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Does Abstinence From E-cigarettes Produce Withdrawal Symptoms?

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ClinicalTrials.gov Identifier: NCT02825459
Recruitment Status : Completed
First Posted : July 7, 2016
Last Update Posted : November 20, 2018
Sponsor:
Collaborator:
National Cancer Institute (NCI)
Information provided by (Responsible Party):
John Hughes, University of Vermont

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Substance Withdrawal Syndrome Behavioral: Abstinence from e-cigarettes Not Applicable

Detailed Description:

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 147 participants
Allocation: Non-Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)
Primary Purpose: Basic Science
Official Title: Does Abstinence From E-cigarettes Produce Withdrawal Symptoms?
Study Start Date : July 2016
Actual Primary Completion Date : October 31, 2018
Actual Study Completion Date : October 31, 2018

Resource links provided by the National Library of Medicine

MedlinePlus related topics: E-Cigarettes

Arm Intervention/treatment
Experimental: Abstinence from e-cigarettes
Participants abstain from e-cigarettes and other nicotine/tobacco products for 6 days
Behavioral: Abstinence from e-cigarettes
Abrupt cessation for 6 days

No Intervention: E-cigarette use
Participants use e-cigarettes and continue to abstain from tobacco/nicotine products as they normally would.



Primary Outcome Measures :
  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 Outcome Measures :
  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.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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

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): NCT02825459


Locations
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United States, Maryland
Battelle Memorial Institute
Baltimore, Maryland, United States, 21209
United States, Vermont
University of Vermont
Burlington, Vermont, United States, 05401
Sponsors and Collaborators
University of Vermont
National Cancer Institute (NCI)
Investigators
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Principal Investigator: John R Hughes, MD University of Vermont
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: John Hughes, Faculty, Department of Psychiatry, University of Vermont
ClinicalTrials.gov Identifier: NCT02825459    
Other Study ID Numbers: 1R01CA192940-01 ( U.S. NIH Grant/Contract )
R01CA192940-01 ( U.S. NIH Grant/Contract )
First Posted: July 7, 2016    Key Record Dates
Last Update Posted: November 20, 2018
Last Verified: November 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Keywords provided by John Hughes, University of Vermont:
abstinence
abuse liability
electronic cigarette
e-cigarette
electronic nicotine delivery device
harm reduction
nicotine
nicotine dependence
smoking
smoking cessation
tobacco
vape
vaping
withdrawal
Additional relevant MeSH terms:
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Substance Withdrawal Syndrome
Substance-Related Disorders
Chemically-Induced Disorders
Mental Disorders