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Clinical trial

Brain Imaging of Nicotinic Acetylcholine Receptors in Tobacco Users and Nonusers

ID
Name
IRB00173536
Description
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.
Trial arms
Trial start
2019-12-16
Estimated PCD
2022-10-30
Trial end
2022-11-30
Status
Completed
Phase
Early phase I
Treatment
[F18]-ASEM (3-(1,4-diazabicyclo[3.2.2]nonan-4-yl)-6-[18F]fluorodibenzo[b,d]thiophene 5,5-dioxide)
Brain imaging of alpha-7 nicotinic acetylcholine receptors
Arms:
[F18]-ASEM + Contingency Management
Other names:
[F18]-ASEM
Contingency Management
Incentive payments contingent upon provision of samples that meet criterion levels of exhaled carbon oxide and urinary cotinine at study visits
Arms:
[F18]-ASEM + Contingency Management
Other names:
Incentive payments
Size
15
Primary endpoint
Distribution volume (VT) as determined by [18F]-ASEM PET scan
1 day
Total withdrawal score on the Minnesota Nicotine Withdrawal Scale (MNWS)
2 weeks
Craving/Urge to smoke as determined via the Questionnaire of Subjective Urges (QSU)
2 weeks
Eligibility criteria
Inclusion Criteria: * 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. Exclusion Criteria: * 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.
Protocol
{'studyType': 'INTERVENTIONAL', 'phases': ['PHASE1'], 'designInfo': {'allocation': 'NA', 'interventionModel': 'SINGLE_GROUP', 'primaryPurpose': 'BASIC_SCIENCE', 'maskingInfo': {'masking': 'NONE'}}, 'enrollmentInfo': {'count': 15, 'type': 'ACTUAL'}}
Updated at
2023-05-01

1 organization

1 product

2 indications

Organization
Johns Hopkins University
Product
[F18]-ASEM
Indication
Tobacco Use Disorder
Indication
Smoking