Brain Imaging in Tobacco Smokers During a Quit Attempt

• Status: Recruiting
• Trial end date: 2022-12-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 1
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: Johns Hopkins University
• Collaborator: National Institute on Drug Abuse (NIDA)
• Treatments: Acetylcholine

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.