported)August 13, 2019
Actual (reported)December 16, 2019
Actual (reported)October 30, 2022
Actual (reported)November 30, 2022
Actual (reported)August 6, 2024
Actual (reported)Distribution Volume (VT) as Determined by [18F]-ASEM PET Scan
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.
1 day
Total Withdrawal Score on the Minnesota Nicotine Withdrawal Scale (MNWS) on Day of PET Scan
Self-report form has a 15-item list of symptoms where subjects self-rate symptom severity on a scale of 0-4. Validated symptoms for tobacco withdrawal in smokers will be used for the study to quantify total withdrawal symptoms at baseline (smoking as usual), when compared to symptoms on the day of the PET scan. Scores for each item range from 0-4, with 0 representing no symptoms and 4 representing severe withdrawal symptoms. The score range for validated symptoms is 0-36. Higher scores indicate greater nicotine withdrawal severity. Results reported are scores from day of PET scan.
1 day
Craving/Urge to Smoke as Determined Via the Questionnaire of Subjective Urges (QSU) on Day of PET Scan
The QSU is a 10-item questionnaire to measure craving/urges to smoke. For each item, subjects rate how strongly the subject feel "right now" on a Likert scale ranging from 1 (strongly disagree) to 7 (strongly agree). Items are summed to yield two factor scores, Factor 1 Intention/desire to smoke (minimum score=5, maximum score=35), and Factor 2: Relief of negative affect and Urgent desire to smoke (minimum score=5, maximum score=35). Factor 1 and Factor 2 scores are combined, with a score range of 10-70, higher score indicating maximum cravings/urges to smoke (worse). Results reported reflect QSU scores on day of PET scan vs baseline.
Cigarettes Smoked Per Day
3 months
Number of Days of Smoking Abstinence on Day of PET Scan
1 day
Negative Mood as Determined by the Positive and Negative Affect Scale (PANAS)
Baseline, Day of PET
Attention as Assessed by Connors Continuous Performance Task
Baseline, Day of PET
Performance on the Paced Serial Addition Task (PASAT)
Baseline, Day of PET
PET radiopharmaceutical 3-(1,4-diazabicyclo\[3.2.2\]nonan-4-yl)-6 \[18F\]fluorodibenzo\[b,d\]thiophene 5,5-dioxide with incentive payments.
Brain imaging of alpha-7 nicotinic acetylcholine receptors
Incentive payments contingent upon provision of samples that meet criterion levels of exhaled carbon oxide and urinary cotinine at study visits
Elise Weerts
Baltimore, Maryland, 21224, United States
Elise Weerts, Ph.D.
Johns Hopkins University
15 participants (actual enrollment reported by the registry).
First Submitted
August 12, 2019
First Posted
August 13, 2019
Study Start
December 16, 2019
Actual (reported)To Assess the Bioequivalence of the 4mg Prototype Mini Nicotine Lozenge to the Reference Product (Nicorette) in Healthy Smokers
1 day
Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.
Contact the study team to confirm eligibility.
Primary Completion
October 30, 2022
Actual (reported)Study Completion
November 30, 2022
Actual (reported)Last Updated
August 6, 2024
Results First Posted
August 6, 2024
Record last verified: 2024-07
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Source: ClinicalTrials.gov.
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