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N/A N=49

Imaging Extrastriatal Dopamine Release in Tobacco Smokers and Nonsmokers

Nicotine Dependence

Enrolled (actual)
49
Serious AEs
0.0%
Results posted
Mar 2020
Primary outcome: Primary: Percent Change in Binding Potential of Dopamine Release During PET Scan Post Amphetamine Administration — 14; 11.2; 1.9; 9.3 percentage change in binding potential

Study Design & Population

Study type
Observational
Phase
N/A
Interventions
Amphetamine (Drug)
Age
Adult · 18+ yrs
Sex
All
Sponsor
Yale University
Primary completion
Dec 2017

Outcome Measures

OutcomeResultp-value
PRIMARY
Percent Change in Binding Potential of Dopamine Release During PET Scan Post Amphetamine Administration
14; 11.2; 1.9; 9.3

Summary

The goal is to examine sex differences in amphetamine-induced dopamine release in tobacco smokers and nonsmokers.

Eligibility Criteria

General 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 DSM-IV Axis 1 diagnosis in 2 preceding years)
  • 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
  • to participate in imaging studies including 2 PET scans and 1 MRI scan
  • nonsmokers (smoked 3, urine cotinine >150 ng/mL and carbon monoxide (CO) >12 ppm at intake)

General 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 at 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.
  • Blood donation within 8 weeks of the start of the study.
  • history of a bleeding disorder or are taking medication to thin their blood
View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT02348385). 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.

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