Phase 1
N=15
Brain Imaging in Tobacco Smokers During a Quit Attempt
Tobacco Use Disorder · Tobacco Smoking
Bottom Line
View on ClinicalTrials.gov: NCT04055467 ↗Enrolled (actual)
15
Serious AEs
0.0%
Results posted
Aug 2024
Primary outcome: Primary: Distribution Volume (VT) as Determined by [18F]-ASEM PET Scan — 22.640; 21.588; 22.226; 17.431 mL/cm^3
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 1
- Interventions
- [F18]-ASEM (3-(1,4-diazabicyclo[3.2.2]nonan-4-yl)-6-[18F]fluorodibenzo[b,d]thiophene 5,5-dioxide) (Drug); Contingency Management (Behavioral)
- Age
- Adult · 21+ yrs
- Sex
- All
- Sponsor
- Johns Hopkins University
- Primary completion
- Oct 2022
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Distribution Volume (VT) as Determined by [18F]-ASEM PET Scan |
22.640; 21.588; 22.226; 17.431; 20.454 | — |
| PRIMARY Total Withdrawal Score on the Minnesota Nicotine Withdrawal Scale (MNWS) on Day of PET Scan |
10.667 | — |
| PRIMARY Craving/Urge to Smoke as Determined Via the Questionnaire of Subjective Urges (QSU) on Day of PET Scan |
42.667; 22.7 | — |
| SECONDARY Cigarettes Smoked Per Day |
17.00 | — |
| SECONDARY Number of Days of Smoking Abstinence on Day of PET Scan |
1 | — |
| SECONDARY Negative Mood as Determined by the Positive and Negative Affect Scale (PANAS) |
4.7; 5.7 | — |
| SECONDARY Attention as Assessed by Connors Continuous Performance Task |
43.3; 50 | — |
| SECONDARY Performance on the Paced Serial Addition Task (PASAT) |
65.7; 71.7 | — |
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.
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.
Data sourced from ClinicalTrials.gov (NCT04055467). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.