Compensatory Behavior of E-cig Users in Response to Reduced Nicotine E-liquids

NCT06602492 | Completed Early Phase 1 FDA Drug

• 1 other identifier: 1R21DA050852
• Study Type: interventional
• Target: 72
• Locations: 1 country
• Sites: 1

Brief Summary

The goal of this clinical trial is to learn if low nicotine eliquids work to reduce exposure to nicotine, in addicted ecig users, without increasing consumption of other harmful constituents. The main questions it aims to answer are:

• Does switching to lower nicotine eliquids change the vaping behavior of addicted ecig users?
• Does switching to lower nicotine eliquids reduce the amount of nicotine consumed? Researchers will compare ecig users who switch from a higher to lower nicotine eliquid to a control group that does not switch. Participants will:
• Complete history of tobacco use and nicotine addiction questionnaires
• Switch from higher to lower nicotine product or control for 15 days
• Complete daily questionnaires to report craving, mood and nicotine withdraw For one full day under each nicotine condition, participants will:
• record puffing behavior using a topography monitor
• wear a sensorized shirt that measures the depth and duration of inhalation, and
• collect a saliva sample at the end of each day

Conditions

Healthy; Nicotine Addiction; Electronic Cigarette Use

Keywords

reduced nicotine eliquid; reduced exposure; cessation

Outcome Measures

Primary Outcomes (1)

• Change in the Total Particular Mass (TPM) exposure when switching from the baseline to the intervention condition (high to low nicotine), based on the novel behavior-based yield model.

  A behavior-based yield model, which combines product emissions with real-world user topography, is used to estimate the Change in Cumulative TPM exposure between low and high nicotine products. Total Particulate Mass (TPM) exposure of nicotine or other Harmful and Potentially Harmful Constituents (HPHCs) increases as a joint function of (1) the TPM delivered from the e-cig to the mouth, (2) the volume of diluting 'clean air' inhaled with the e-cig puff, and (3) the duration of time the emissions are in the lung. TPM exposure is proportional to the product of the TPM, which is the particulate mass contained in each puff delivered to the mouth (quantified by recording the volume of every puff and measuring the associated mass concentration in the emissions), v-inhale, which is the volume of air and entrained ecig aerosol inhaled into the lung with each puff (quantified with a senorized shirt), and t-cycle, which is the total time for the user to inhale each puff, hold their breath an

  From enrollment to the end of 17 days.

Study Arms (2)

Switching Arm: High to Low Nicotine

ACTIVE COMPARATOR

Baselined with a high nicotine eliquid and switched to a low nicotine eliquid.

Drug: Lower nicotine e-liquid

Control Arm: High to High Nicotine

PLACEBO COMPARATOR

Baselined with a high nicotine eliquid and continue with the same high nicotine eliquid.

Drug: Higher nicotine eliquid

Interventions

Lower nicotine e-liquid DRUG

A 3% nicotine concentration eliquid.

Switching Arm: High to Low Nicotine

Higher nicotine eliquid DRUG

A 5% nicotine concentration eliquid.

Control Arm: High to High Nicotine

Eligibility Criteria

• Age: 21 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• years or older
• Regular 30-day e-cig users

You may not qualify if:

• Intention to quit using e-cigs within the next 30 days
• Use of other tobacco products in addition to e-cigs on more than 9 of the previous 30 days
• History of acute or chronic asthma
• Previous diagnosis of cancer
• Other chronic medical conditions
• Use of chronic prescription medications
• Pneumonia in prior six weeks
• Upper respiratory tract infection or other febrile illness in previous 2 weeks
• Smokers on antioxidants, or anti-inflammatory therapy
• Pregnant women or women who intend to become pregnant or breast-feeding
• Had Covid-19 in the past 2 months or still feeling effects from a Covid-19 illness

Sponsors & Collaborators

• Rochester Institute of Technology: lead

Study Sites (1)

Rochester Institute of Technology

Rochester, New York, 14623, United States

Location

MeSH Terms

Conditions

Tobacco Use Disorder; Vaping

Condition Hierarchy (Ancestors)

Substance-Related Disorders; Chemically-Induced Disorders; Mental Disorders; Smoking; Behavior

Study Officials

• Risa J Robinson, PhD in Mechanical Engineering

  Rochester Institute of Technology

  PRINCIPAL INVESTIGATOR

• Edward C Hensel, PhD in Mechanical Engineering

  Rochester Institute of Technology

  STUDY DIRECTOR

• Stephanie Godleski, PhD in Clinical Psychology

  Rochester Institute of Technology

  STUDY DIRECTOR

• Nathan Eddingsaas, PhD in Chemistry

  Rochester Institute of Technology

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: early phase 1
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: September 15, 2024
• First Posted: September 19, 2024
• Study Start: July 15, 2021
• Primary Completion: November 15, 2023
• Study Completion: November 15, 2023
• Last Updated: September 27, 2024

Record last verified: 2024-09

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)