Clinical Trials Logo
  1. Home
  2. Electronic Cigarette Use
  3. NCT03974152
  4. Details
NCT03974152 Clinical Trial

Effects of Nicotine Salt Aerosol on Cigarette Smokers

Electronic Cigarette Use Clinical Trial

Official title:
Effects of Nicotine Salt Aerosol on Cigarette Smokers

Clinical Trial Details — Status: Terminated

Administrative data
NCT number NCT03974152
Other study ID # 19-01-FB-0009
Secondary ID U54DA036105FP000
Status Terminated
Phase N/A
First received
Last updated
Start date June 10, 2019
Est. completion date March 5, 2020

Study information
Verified date February 2024
Source Eastern Virginia Medical School
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

This grant compares the effects of cigarette smoking, protonated nicotine ("salt") aerosol through an Electronic Nicotine Delivery System (ENDS), and unprotonated nicotine aerosol through an ENDS on nicotine delivery, nicotine craving, and other outcomes in cigarette smokers.

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.

Recruitment information / eligibility
Status Terminated
Enrollment 11
Est. completion date March 5, 2020
Est. primary completion date March 5, 2020
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 21 Years to 55 Years
Eligibility 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.

Study Design

Related Conditions & MeSH terms

Intervention

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.
• 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.
• 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.

Locations
Country Name City State
United States Eastern Virginia Medical School Norfolk Virginia

Sponsors (2)
Lead Sponsor Collaborator
Eastern Virginia Medical School National Institute on Drug Abuse (NIDA)

Country where clinical trial is conducted

United States, 

Outcome
Type Measure Description Time frame Safety issue
Primary Plasma Nicotine Change in plasma nicotine level 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.
See also
  Status Clinical Trial Phase
Completed NCT04123041 - Characterize the Nicotine Uptake and Subjective Effects With Use of JUUL Electronic Nicotine Delivery Systems N/A
Completed NCT04107779 - Changes in Biomarkers of Cigarette Smoke Exposure After Switching Either Exclusively or Partly to JUUL ENDS N/A
Completed NCT04620616 - Nicotine Uptake, Measures of Abuse Liability, and Puffing Topography With Use of RELX ENDS Products by ENDS Consumers N/A
Recruiting NCT05306158 - Dual Use Approach Bias Training for Nicotine Addiction N/A
Completed NCT04143256 - Evaluating Selected Constituents in the Exhaled Breath Samples N/A
Completed NCT04088175 - Study to Characterize Puffing Topography With Use of JUUL Electronic Nicotine Delivery Systems (ENDS) in Adult, Closed-System ENDS Consumers N/A
Completed NCT04708106 - Characterization of Product Use in Smokers Switching From Cigarettes to a RELX Electronic Nicotine Delivery System N/A
Recruiting NCT06291597 - Vaping Adverse Lung and Heart Events Cohort
Completed NCT05134415 - Use Behavior, Nicotine Uptake, and Subjective Effects Comparison of Tobacco and Menthol e-Liquids by ENDS Consumers N/A
Completed NCT04640285 - Nicotine Uptake, Measures of Abuse Liability, and Puffing Topography With Use of RELX ENDS Products by Smokers N/A
Recruiting NCT05316727 - Electronic Nicotine Delivery Devices and Potential Progression to Acute Lung Injury
Completed NCT04192032 - Assessing the Effect of Flavor on ENDS Users' Experiences and Exposures N/A
Recruiting NCT05278065 - E-cigarettes for Harm Reduction in Adults With Asthma N/A
Recruiting NCT05206435 - Methadone-Maintained Smokers Switching to E-Cigarettes Phase 4
Completed NCT04316234 - Acute Health Effects of Passive Vape Among COPD Patients N/A
Completed NCT04450537 - PACE Vape Messaging Study N/A
Recruiting NCT05338801 - Effect of Menthol on ENDS Users' Addiction and Exposure N/A
Recruiting NCT05423340 - Effect of E-Liquid Flavor on Respiratory Symptoms in People Using Electronic Nicotine Delivery Systems N/A
Not yet recruiting NCT06063421 - Comparison of Nicotine Replacement Therapy and Electronic Cigarettes for Smoking Cessation in Pakistan N/A
Recruiting NCT05971823 - Effects of Electronic Cigarette Flavors on Abuse Liability in Smokers (P3-Taste) N/A