Trial Outcomes & Findings for Brain Nicotine Receptor Density in Veteran Smokers (NCT NCT01721473)
NCT ID: NCT01721473
Last Updated: 2019-10-07
Results Overview
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.
COMPLETED
184 participants
Primary outcome measures will be determined over approximately 3 weeks
2019-10-07
Participant Flow
Participant milestones
| Measure |
Non-smokers
People who did not smoke or use heavy caffeine or marijuana
|
Menthol Smokers
People who smoke menthol cigarettes.
|
Non-menthol Smokers
People who smoke non-menthol cigarettes
|
Smokers Without Comorbidities
People who smoke without heavy caffeine or marijuana use.
|
Smokers With Caffeine
People who smoke and have heavy caffeine use.
|
Smokers With Marijuana
People who smoke and heavily use marijuana.
|
|---|---|---|---|---|---|---|
|
Overall Study
STARTED
|
47
|
22
|
41
|
34
|
22
|
18
|
|
Overall Study
COMPLETED
|
47
|
22
|
41
|
34
|
22
|
18
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
0
|
0
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Brain Nicotine Receptor Density in Veteran Smokers
Baseline characteristics by cohort
| Measure |
Non-smokers
n=47 Participants
People who did not smoke.
|
Smokers Methol
n=22 Participants
People who smoke menthol cigarettes.
|
Smokers Non Menthol
n=41 Participants
People who smoke non menthol cigarettes.
|
Smokers Without Comorbidities
n=34 Participants
People who smoke but do not have heavy caffeine or marijuana use.
|
Smokers With Caffeine
n=22 Participants
People who smoke and have heavy caffeine use.
|
Smokers With Marijuana
n=18 Participants
People who smoke who have heavy marijuana use
|
Total
n=184 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|---|---|
|
Age, Continuous
|
40.5 years
STANDARD_DEVIATION 13.4 • n=5 Participants
|
43.1 years
STANDARD_DEVIATION 12.9 • n=7 Participants
|
36.4 years
STANDARD_DEVIATION 14.2 • n=5 Participants
|
39.1 years
STANDARD_DEVIATION 13.1 • n=4 Participants
|
46.0 years
STANDARD_DEVIATION 12.9 • n=21 Participants
|
42.3 years
STANDARD_DEVIATION 12.6 • n=8 Participants
|
44 years
STANDARD_DEVIATION 13 • n=8 Participants
|
|
Sex: Female, Male
Female
|
0 Participants
n=5 Participants
|
7 Participants
n=7 Participants
|
14 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=8 Participants
|
21 Participants
n=8 Participants
|
|
Sex: Female, Male
Male
|
47 Participants
n=5 Participants
|
15 Participants
n=7 Participants
|
27 Participants
n=5 Participants
|
34 Participants
n=4 Participants
|
22 Participants
n=21 Participants
|
18 Participants
n=8 Participants
|
163 Participants
n=8 Participants
|
PRIMARY outcome
Timeframe: Primary outcome measures will be determined over approximately 3 weeksPopulation: Non-smokers and smokers (with the set of different conditions: menthol, non-menthol, w/ caffeine, w/ marijuana, w/o caffeine+marijuana) who underwent PET scanning to measure the total volume of distribution Vt in the prefrontal cortex.
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.
Outcome measures
| Measure |
Smoker vs. Non Smoker
n=184 Participants
menthol smoker vs. non-menthol smoker vs. non smoker (w/o caffeine and marijuana) vs. smoker (w/o caffeine and marijuana) vs. smoker w/ caffeine use vs. smoker w/ marijuana use
|
|---|---|
|
PET Scan, Rating Scales
Non-smokers
|
7.1 Vt/fp or mL/cm3
Standard Deviation 1.3
|
|
PET Scan, Rating Scales
Smokers menthol
|
8.6 Vt/fp or mL/cm3
Standard Deviation 1.6
|
|
PET Scan, Rating Scales
Smokers non-menthol
|
7.9 Vt/fp or mL/cm3
Standard Deviation 1.2
|
|
PET Scan, Rating Scales
Smokers w/o caff+marij
|
8.0 Vt/fp or mL/cm3
Standard Deviation 1.2
|
|
PET Scan, Rating Scales
Smokers w/ caff
|
11.9 Vt/fp or mL/cm3
Standard Deviation 5.7
|
|
PET Scan, Rating Scales
Smokers w/ marij
|
10.8 Vt/fp or mL/cm3
Standard Deviation 2.9
|
Adverse Events
Non-smokers
Smokers Methol
Smokers Non Menthol
Smokers Without Comorbidities
Smokers With Caffeine
Smokers With Marijuana
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place