Does Abstinence From E-cigarettes Produce Withdrawal Symptoms?

November 19, 2018 updated by: John Hughes, University of Vermont
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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

147

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Maryland
      • Baltimore, Maryland, United States, 21209
        • Battelle Memorial Institute
    • Vermont
      • Burlington, Vermont, United States, 05401
        • University of Vermont

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: BASIC_SCIENCE
  • Allocation: NON_RANDOMIZED
  • Interventional Model: CROSSOVER
  • Masking: NONE

Arms and Interventions

Participant Group / 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
6 days

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
6 days
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.
6 days
Questionnaire of Smoking Urges- brief version
Time Frame: 6 days
This 2-item scale asks about intensity and frequency of urges.
6 days
Heart rate
Time Frame: 6 days
Measured for 30 sec after sitting for 15 minutes
6 days
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.
6 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Vermont

Collaborators

National Cancer Institute (NCI)

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

July 1, 2016

Primary Completion (ACTUAL)

October 31, 2018

Study Completion (ACTUAL)

October 31, 2018

Study Registration Dates

First Submitted

June 28, 2016

First Submitted That Met QC Criteria

July 6, 2016

First Posted (ESTIMATE)

July 7, 2016

Study Record Updates

Last Update Posted (ACTUAL)

November 20, 2018

Last Update Submitted That Met QC Criteria

November 19, 2018

Last Verified

November 1, 2018

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 1R01CA192940-01 (NIH)
  • R01CA192940-01 (NIH)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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