Does Abstinence From E-cigarettes Produce Withdrawal Symptoms?

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

147 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-07-31

Study Completion Date

2018-10-31

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Substance Withdrawal Syndrome

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

NONE

Study Groups

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Abstinence from e-cigarettes

Participants abstain from e-cigarettes and other nicotine/tobacco products for 6 days

Group Type EXPERIMENTAL

Abstinence from e-cigarettes

Intervention Type BEHAVIORAL

Abrupt cessation for 6 days

E-cigarette use

Participants use e-cigarettes and continue to abstain from tobacco/nicotine products as they normally would.

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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Abstinence from e-cigarettes

Abrupt cessation for 6 days

Intervention Type BEHAVIORAL

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes