Concurrent PET D2/D3 Receptor Imaging and fMRI Smoking Cue Reactivity in Smokers
This study is not yet open for participant recruitment.
Verified February 2013 by Mclean Hospital
Sponsor:
Mclean Hospital
Collaborator:
Information provided by (Responsible Party):
Marc J. Kaufman, Mclean Hospital
ClinicalTrials.gov Identifier:
NCT01784016
First received: January 30, 2013
Last updated: February 1, 2013
Last verified: February 2013
- Full Text View
- Tabular View
- No Study Results Posted
- Disclaimer
- How to Read a Study Record
Purpose
This trial aims to determine whether dopamine D3 receptors are elevated in smokers versus nonsmokers and whether correlations exist between D3 receptor binding potential (BP) and functional MRI (fMRI) reactivity to smoking cues, which has been associated with smoking relapse vulnerability.
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.
| Condition | Intervention | Phase |
|---|---|---|
|
Nicotine Dependence Smoking Cue Reactivity Relapse to Smoking |
Radiation: [11C]-PHNO |
Phase 1 |
| Study Type: | Interventional |
| Study Design: | Allocation: Non-Randomized Endpoint Classification: Pharmacokinetics/Dynamics Study Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Basic Science |
| Official Title: | Concurrent PET D2/D3 Receptor Imaging and fMRI Smoking Cue Reactivity in Smokers |
Resource links provided by NLM:
Further study details as provided by Mclean Hospital:
Primary Outcome Measures:
- Dopamine D3 Receptor Binding Potential Difference Between Smokers and Nonsmokers [ Time Frame: March 2014 ] [ Designated as safety issue: No ]We will determine whether dopamine D3 receptor binding potential, a dimensionless number which represents the relative concentration of dopamine D3 receptors available for binding, is elevated in smokers versus nonsmoking controls.
Secondary Outcome Measures:
- Smoking Cue fMRI Reactivity Association with Dopamine D3 Receptor Binding Potential [ Time Frame: March 2014 ] [ Designated as safety issue: No ]In smokers, we will determine whether an association exists between smoking cue fMRI reactivity intensity (beta weight) and dopamine D3 receptor binding potential, a relationship between receptor (D3) density and dopamine occupancy.
| Estimated Enrollment: | 45 |
| Study Start Date: | May 2013 |
| Estimated Study Completion Date: | March 2014 |
| Estimated Primary Completion Date: | March 2014 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: 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.
|
Radiation: [11C]-PHNO
[11C]-PHNO will be administered once intravenously to conduct Positron Emission Tomography (PET) measurements of dopamine D2/D3 binding potential.
Other Name: 11C-(+)-4-propyl-3,4,4a,5,6,10b-hexahydro-2H-naphtho[1,2-b][1,4]oxazin-9-ol
|
|
Experimental: 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.
|
Radiation: [11C]-PHNO
[11C]-PHNO will be administered once intravenously to conduct Positron Emission Tomography (PET) measurements of dopamine D2/D3 binding potential.
Other Name: 11C-(+)-4-propyl-3,4,4a,5,6,10b-hexahydro-2H-naphtho[1,2-b][1,4]oxazin-9-ol
|
Eligibility| Ages Eligible for Study: | 18 Years to 50 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | Yes |
Criteria
Inclusion Criteria:
- competent to provide written informed consent
- 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:
- pregnant or able to become pregnant and not willing to undergo blood pregnancy test
- 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
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01784016
Contacts
| Contact: Marc J Kaufman, Ph.D. | 617-855-3469 | kaufman@mclean.harvard.edu |
Locations
| United States, Massachusetts | |
| McLean Hospital | Not yet recruiting |
| Belmont, Massachusetts, United States, 02478 | |
| Principal Investigator: Marc J. Kaufman, Ph.D. | |
| Sub-Investigator: Amy C. Janes, Ph.D. | |
| Sub-Investigator: Blaise deB. Frederick, Ph.D. | |
| Massachusetts General Hospital | Not yet recruiting |
| Boston, Massachusetts, United States, 02114 | |
| Principal Investigator: A. Eden Evins, M.D., M.P.H. | |
| Massachusetts General Hospital, Athinoula A. Martinos Center for Biomedical Imaging | Not yet recruiting |
| Charlestown, Massachusetts, United States, 02129 | |
| Sub-Investigator: Jacob Hooker, Ph.D. | |
| Sub-Investigator: Ciprian Catana, M.D., Ph.D. | |
Sponsors and Collaborators
Mclean Hospital
Investigators
| Principal Investigator: | Marc J. Kaufman, Ph.D. | Mclean Hospital |
More Information
Publications:
| Responsible Party: | Marc J. Kaufman, Director, Translational Imaging Laboratory, McLean Hospital, Mclean Hospital |
| ClinicalTrials.gov Identifier: | NCT01784016 History of Changes |
| Other Study ID Numbers: | SmokingPETD2-3fMRI, R21DA031925-01A1 |
| Study First Received: | January 30, 2013 |
| Last Updated: | February 1, 2013 |
| Health Authority: | United States: Food and Drug Administration United States: Partners Human Research Committee United States: McLean Hospital Institutional Review Board |
Additional relevant MeSH terms:
|
Tobacco Use Disorder Smoking Substance-Related Disorders Mental Disorders Habits |
ClinicalTrials.gov processed this record on May 23, 2013