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

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ClinicalTrials.gov Identifier: NCT01699607
Recruitment Status : Completed
First Posted : October 3, 2012
Results First Posted : September 18, 2015
Last Update Posted : February 9, 2017
Sponsor:
Information provided by (Responsible Party):
Kelly Cosgrove, Yale University

Study Type Interventional
Study Design Intervention Model: Single Group Assignment;   Masking: None (Open Label)
Conditions Nicotine Dependence
Healthy
Intervention Drug: Amphetamine
Enrollment 10
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Cigarette Smokers Nonsmoking Subjects
Hide Arm/Group Description 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. 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.
Period Title: Overall Study
Started 6 4
Completed 6 4
Not Completed 0 0
Arm/Group Title Cigarette Smokers Nonsmoker Subjects Total
Hide Arm/Group Description Cigarette smokers are subjects who smoke 10 or more cigarettes per day in the past year. Nonsmokers are subjects who smoked 40 cigarettes or less in their lifetime, and none within the past year. Total of all reporting groups
Overall Number of Baseline Participants 6 4 10
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 6 participants 4 participants 10 participants
<=18 years
0
   0.0%
0
   0.0%
0
   0.0%
Between 18 and 65 years
6
 100.0%
4
 100.0%
10
 100.0%
>=65 years
0
   0.0%
0
   0.0%
0
   0.0%
Gender  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 6 participants 4 participants 10 participants
Female
0
   0.0%
1
  25.0%
1
  10.0%
Male
6
 100.0%
3
  75.0%
9
  90.0%
Race/Ethnicity, Customized  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 6 participants 4 participants 10 participants
Hispanic 1 1 2
White, not of Hispanic origin 4 2 6
African American 1 1 2
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 6 participants 4 participants 10 participants
6 4 10
1.Primary Outcome
Title Change in Dopamine Levels at Baseline and After Amphetamine Administration as Measured by Percent Change in PET Tracer Binding Potential.
Hide Description 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.
Time Frame first 90 minute scan at baseline, second 90 minute scan start 150 minutes post amphetamine administration
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Smoking Subjects Nonsmoking Subjects
Hide Arm/Group Description:
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.
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
Overall Number of Participants Analyzed 6 4
Mean (Standard Deviation)
Unit of Measure: percent change in binding potential
-21  (12.0) -29  (6.3)
Time Frame 1 year
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Amphetamine
Hide Arm/Group Description

There is only one arm to the study. All subjects will receive amphetamine.

Amphetamine: All subjects will receive amphetamine to induce elevated dopamine levels in the brain.

All-Cause Mortality
Amphetamine
Affected / at Risk (%)
Total   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
Amphetamine
Affected / at Risk (%)
Total   0/10 (0.00%) 
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Amphetamine
Affected / at Risk (%)
Total   0/10 (0.00%) 
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Dr. Kelly Cosgrove, Ph.D.
Organization: Yale
Phone: 203-737-6969
EMail: kelly.cosgrove@yale.edu
Layout table for additonal information
Responsible Party: Kelly Cosgrove, Yale University
ClinicalTrials.gov Identifier: NCT01699607     History of Changes
Other Study ID Numbers: 0910005822
First Submitted: October 1, 2012
First Posted: October 3, 2012
Results First Submitted: July 14, 2015
Results First Posted: September 18, 2015
Last Update Posted: February 9, 2017