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.

Recruitment status

COMPLETED

Target enrollment

184 participants

Primary outcome timeframe

Primary outcome measures will be determined over approximately 3 weeks

Results posted on

2019-10-07

Participant Flow

Participant milestones

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

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 weeks

Population: 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

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

Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths

Smokers Methol

Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths

Smokers Non Menthol

Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths

Smokers Without Comorbidities

Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths

Smokers With Caffeine

Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths

Smokers With Marijuana

Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Arthur Brody

VA San Diego Healthcare System

Phone: 8585528585

Results disclosure agreements

  • Principal investigator is a sponsor employee
  • Publication restrictions are in place