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Effects of Nicotine Salt Aerosol on Cigarette Smokers

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ClinicalTrials.gov Identifier: NCT03974152
Recruitment Status : Recruiting
First Posted : June 4, 2019
Last Update Posted : August 1, 2019
Sponsor:
Information provided by (Responsible Party):
Paul T. Harrell, Eastern Virginia Medical School

Brief Summary:
This grant compares the effects of cigarette smoking, protonated nicotine ("salt") aerosol, and unprotonated nicotine aerosol on nicotine delivery, nicotine craving, and other outcomes in cigarette smokers.

Condition or disease Intervention/treatment Phase
Electronic Cigarette Use Other: Subox Mini C with Avail 18 mg nicotine salt (protonated) Other: Subox Mini C with Avail 18 mg nicotine (unprotonated) Other: Own brand cigarette Not Applicable

Detailed Description:
The purpose of this study is to determine differences in nicotine delivery, user behavior, subjective effects, and physiological effects, when cigarette smokers use a nicotine "salt" (protonated) aerosol, relative to an unprotonated aerosol or their own brand of cigarettes.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 15 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)
Primary Purpose: Basic Science
Official Title: Effects of Nicotine Salt Aerosol on Cigarette Smokers
Actual Study Start Date : June 10, 2019
Estimated Primary Completion Date : August 31, 2020
Estimated Study Completion Date : August 31, 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Sodium

Arm Intervention/treatment
Active Comparator: Own brand cigarette
Participants will be instructed to take one puff of the tobacco product (cigarette or ENDS) every 30 seconds for 5 minutes followed by a 2nd blood draw. Next, participants will be given 90 minutes to use ad lib, i.e., as much as desired.
Other: Own brand cigarette
Participants will be instructed to take one puff of a cigarette matching their typical brand every 30 seconds for 5 minutes followed by a 2nd blood draw. Next, participants will be given 90 minutes to use the product ad lib, i.e., as much as desired.

Experimental: ENDS: Subox Mini C with 18 mg nicotine salt (protonated)
Participants will be instructed to take one puff of the tobacco product (cigarette or ENDS) every 30 seconds for 5 minutes followed by a 2nd blood draw. Next, participants will be given 90 minutes to use ad lib, i.e., as much as desired.
Other: Subox Mini C with Avail 18 mg nicotine salt (protonated)
Participants will be instructed to take one puff of the Subox Mini C with Avail 18 mg nicotine salt (protonated) liquid every 30 seconds for 5 minutes followed by a 2nd blood draw. Next, participants will be given 90 minutes to use the product ad lib, i.e., as much as desired.

Experimental: ENDS: Subox Mini C with 18 mg nicotine regular (unprotonated)
Participants will be instructed to take one puff of the tobacco product (cigarette or ENDS) every 30 seconds for 5 minutes followed by a 2nd blood draw. Next, participants will be given 90 minutes to use ad lib, i.e., as much as desired.
Other: Subox Mini C with Avail 18 mg nicotine (unprotonated)
Participants will be instructed to take one puff of the Subox Mini C with Avail 18 mg nicotine (unprotonated) liquid every 30 seconds for 5 minutes followed by a 2nd blood draw. Next, participants will be given 90 minutes to use the product ad lib, i.e., as much as desired.




Primary Outcome Measures :
  1. Plasma Nicotine [ Time Frame: Blood will be taken 4 times in each session: baseline, 5 minutes after the start of a 10-puff product use, and then before and after an approximately 1-hour ad lib use period. ]
    Change in plasma nicotine level



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Ages Eligible for Study:   21 Years to 55 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

Participants must be:

  • healthy (determined by self-report)
  • between 21-55 years old
  • wiling to provide informed consent
  • able to attend lab and abstain from tobacco/nicotine as required and agree to use designated products according to study protocol
  • cigarette smokers

Exclusion Criteria:

• Women if breast-feeding or test positive for pregnancy (by urinalysis) at screening

Some study details about eligibility criteria are purposely omitted at this time to preserve scientific integrity. Full details will be posted at the conclusion of the study.


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): NCT03974152


Contacts
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Contact: Study Coordinator 757-446-5920 ecigopinions@gmail.com
Contact: Karen F Nanez 757-446-6007 NanezKF@evms.edu

Locations
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United States, Virginia
Eastern Virginia Medical School Recruiting
Norfolk, Virginia, United States, 23510
Contact: Paul T Harrell    757-446-5920    vapelab@evms.edu   
Contact: Karen F Nanez    7574466007    NanezKF@evms.edu   
Sponsors and Collaborators
Eastern Virginia Medical School
Investigators
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Principal Investigator: Paul T Harrell, Ph.D. Eastern Virginia Medical School

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Responsible Party: Paul T. Harrell, Assistant Professor, Eastern Virginia Medical School
ClinicalTrials.gov Identifier: NCT03974152     History of Changes
Other Study ID Numbers: 19-01-FB-0009
First Posted: June 4, 2019    Key Record Dates
Last Update Posted: August 1, 2019
Last Verified: July 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

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