Brain Imaging in Tobacco Smokers During a Quit Attempt
Completed · Phase 1
Conditions studied: Tobacco Use Disorder, Tobacco Smoking
In brief
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.
Key facts
- Study ID
- NCT04055467
- Run by
- Johns Hopkins University
- People needed
- 15
- Starts
- 2019-12-16
- Expected to finish
- 2022-11-30
- Last updated by the study team
- 2024-08-06
Who can join
Age: 21 and older, up to 50. Sex: any. Healthy volunteers: accepted.
You may qualify if…
- Subjects must be healthy volunteers
- Regular tobacco smokers for a period of 2 or more years
- Positive breath carbon monoxide (CO)
- Cotinine positive urine test
- Meet DSM-V criteria for tobacco use disorder.
You may not qualify if…
- Meets DSM-5 criteria for alcohol use disorder or substance use disorder (excluding tobacco use disorder)
- Meets DSM-5 Psychiatric Disorder; in or in need of treatment
- History of seizures, seizure disorder or closed head trauma
- HIV positive
- Weight > 350 lbs
- < 5th grade reading level
- Recent use of smoking cessation products
- If female: pregnant, lactating, planning pregnancy; positive urine pregnancy screen
- Any condition which would preclude MRI
- Radiation exposure in the last year that when combined with the study protocol would exceed the annual limits.
Where it is running
- Elise Weerts — Baltimore, Maryland, United States
Full record on ClinicalTrials.gov
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