Adults 18 to 65, any sex, with Positron Emission Tomography. Patients with the condition only — healthy volunteers not accepted.
Results — posted to ClinicalTrials.gov
Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.
PET Scan, Rating ScalesPrimary· Primary outcome measures will be determined over approximately 3 weeks
Vt/fp values (indicating relative densities of alpha4beta2 nicotinic acetylcholine receptors in different brain regions) in various brain regions - can also be referred to as mL/cm3.
Non-smokers
Group
Value
95% CI
Smoker vs. Non Smoker
7.1
± 1.3
Smokers menthol
Group
Value
95% CI
Smoker vs. Non Smoker
8.6
± 1.6
Smokers non-menthol
Group
Value
95% CI
Smoker vs. Non Smoker
7.9
± 1.2
Smokers w/o caff+marij
Group
Value
95% CI
Smoker vs. Non Smoker
8.0
± 1.2
Smokers w/ caff
Group
Value
95% CI
Smoker vs. Non Smoker
11.9
± 5.7
Smokers w/ marij
Group
Value
95% CI
Smoker vs. Non Smoker
10.8
± 2.9
Sponsor's own description
Cigarette smoking is more prevalent among Veterans (27%) than the general U.S. population (21%). Smoking is common among people who use marijuana or caffeine heavily, and the use of menthol cigarettes is becoming increasingly common, affecting approximately 9% of the Veteran population. Recent research by the group and others indicates that heavy marijuana or caffeine use, or the use of predominantly menthol cigarettes, can alter brain nicotinic acetylcholine receptor (nAChR) densities. For the proposed study, brain imaging with PET scanning will be used to determine nicotine receptor densities in Veteran cigarette smokers with and without heavy marijuana or caffeine use, and in menthol and non-menthol Veteran smokers. Results of the proposed research may have implications for improving treatments for Veterans who smoke cigarettes and who have specific drug use co-morbidities or who use menthol cigarettes.
Publications & conference data
No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.
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Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by VA Office of Research and Development
Last refreshed: 7 October 2019
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT01721473.