N/A Completed N=10 Other

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

Nicotine Dependence · Healthy

Source: ClinicalTrials.gov NCT01699607 ↗

Enrolled (actual)

Serious AEs

0.0%

Results posted

Sep 2015

Primary outcomePrimary: Change in Dopamine Levels at Baseline and After Amphetamine Administration as Measured by Percent Change in PET Tracer Binding Potential. — -21; -29 percent change in binding potential

Summary

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 scan will occur at 10-21 days of smoking abstinence.

Outcome Measures

Outcome	Result	p-value
PRIMARY Change in Dopamine Levels at Baseline and After Amphetamine Administration as Measured by Percent Change in PET Tracer Binding Potential.	-21; -29	—

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 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

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT01699607). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.