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Completed

NCT Number: NCT02825459

Does Abstinence From E-cigarettes Produce Withdrawal Symptoms?

The purpose of this study is to see whether adults who use e-cigarettes every day experience symptoms of nicotine withdrawal when they stop using e-cigarettes for 6 days.

Completed

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Battelle Memorial Institute, Baltimore, Maryland, United States

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About this study

Study Design: The investigators will recruit 120 individuals who are long-term daily and exclusive users of nicotine-containing e-cigarettes. Participants will be asked to use their own e-cigarette as usual during the first week of the study and to then stop their use of e-cigarettes for 6 days. The total study duration will be 14 days. Participants will be instructed to continue abstinence from other tobacco and nicotine products during the entire study. The investigators will use an escalating payment system with bonuses based on breath and urine samples to encourage compliance.

Every day during the study, participants will report e-cigarette and tobacco cigarette use and monitor symptoms of nicotine withdrawal via a phone call to an Interactive Voice Response system. Participants will attend 3 study visits each week to provide urine and breath samples to verify compliance, and to complete brief surveys.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 18 years or older
  • Able to read and understand verbal English fluently
  • US citizen or resident alien
  • Primarily uses e-cigarette product types of refillable tanks or modified devices
  • Uses nicotine-containing e-liquid
  • Has baseline urinary cotinine concentration of > 100 ng/ml
  • Has used e-cigarettes daily for the last 2 months
  • Has a home or cell phone
  • Agrees to abstain from tobacco, marijuana and other illegal drugs during study

Exclusion criteria

  • Smoked > 5 tobacco cigarettes in the last month
  • Used non-cigarette nicotine, tobacco or quit smoking products on >5 days in the past month
  • Use of cannabis (either marijuana or synthetic cannabis) > 5 times in the past month or positive test for cannabis use at screening
  • Current (last 6 months) Generalized Anxiety Disorder, Major Depressive Disorder, Attention Deficit Hyperactivity Disorder or moderate/severe Substance Abuse Disorder
  • Multiple legal, social health, work or school problems in the past month due to alcohol or drug use
  • Pregnant or breastfeeding
  • Previously a participant in the current study
  • Use of prescribed or non-prescribed psychoactive medication > 5 times in the past month
  • Expired carbon monoxide level > 8ppm

Treatment and study plan

Abstinence from e-cigarettes

Behavioral

Abrupt cessation for 6 days

Primary outcomes

  1. Total score on the Minnesota Nicotine Withdrawal Scale (MNWS)

    Time frame: 6 days

    The investigators will compare the mean score across participants for the entire 6-day abstinence vs. use conditions.

Secondary outcomes

  1. Individual items on the Minnesota Nicotine Withdrawal Scale (MNWS)

    Time frame: 6 days

    The investigators will use the mean score for each of the 16 symptoms across participants during abstinence and use conditions.

  2. Questionnaire of E-cigarette Urges (brief)

    Time frame: 6 days

    This is a revision of the brief version Questionnaire of Smoking Urges that asks about urges for e-cigarettes rather than tobacco cigarettes.

  3. Questionnaire of Smoking Urges- brief version

    Time frame: 6 days

    This 2-item scale asks about intensity and frequency of urges.

  4. Heart rate

    Time frame: 6 days

    Measured for 30 sec after sitting for 15 minutes

  5. E-cigarette Purchase Task

    Time frame: 6 days

    This is a modification of the Cigarette Purchase Task that asks how much users would expend to obtain their usual amount of e-liquids to use.

Sponsors and collaborators

Lead sponsor

University of Vermont

Other

Collaborators

  • National Cancer Institute (NCI)

Registry information

Important dates

Study start
2016
Primary completion
2018
Study completion
2018
First posted
Jul 7, 2016
Registry last updated
Nov 20, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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