Does Abstinence From E-cigarettes Produce Withdrawal Symptoms?

University of Vermont

Status

Completed

Conditions

Substance Withdrawal Syndrome

Treatments

Behavioral: Abstinence from e-cigarettes

Study type

Interventional

Funder types

Other

NIH

Identifiers

NCT02825459

R01CA192940-01 (U.S. NIH Grant/Contract)

1R01CA192940-01

Details and patient eligibility

About

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.

Full 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.

Enrollment

147 patients

Sex

All

Ages

18+ years old

Volunteers

Accepts Healthy Volunteers

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