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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Kelly Cosgrove, Yale University
ClinicalTrials.gov Identifier:
NCT01699607
First received: October 1, 2012
Last updated: April 6, 2016
Last verified: April 2016
Results First Received: July 14, 2015  
Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment;   Masking: Open Label
Conditions: Nicotine Dependence,
Healthy
Intervention: Drug: Amphetamine

  Participant Flow
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Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
No text entered.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
No text entered.

Reporting Groups
  Description
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.

Participant Flow:   Overall Study
    Cigarette Smokers   Nonsmoking Subjects
STARTED   6   4 
COMPLETED   6   4 
NOT COMPLETED   0   0 



  Baseline Characteristics
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Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
No text entered.

Reporting Groups
  Description
Cigarette Smokers Cigarette smokers are subjects who smoke 10 or more cigarettes per day in the past year.
Nonsmoker Subjects Nonsmokers are subjects who smoked 40 cigarettes or less in their lifetime, and none within the past year.
Total Total of all reporting groups

Baseline Measures
   Cigarette Smokers   Nonsmoker Subjects   Total 
Overall Participants Analyzed 
[Units: Participants]
 6   4   10 
Age 
[Units: Participants]
     
<=18 years   0   0   0 
Between 18 and 65 years   6   4   10 
>=65 years   0   0   0 
Gender 
[Units: Participants]
     
Female   0   1   1 
Male   6   3   9 
Race/Ethnicity, Customized 
[Units: Participants]
     
Hispanic   1   1   2 
White, not of Hispanic origin   4   2   6 
African American   1   1   2 
Region of Enrollment 
[Units: Participants]
     
United States   6   4   10 


  Outcome Measures

1.  Primary:   Change in Dopamine Levels at Baseline and After Amphetamine Administration as Measured by Percent Change in PET Tracer Binding Potential.   [ Time Frame: first 90 minute scan at baseline, second 90 minute scan start 150 minutes post amphetamine administration ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
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Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
Preliminary data. Small subject number.


  More Information
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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:  
Name/Title: Dr. Kelly Cosgrove, Ph.D.
Organization: Yale
phone: 203-737-6969
e-mail: kelly.cosgrove@yale.edu



Responsible Party: Kelly Cosgrove, Yale University
ClinicalTrials.gov Identifier: NCT01699607     History of Changes
Other Study ID Numbers: 0910005822
Study First Received: October 1, 2012
Results First Received: July 14, 2015
Last Updated: April 6, 2016
Health Authority: United States: Institutional Review Board