Trial Outcomes & Findings for Test-retest Reproducibility of [11C]PHNO PET Using the Constant Infusion Paradigm (NCT NCT01699607)

Last Updated: 2020-03-06

Results Overview

PET images will be obtained in subjects at baseline and after amphetamine administration. Dopamine release will be measured as a percent change in binding potential. Increased dopamine release will result in decreased radiotracer binding because dopamine will displace the radiotracer.

Recruitment status

COMPLETED

Study phase

Target enrollment

10 participants

Primary outcome timeframe

first 90 minute scan at baseline, second 90 minute scan start 150 minutes post amphetamine administration

Results posted on

2020-03-06

Participant Flow

Participant milestones

Participant milestones
Measure	Cigarette Smokers Cigarette smokers are subjects who smoke 10 or more cigarettes per day for the past year. All subjects will receive amphetamine at 0.5 kg/mg to induce elevated dopamine levels in the brain. This dosage of amphetamine is given by mouth about 150 minutes prior to the second PET scan.	Nonsmoking Subjects Nonsmokers are subjects who have smoked less than 40 cigarettes in their lifetime, and none within the last year. All subjects will receive amphetamine at 0.5 kg/mg to induce elevated dopamine levels in the brain. This dosage of amphetamine is given by mouth about 150 minutes prior to the second PET scan.
Overall Study STARTED	6	4
Overall Study COMPLETED	6	4
Overall Study NOT COMPLETED	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Test-retest Reproducibility of [11C]PHNO PET Using the Constant Infusion Paradigm

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Cigarette Smokers n=6 Participants Cigarette smokers are subjects who smoke 10 or more cigarettes per day in the past year.	Nonsmoker Subjects n=4 Participants Nonsmokers are subjects who smoked 40 cigarettes or less in their lifetime, and none within the past year.	Total n=10 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	6 Participants n=5 Participants	4 Participants n=7 Participants	10 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	0 Participants n=5 Participants	1 Participants n=7 Participants	1 Participants n=5 Participants
Sex: Female, Male Male	6 Participants n=5 Participants	3 Participants n=7 Participants	9 Participants n=5 Participants
Race/Ethnicity, Customized Hispanic	1 participants n=5 Participants	1 participants n=7 Participants	2 participants n=5 Participants
Race/Ethnicity, Customized White, not of Hispanic origin	4 participants n=5 Participants	2 participants n=7 Participants	6 participants n=5 Participants
Race/Ethnicity, Customized African American	1 participants n=5 Participants	1 participants n=7 Participants	2 participants n=5 Participants
Region of Enrollment United States	6 participants n=5 Participants	4 participants n=7 Participants	10 participants n=5 Participants

PRIMARY outcome

Timeframe: first 90 minute scan at baseline, second 90 minute scan start 150 minutes post amphetamine administration

Outcome measures

Outcome measures
Measure	Smoking Subjects n=6 Participants Cigarette smokers. These are subjects who smoke at least 10 cigarettes per day for the last year. All subjects will receive amphetamine to induce elevated dopamine levels in the brain at a dose of 0.5mg/kg. They will all receive the amphetamine prior to the second PET scan.	Nonsmoking Subjects n=4 Participants Nonsmokers. These are subjects who smoked less than 40 cigarettes in their lifetime and none in the last year. All subjects will receive amphetamine to induce elevated dopamine levels in the brain at a dose of 0.5mg/kg. They will all receive the amphetamine prior to the second PET scan
Change in Dopamine Levels at Baseline and After Amphetamine Administration as Measured by Percent Change in PET Tracer Binding Potential.	-21 percent change in binding potential Standard Deviation 12.0	-29 percent change in binding potential Standard Deviation 6.3

Adverse Events

Amphetamine

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

Dr. Kelly Cosgrove, Ph.D.

Yale

Phone: 203-737-6969

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place