Trial Outcomes & Findings for Imaging Extrastriatal Dopamine Release in Tobacco Smokers and Nonsmokers (NCT NCT02348385)
NCT ID: NCT02348385
Last Updated: 2023-03-02
Results Overview
Percent change in binding potential of dopamine release during PET scan post amphetamine administration.Binding potential (BP) is the PET neuroimaging outcome measure that is computed as a proxy for availability of dopamine D2/3 receptors in a given region-of-interest.
Recruitment status
COMPLETED
Target enrollment
49 participants
Primary outcome timeframe
After 2 PET Scans (1 day)
Results posted on
2023-03-02
Participant Flow
Participant milestones
| Measure |
Healthy Tobacco Smokers
There is only one arm to the study. All subjects will receive amphetamine
Amphetamine: Subjects will have 2 PET scans on the same day. Up to 3 hours before the second PET Scan, amphetamine (0.4mg/kg, orally) will be administered.
|
Healthy Nonsmokers
There is only one arm to the study. All subjects will receive amphetamine
Amphetamine: Subjects will have 2 PET scans on the same day. Up to 3 hours before the second PET Scan, amphetamine (0.4mg/kg, orally) will be administered.
|
|---|---|---|
|
Overall Study
STARTED
|
24
|
25
|
|
Overall Study
COMPLETED
|
24
|
25
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Imaging Extrastriatal Dopamine Release in Tobacco Smokers and Nonsmokers
Baseline characteristics by cohort
| Measure |
Healthy Tobacco Smokers
n=24 Participants
Healthy Tobacco Smoker Subjects will have 2 PET scans on the same day. Up to 3 hours before the second PET Scan, amphetamine (0.4mg/kg, orally) will be administered.
|
Healthy Nonsmokers
n=25 Participants
Healthy Nonsmoker Subjects will have 2 PET scans on the same day. Up to 3 hours before the second PET Scan, amphetamine (0.4mg/kg, orally) will be administered.
|
Total
n=49 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
24 Participants
n=5 Participants
|
25 Participants
n=7 Participants
|
49 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Sex: Female, Male
Female
|
12 Participants
n=5 Participants
|
12 Participants
n=7 Participants
|
24 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
12 Participants
n=5 Participants
|
13 Participants
n=7 Participants
|
25 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
2 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
5 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
11 Participants
n=5 Participants
|
6 Participants
n=7 Participants
|
17 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
11 Participants
n=5 Participants
|
15 Participants
n=7 Participants
|
26 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
24 participants
n=5 Participants
|
25 participants
n=7 Participants
|
49 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: After 2 PET Scans (1 day)Percent change in binding potential of dopamine release during PET scan post amphetamine administration.Binding potential (BP) is the PET neuroimaging outcome measure that is computed as a proxy for availability of dopamine D2/3 receptors in a given region-of-interest.
Outcome measures
| Measure |
Male Healthy Tobacco Smokers
n=12 Participants
Healthy Tobacco Smoker Subjects will have 2 PET scans on the same day. Up to 3 hours before the second PET Scan, amphetamine (0.4mg/kg, orally) will be administered.
|
Male Healthy Nonsmokers
n=13 Participants
Healthy Nonsmoker Subjects will have 2 PET scans on the same day. Up to 3 hours before the second PET Scan, amphetamine (0.4mg/kg, orally) will be administered.
|
Female Healthy Tobacco Smokers
n=12 Participants
Healthy Tobacco Smoker Subjects will have 2 PET scans on the same day. Up to 3 hours before the second PET Scan, amphetamine (0.4mg/kg, orally) will be administered.
|
Female Healthy Nonsmokers
n=12 Participants
Healthy Tobacco Smoker Subjects will have 2 PET scans on the same day. Up to 3 hours before the second PET Scan, amphetamine (0.4mg/kg, orally) will be administered.
|
|---|---|---|---|---|
|
Percent Change in Binding Potential of Dopamine Release During PET Scan Post Amphetamine Administration
|
14 percentage change in binding potential
Standard Deviation 4.3
|
11.2 percentage change in binding potential
Standard Deviation 2.4
|
1.9 percentage change in binding potential
Standard Deviation 3.0
|
9.3 percentage change in binding potential
Standard Deviation 3.3
|
Adverse Events
Healthy Tobacco Smokers
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Healthy Nonsmokers
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
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place