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E-cigarette Nicotine Study

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ClinicalTrials.gov Identifier: NCT04709471
Recruitment Status : Recruiting
First Posted : January 14, 2021
Last Update Posted : February 3, 2021
Sponsor:
Information provided by (Responsible Party):
Elias Klemperer, University of Vermont

Brief Summary:
This is a pilot randomized controlled trial (RCT) with the overarching aim of testing the influence of reducing electronic nicotine delivery system (ENDS) use or nicotine on addiction and combustible cigarette (CC) smoking among dual users. Specifically, the investigators will conduct a 4-week pilot RCT in which dual users who are not motivated to quit either product in the near future are randomized to A) abruptly switch to low nicotine ENDS pods, B) abruptly reduce number of usual nicotine ENDS pods, or C) use ENDS as usual (control). The investigators adapted a protocol used in a prior study to assign participants to switch to ENDS pods with less nicotine or reduce number of ENDS pods in this trial. Specifically, the investigators will provide all participants with ENDS pods during the study period and instruct them to only use ENDS provided by the study. Participants in reduced nicotine condition will switch from usual nicotine (5% JUUL) to low nicotine ENDS (3% nicotine JUUL) pods. Participants in the reduced use condition will continue to use usual nicotine ENDS (5% nicotine JUUL) pods but reduce use to 60% of their baseline number of pods per week. Participants in the control condition will use usual nicotine ENDS (5% nicotine JUUL) pods as usual.

Condition or disease Intervention/treatment Phase
Nicotine Dependence Electronic Cigarette Use Cigarette Smoking Drug: Nicotine Device: Juul e-cigarette Behavioral: Reduction Phase 2

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 75 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Other
Official Title: Electronic Nicotine Delivery Systems' Influence on Combustible Cigarette Smoking and Demand: A Randomized Controlled Trial
Actual Study Start Date : January 20, 2021
Estimated Primary Completion Date : September 2021
Estimated Study Completion Date : September 2021

Resource links provided by the National Library of Medicine

MedlinePlus related topics: E-Cigarettes

Arm Intervention/treatment
Experimental: Switch to low nicotine e-cigarettes
Switch to e-cigarettes containing 60% of baseline e-cigarette nicotine content.
Drug: Nicotine
Participants will reduce their nicotine intake

Device: Juul e-cigarette
Participants will switch to Juul pods containing less nicotine

Experimental: Reduce number of e-cigarette pods
Reduce e-cigarette use to 60% of baseline number of pods per week.
Drug: Nicotine
Participants will reduce their nicotine intake

Behavioral: Reduction
Participants will reduce the number of Juul pods that they use

No Intervention: Use e-cigarettes as usual
Continue using usual nicotine e-cigarettes as usual.



Primary Outcome Measures :
  1. Feasibility [ Time Frame: Baseline and the four week reduction period ]
    The investigators will assess compliance with study e-cigarettes and compare the percent non-study e-cigarette use between conditions to determine which behavior-changing strategy is more feasible.

  2. Combustible cigarette smoking [ Time Frame: Baseline and the four week reduction period ]
    The investigators will compare change in number of cigarettes per day between conditions.

  3. Cigarette dependence [ Time Frame: Baseline and the four week reduction period ]
    The investigators will compare change in cigarette dependence between conditions using the PATH dependence measure.

  4. E-cigarette dependence [ Time Frame: Baseline and the four week reduction period ]
    The investigators will compare change in e-cigarette dependence between conditions using the PATH dependence measure.


Secondary Outcome Measures :
  1. Cigarette demand [ Time Frame: Baseline and the four week reduction period ]
    The investigators will compare change in cigarette demand using the the Brief Assessment of Cigarette Demand task.

  2. E-cigarette demand [ Time Frame: Baseline and the four week reduction period ]
    The investigators will compare change in e-cigarette demand using a version of the the Brief Assessment of Cigarette Demand task adapted for e-cigarettes.



Information from the National Library of Medicine

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Ages Eligible for Study:   21 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Must be at least 21 years old
  • Must have smoked one ore more CCs in the past 7 days
  • Must have a lifetime history of regular CC smoking
  • Must have used two or more 5% nicotine JUUL pod(s) per week for the past 30 days and vaped in the past week
  • 80% or more of past 30-day ENDS use must be 5% nicotine JUUL pods
  • Must expect to continue smoking CCs and using ECs for the next 7 days
  • Must currently own a JUUL ENDS device
  • Must meet criteria for DSM 5 Tobacco Use Disorder
  • Must have no plans to stop smoking CCs or using ENDS in the next 5 weeks
  • Must be willing to reduce their ENDS use for 4 weeks
  • Has not used non-cigarette or non-ENDS products on 5 or fewer days in the past 30 days
  • Is not currently using nicotine replacement medications, varenicline, or bupropion or receiving smoking cessation counseling
  • Must be willing to commute to the University of Vermont for a single curbside pickup
  • Must have access to a telephone on a daily basis
  • Must be a US citizen or a permanent resident alien with a green card
  • Must be comfortable reading and writing in English and demonstrates comfort speaking in English
  • Must not be currently participating in another study that affects the way they smoke CCs or use ENDS
  • Must have access to a smartphone or tablet with Mac or Android operating system
  • Must have a mailing address where they can receive study supplies
  • Must have an email address and a place to use the internet
  • Is not currently taking methadone or bupenorphrine
  • Is not currently breastfeeding or planning to breastfeed in the next 2 months
  • Must currently live in the state of Vermont
  • Must not be pregnant, planning to become pregnant in the next 2 months, or of reproductive potential, sexually active with a male and not using protection or on birth control. All women who are of reproductive potential will also complete a pregnancy test, whether they report that they are sexually active with a male or not, to verify that they are not pregnant. The investigators will mail pregnancy tests to women of reproductive potential prior to their baseline survey and instruct participants to complete the pregnancy test at home and report the results on the baseline REDCap survey. Participants who report a positive pregnancy test will be provided with women's health resources and removed from the study. The investigators will compensate participants who are removed from the study for all completed study activities. The investigators will exclude pregnant women from this study because the study will provide all participants with nicotine products (i.e., Juul pods) and nicotine causes harm to pregnant women and developing babies.
  • The investigators will assess symptoms of coronavirus and e-cigarette or vaping product use associated lung injury (EVALI) on participants' last survey prior to participants' curbside pickup to limit the amount of time between assessment of symptoms and study product distribution. Participants who report a current coronavirus or diagnosis will be paid for prior study activities and removed from the study. Participants who report symptoms of coronavirus or EVALI will undergo a telephone assessment from the study physician. The study physician will determine if the participant is at risk for coronavirus or EVALI and whether they should be removed from the study. If a participant is removed from the study they will be paid for all prior study activities.
  • People who have reduced CCs or ENDS in the past but not in the last 30 days will be included.

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): NCT04709471


Contacts
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Contact: Elias M Klemperer, PhD 802-656-1641 elias.klemperer@med.uvm.edu

Locations
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United States, Vermont
University of Vermont Recruiting
Burlington, Vermont, United States, 05405
Contact: Shaun Meyers    802-234-1334    shaun.meyers@uvm.edu   
Principal Investigator: Elias M Klemperer, PhD         
Sponsors and Collaborators
University of Vermont
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Responsible Party: Elias Klemperer, Professor, University of Vermont
ClinicalTrials.gov Identifier: NCT04709471    
Other Study ID Numbers: STUDY00001093
First Posted: January 14, 2021    Key Record Dates
Last Update Posted: February 3, 2021
Last Verified: February 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: Yes
Device Product Not Approved or Cleared by U.S. FDA: Yes
Product Manufactured in and Exported from the U.S.: No
Keywords provided by Elias Klemperer, University of Vermont:
Cigarettes
Electronic nicotine delivery systems
Electronic cigarettes
Additional relevant MeSH terms:
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Tobacco Use Disorder
Substance-Related Disorders
Chemically-Induced Disorders
Mental Disorders
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