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

NCT06602492 · Status: COMPLETED · Phase: EARLY_PHASE1 · Type: INTERVENTIONAL · Enrollment: 72

Last updated 2024-09-27

No results posted yet for this study

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

Interventions

DRUG

Lower nicotine e-liquid

A 3% nicotine concentration eliquid.

DRUG

Higher nicotine eliquid

A 5% nicotine concentration eliquid.

Sponsors & Collaborators

  • Rochester Institute of Technology

    lead OTHER

Principal Investigators

  • Risa J Robinson, PhD in Mechanical Engineering · Rochester Institute of Technology

  • Edward C Hensel, PhD in Mechanical Engineering · Rochester Institute of Technology

  • Stephanie Godleski, PhD in Clinical Psychology · Rochester Institute of Technology

  • Nathan Eddingsaas, PhD in Chemistry · Rochester Institute of Technology

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
21 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-07-15
Primary Completion
2023-11-15
Completion
2023-11-15
FDA Drug
Yes

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06602492 on ClinicalTrials.gov