Concurrent PET D2/D3 Receptor Imaging and fMRI Smoking Cue Reactivity in Smokers
NCT ID: NCT01784016
Last Updated: 2014-05-23
Study Results
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Basic Information
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WITHDRAWN
PHASE1
INTERVENTIONAL
2014-01-31
2014-05-31
Brief Summary
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Neuroimaging measures of D3 BP and smoking cue fMRI reactivity will be collected concurrently in otherwise healthy nicotine-dependent smokers and age-matched nonsmokers using a 3 Tesla MRI scanner configured to conduct fMRI and Positron Emission Tomography (PET).
We will measure D3 receptor BP using radiolabeled \[11C\]-(+)-PHNO, which has a relatively higher affinity for D3 versus D2 receptors.
We hypothesize that D3 BP will be elevated in smokers versus nonsmokers and that in smokers, there will be a positive correlation between smoking cue fMRI reactivity and D3 BP.
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Detailed Description
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Conditions
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Study Design
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NON_RANDOMIZED
PARALLEL
BASIC_SCIENCE
NONE
Study Groups
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Healthy Smokers
Healthy smokers aged 18-50 years reporting average cigarette consumption of 15 or more cigarettes/day for the past year, providing an expired breath carbon monoxide reading exceeding 10 ppm at screening.
[11C]-PHNO
\[11C\]-PHNO will be administered once intravenously to conduct Positron Emission Tomography (PET) measurements of dopamine D2/D3 binding potential.
Healthy Nonsmokers
Healthy nonsmoking controls aged 18-50 reporting consumption of \<100 cigarettes in their lifetime, none in the last 6 months, providing an exhaled breath carbon monoxide reading of \< 9 ppm at screening.
[11C]-PHNO
\[11C\]-PHNO will be administered once intravenously to conduct Positron Emission Tomography (PET) measurements of dopamine D2/D3 binding potential.
Interventions
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[11C]-PHNO
\[11C\]-PHNO will be administered once intravenously to conduct Positron Emission Tomography (PET) measurements of dopamine D2/D3 binding potential.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Smokers: self-report of smoking 15 or more cigarettes/day for the past year, self-report of smoking first cigarette of the day within 30 minutes of awakening, meets DSM-IV criteria for Nicotine Dependence, provides expired breath carbon monoxide reading of \> 10 ppm at enrollment
* Nonsmokers: self-report of consuming \<100 cigarettes in their lifetime, none in the last 6 months, provides expired breath carbon monoxide reading of \< 9 ppm at enrollment
* Women of childbearing potential: negative STAT serum beta-human chorionic gonadotrophin pregnancy test before scanning
Exclusion Criteria
* unstable medical illness with likely hospitalization for treatment within 6 months
* life-threatening arrhythmia, cerebro-vascular or cardiovascular event within 6 months of enrollment; liver function tests elevated over 2.5x normal; CNS tumor or seizure disorder
* users of other tobacco- or nicotine-containing products (gum, patches, e-cigarettes)
* lifetime history of DSM-IV bulimia, organic mental disorder, brain injury or psychotic disorder
* 6 month history of non-nicotine substance use disorder or major depression
* history of multiple adverse drug reactions
* current use of excluded concomitant medications (smoking cessation medications)
* known history of allergic reaction to the PET ligand \[11C\]-PHNO, its components, or any medication
18 Years
50 Years
ALL
Yes
Sponsors
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National Institute on Drug Abuse (NIDA)
NIH
Mclean Hospital
OTHER
Responsible Party
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Marc J. Kaufman
Director, Translational Imaging Laboratory, McLean Hospital
Principal Investigators
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Marc J. Kaufman, Ph.D.
Role: PRINCIPAL_INVESTIGATOR
Mclean Hospital
Locations
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McLean Hospital
Belmont, Massachusetts, United States
Massachusetts General Hospital
Boston, Massachusetts, United States
Massachusetts General Hospital, Athinoula A. Martinos Center for Biomedical Imaging
Charlestown, Massachusetts, United States
Countries
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References
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Janes AC, Pizzagalli DA, Richardt S, deB Frederick B, Chuzi S, Pachas G, Culhane MA, Holmes AJ, Fava M, Evins AE, Kaufman MJ. Brain reactivity to smoking cues prior to smoking cessation predicts ability to maintain tobacco abstinence. Biol Psychiatry. 2010 Apr 15;67(8):722-9. doi: 10.1016/j.biopsych.2009.12.034. Epub 2010 Feb 20.
Le Foll B, Diaz J, Sokoloff P. Increased dopamine D3 receptor expression accompanying behavioral sensitization to nicotine in rats. Synapse. 2003 Mar;47(3):176-83. doi: 10.1002/syn.10170.
Searle G, Beaver JD, Comley RA, Bani M, Tziortzi A, Slifstein M, Mugnaini M, Griffante C, Wilson AA, Merlo-Pich E, Houle S, Gunn R, Rabiner EA, Laruelle M. Imaging dopamine D3 receptors in the human brain with positron emission tomography, [11C]PHNO, and a selective D3 receptor antagonist. Biol Psychiatry. 2010 Aug 15;68(4):392-9. doi: 10.1016/j.biopsych.2010.04.038.
Tziortzi AC, Searle GE, Tzimopoulou S, Salinas C, Beaver JD, Jenkinson M, Laruelle M, Rabiner EA, Gunn RN. Imaging dopamine receptors in humans with [11C]-(+)-PHNO: dissection of D3 signal and anatomy. Neuroimage. 2011 Jan 1;54(1):264-77. doi: 10.1016/j.neuroimage.2010.06.044. Epub 2010 Jun 30.
Wilson AA, McCormick P, Kapur S, Willeit M, Garcia A, Hussey D, Houle S, Seeman P, Ginovart N. Radiosynthesis and evaluation of [11C]-(+)-4-propyl-3,4,4a,5,6,10b-hexahydro-2H-naphtho[1,2-b][1,4]oxazin-9-ol as a potential radiotracer for in vivo imaging of the dopamine D2 high-affinity state with positron emission tomography. J Med Chem. 2005 Jun 16;48(12):4153-60. doi: 10.1021/jm050155n.
Pak AC, Ashby CR Jr, Heidbreder CA, Pilla M, Gilbert J, Xi ZX, Gardner EL. The selective dopamine D3 receptor antagonist SB-277011A reduces nicotine-enhanced brain reward and nicotine-paired environmental cue functions. Int J Neuropsychopharmacol. 2006 Oct;9(5):585-602. doi: 10.1017/S1461145706006560. Epub 2006 Aug 31.
Other Identifiers
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SmokingPETD2-3fMRI
Identifier Type: -
Identifier Source: org_study_id
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