Clinical trial NCT02825459: Does Abstinence From E-cigarettes Produce Withdrawal Symptoms?
Official title: Does Abstinence From E-cigarettes Produce Withdrawal Symptoms?
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Substance Withdrawal Syndrome
Keywords: abstinence
abuse liability
electronic cigarette
e-cigarette
electronic nicotine delivery device
harm reduction
nicotine
nicotine dependence
smoking
smoking cessation
tobacco
vape
vaping
withdrawal
Lead sponsor: University of Vermont
Sponsor class: OTHER
Collaborators: name: National Cancer Institute (NCI)
First posted: 2016-07-07
Enrollment: 147
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: BASIC_SCIENCE

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.

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.

Eligibility 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

Primary outcomes:
measure: Total score on the Minnesota Nicotine Withdrawal Scale (MNWS)
timeFrame: 6 days
Secondary outcomes:
measure: Individual items on the Minnesota Nicotine Withdrawal Scale (MNWS)
timeFrame: 6 days
measure: Questionnaire of E-cigarette Urges (brief)
timeFrame: 6 days
measure: Questionnaire of Smoking Urges- brief version
timeFrame: 6 days
measure: Heart rate
timeFrame: 6 days
measure: E-cigarette Purchase Task
timeFrame: 6 days
Other outcomes:
Locations:
city: Baltimore
country: United States
facility: Battelle Memorial Institute
state: Maryland
city: Burlington
country: United States
facility: University of Vermont
state: Vermont
Study officials:
affiliation: University of Vermont
name: John R Hughes, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Hughes JR, Peters EN, Callas PW, Peasley-Miklus C, Oga E, Etter JF, Morley N. Withdrawal Symptoms From E-Cigarette Abstinence Among Adult Never-Smokers: A Pilot Experimental Study. Nicotine Tob Res. 2020 Apr 21;22(5):740-746. doi: 10.1093/ntr/ntz169.
citation: Hughes JR, Peters EN, Callas PW, Peasley-Miklus C, Oga E, Etter JF, Morley N. Withdrawal Symptoms From E-Cigarette Abstinence Among Former Smokers: A Pre-Post Clinical Trial. Nicotine Tob Res. 2020 Apr 21;22(5):734-739. doi: 10.1093/ntr/ntz129.