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Imaging Extrastriatal Dopamine Release in Tobacco Smokers and Nonsmokers

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ClinicalTrials.gov Identifier: NCT02348385
Recruitment Status : Completed
First Posted : January 28, 2015
Last Update Posted : December 18, 2018
Sponsor:
Information provided by (Responsible Party):
Yale University

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

Condition or disease Intervention/treatment
Nicotine Dependence Drug: Amphetamine

Detailed Description:

Aim 1:

To determine sex differences in amphetamine-induced dopamine (DA) release in healthy tobacco smokers and nonsmokers.

FLB-457 has been used in several PET centers and has recently been approved for use at the Yale University PET Center. We would like to determine whether there are sex differences in amphetamine induced DA release in healthy tobacco smokers and nonsmokers. Specifically, 40 healthy tobacco smokers and 40 healthy nonsmokers will have an magnetic resonance imaging (MRI) scan followed on another day by two FLB scans (ideally, the two PET scans will be carried out in the same day). Starting at 3 hours before the second PET scan, amphetamine (0.4mg/kg, PO) will be administered.

Aim 2:

To determine sex differences in amphetamine-induced dopamine release in tobacco smokers from Aim 1 after treatment with guanfacine. Guanfacine will be given under a different protocol. We plan to determine whether guanfacine treatment differentially inhibits amphetamine-induced DA release in men and smokers from Aim 1. After their first scan, the same 40 healthy tobacco smokers from Aim 1 will take guanfacine for 3 weeks under and then will have another set of FLB scans (ideally, the two PET scans will be carried out in the same day). Starting at 3 hours before the second PET scan, amphetamine (0.4mg/kg, PO) will be administered, as before. The sets of scans will be separated by at least 21 days, but due to scheduling and technical difficulties the second set may be scheduled up to 6 weeks after the first set.


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Study Type : Observational
Actual Enrollment : 52 participants
Observational Model: Case-Control
Time Perspective: Prospective
Official Title: Imaging Extrastriatal Dopamine Release in Tobacco Smokers and Nonsmokers
Study Start Date : December 2012
Actual Primary Completion Date : December 2017
Actual Study Completion Date : December 2017

Resource links provided by the National Library of Medicine


Group/Cohort Intervention/treatment
Healthy Tobacco Smokers
There is only one arm to the study. All subjects will receive amphetamine
Drug: Amphetamine
Subjects will have 2 PET scans on the same day. Up to 3 hours before the second PET Scan, amphetamine (0.4mg/kg, orally) will be administered.
Other Name: dextroamphetamine

Healthy Nonsmokers
There is only one arm to the study. All subjects will receive amphetamine
Drug: Amphetamine
Subjects will have 2 PET scans on the same day. Up to 3 hours before the second PET Scan, amphetamine (0.4mg/kg, orally) will be administered.
Other Name: dextroamphetamine




Primary Outcome Measures :
  1. Percent change in binding potential of dopamine release during PET scan post amphetamine administration [ Time Frame: After 2 PET Scans (1 day) ]

Biospecimen Retention:   Samples Without DNA
Samples will be obtained for hormones and amphetamine drug levels


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 55 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Probability Sample
Study Population
Healthy Smokers and non smokers
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 < 100 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 Fagerstrom score (FTND)>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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02348385


Locations
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United States, Connecticut
Yale University
New Haven, Connecticut, United States, 06519
Sponsors and Collaborators
Yale University
Investigators
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Principal Investigator: Kelly Cosgrove, PhD Yale University

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Responsible Party: Yale University
ClinicalTrials.gov Identifier: NCT02348385     History of Changes
Other Study ID Numbers: 1106008678
First Posted: January 28, 2015    Key Record Dates
Last Update Posted: December 18, 2018
Last Verified: December 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Keywords provided by Yale University:
amphetamine
cigarette smokers

Additional relevant MeSH terms:
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Tobacco Use Disorder
Substance-Related Disorders
Chemically-Induced Disorders
Mental Disorders
Dopamine
Amphetamine
Dextroamphetamine
Cardiotonic Agents
Sympathomimetics
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Dopamine Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Protective Agents
Central Nervous System Stimulants
Adrenergic Agents
Adrenergic Uptake Inhibitors
Neurotransmitter Uptake Inhibitors
Membrane Transport Modulators
Dopamine Uptake Inhibitors