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

Conditions

Nicotine Dependence

Trial Phase

Phase I

Trial Purpose and Description

Trial Purpose

A research study designed to examine amphetamine-induced dopamine release using the PET imaging agent [11C]PHNO in tobacco smokers while currently smoking and during acute withdrawal and in nonsmokers. Twenty healthy men and women tobacco smokers and twenty healthy nonsmokers will be recruited. Each subject will participate in 1 MRI and up to 2 [11C]PHNO PET scans. On the study day subjects will participate in two [11C]PHNO scans (ideally, the two PET scans will be carried out in the same day). Three hours before the second PET scan, amphetamine (0.5 mg/kg, PO) will be administered. In smokers, the scanwill occur at 10-21 days of smoking abstinence.


Participation Guidelines

Age:
18 Years - 55 Years
Gender:
Both

Eligibility Criteria

Inclusion Criteria:

  • men and women, aged 18-55 years
  • who are able to read and write
  • who are able to give voluntary written informed consent
  • have no current uncontrolled medical condition such as neurological, cardiovascular, endocrine, renal, liver, or thyroid pathology
  • have no history of a neurological or psychiatric disorder, e.g., no DSMIV Axis 1 diagnosis in 2 preceding years, except nicotine dependence in smokers)
  • drink less than 21 drinks/week for women and less than 35 drinks per week for men
  • have not used marijuana in the past 30 days and have not met criteria for dependence in the past 2 years
  • do not suffer from claustrophobia or any MRI contradictions
  • nonsmokers (smoked < 40 cigarettes in lifetime with urinary cotinine levels 0-30 ng/mL both at intake evaluation and on scan day)
  • smokers (smoked at least 10 cigarettes/day for at least one year with an FTND>3, urine cotinine >150 ng/mL and CO >12 ppm at intake)

Exclusion Criteria:

  • psychosis
  • presence of acute or unstable medical or neurological illness. Subjects will be excluded from the study if they present with any history of serious medical or neurological illness or if they show signs of a major medical or neurological illness on examination or lab testing including history of seizures, head injury, brain tumor, heart, liver or kidney disease, eating disorder, diabetes.
  • regular use of any psychotropic drugs including anxiolytics and antidepressants and other over-the-counter medications and herbal products within the last six months
  • pregnancy/breast feeding (as documented by pregnancy testing at screening or on days of the imaging studies),
  • suicidal ideation or behavior
  • pacemaker or other ferromagnetic material in body.
  • use of medications which affect dopamine transmission within 2 weeks of the PET study
  • participation in other research studies involving ionizing radiation within one year of the PET scans that would cause the subject to exceed the yearly dose limits for normal volunteers
Sponsor:
National Institute on Drug Abuse
Dates:
06/18/2010
Last Updated:
Study HIC#:
0910005822