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Feasibility of PET/CT to Detect the Oral/Pulmonary Distribution of Nicotine Following E-cigarette Use

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03491059
Recruitment Status : Recruiting
First Posted : April 9, 2018
Last Update Posted : November 27, 2019
Sponsor:
Information provided by (Responsible Party):
Michael V. Knopp MD, PhD, Ohio State University

Brief Summary:
The investigators aim to (1) establish a methodology for the evaluation of the biodistribution of radio-labeled nicotine following e-cigarette use, (2) determine the oral/pulmonary distribution of nicotine following e-cigarette use, and (3) determine the lowest required dose using the new digital PET/CT technology to provide detailed or accurate oral/pulmonary distribution data following e-cigarette use. Potential participants will be identified using advertisements such as brochures and online social media postings. After participants are identified, their eligibility will be determined using survey tools. All eligible participants will first have a screening visit at the WCIBMI for study participation. During this initial visit, subjects will be informed about the study in detail, and the relevant consent form will be reviewed and signed. If the participant agrees to participate, they will go through a full dress rehearsal. Up to 10 volunteers will only participate in the dress rehearsal. All other volunteers (30) will have a dress rehearsal without radiation exposure on day 1, and then on a second day, they will participate in the full imaging study using 11C-nicotine. During the imaging study, S-nicotine will be labeled with 11C and placed in the cartridge of an e-cigarette. There will be two dose groups: (A) 3 mCi dosage or (B) 9 mCi doses. The investigators intend to use dose level A; however, if it does not lead to the expected results, an alternate dose level as an option is needed, which is the 9 mCi (B) dose level. Subjects will take a maximum of 10 puffs (1 puff per 30 seconds) from the e-cigarette while positioned in the PET/CT system. Dynamic PET/CT imaging will be performed for a maximum of 60 minutes following inhalation. The subject will be placed in the PET camera in order to generate axial images of the following regions: head/neck (e.g., brain, oral cavity, and throat) and thorax (e.g., trachea, lungs). From the PET/CT images, quantitative radioactivity deposition will be determined, and the biodistribution and uptake/clearance will be evaluated. PET data will be acquired in listmode and subsequently used for simulation to determine the potentially lowest dose feasible using the next generation digital PET/CT technology.

Condition or disease Intervention/treatment Phase
E-cigarette Use Drug: C-11 labeled nicotine Radiation: PET/CT imaging Phase 4

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 40 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Basic Science
Official Title: Feasibility of PET/CT to Detect the Oral/Pulmonary Distribution of Nicotine Following E-cigarette Use
Actual Study Start Date : February 16, 2018
Estimated Primary Completion Date : December 31, 2020
Estimated Study Completion Date : February 16, 2021

Resource links provided by the National Library of Medicine

MedlinePlus related topics: E-Cigarettes

Arm Intervention/treatment
Experimental: Full Study - Radiation Drug: C-11 labeled nicotine
Participants will vape with e-cigarettes radio-labeled with C-11 nicotine.

Radiation: PET/CT imaging
After vaping with radio-labeled e-cigarettes, participants will be PET/CT imaged.

No Intervention: Dress Rehearsal Only - No Radiation



Primary Outcome Measures :
  1. Nicotine biodistribution [ Time Frame: Up to 5 - 10 minutes ]
    We will measure the intensity of C11 labeled nicotine uptake, measured as SUV in different target and organ systems

  2. Nicotine uptake [ Time Frame: Up to 5 - 10 minutes ]
    We will measure the intensity of C11 labeled nicotine uptake, measured as SUV in the oral cavity, lungs, blood stream and brain

  3. Nicotine clearance [ Time Frame: Up to 5 - 60 minutes ]
    We will use the intensity of C11 labeled nicotine uptake, measured as SUV in the different target and organ systems in the PET imaging field of view and assess the change of uptake over time as a measure of its elimination



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • males and females greater than or equal to 18 years of age
  • current regular user of e-cigarettes (use at least once daily for the past 30 days) with nicotine strength > 6mg/ml
  • health medical history
  • abstinent from any tobacco/nicotine use for 4 hours prior to imaging

Exclusion Criteria:

  • not a regular user of e-cigarettes
  • pregnant or lactating (only excluded from imaging study)
  • prisoner
  • incapable of giving informed consent
  • unable to lie flat on the scanner for extended periods of time
  • unstable medical condition like heart disease, uncontrolled hypertension, thyroid disease, diabetes, renal or liver impairment, or glaucoma
  • prostatic hypertrophy, stroke, or ulcer in past year
  • psychiatric conditions such as schizophrenia, adult ADHD, or bipolar disorder
  • current or regular use of psychiatric medications such as tranquilizers, antipsychotics, and/or antidepressants
  • use of medications that are inducers of CYP2A6 (a nicotine metabolizing enzyme) such as rifampicin, dexamethasone, phenobarbital, and other anti-convulsant drugs
  • unable to communicate in English
  • current use of smokeless tobacco, tobacco cigarettes (5 and fewer a day)
  • occasional use of pipes is permitted if subject abstains for the week prior to the study
  • older than 80 years

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): NCT03491059


Contacts
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Contact: Melanie Hughes 614-293-9998 office@wcibmi.org
Contact: Michael V Knopp, MD, PhD 614-293-9998 knopp.16@osu.edu

Locations
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United States, Ohio
The Ohio State University Wexner Medical Center Recruiting
Columbus, Ohio, United States, 43221
Contact: Michael V Knopp, MD, PhD    614-293-9998    knopp.16@osu.edu   
Sub-Investigator: Katherine M Binzel, PhD         
Sub-Investigator: Chadwick L Wright, MD, PhD         
Sub-Investigator: Krishan Kumar, PhD         
Sub-Investigator: Karen C Briley, PhD         
Sub-Investigator: Jun Zhang, PhD         
Sponsors and Collaborators
Ohio State University
Investigators
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Principal Investigator: Michael V Knopp, MD, PhD Ohio State University
  Study Documents (Full-Text)

Documents provided by Michael V. Knopp MD, PhD, Ohio State University:
Study Protocol  [PDF] December 20, 2017


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Responsible Party: Michael V. Knopp MD, PhD, Professor, Ohio State University
ClinicalTrials.gov Identifier: NCT03491059    
Other Study ID Numbers: SP0232/2017H0463
First Posted: April 9, 2018    Key Record Dates
Last Update Posted: November 27, 2019
Last Verified: November 2019

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: Yes
Additional relevant MeSH terms:
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Nicotine
Ganglionic Stimulants
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Nicotinic Agonists
Cholinergic Agonists
Cholinergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action