NCT02825459

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
147

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Jul 2016

Typical duration for not_applicable

Geographic Reach
1 country

2 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

June 28, 2016

Completed
3 days until next milestone

Study Start

First participant enrolled

July 1, 2016

Completed
6 days until next milestone

First Posted

Study publicly available on registry

July 7, 2016

Completed
2.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 31, 2018

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 31, 2018

Completed
Last Updated

November 20, 2018

Status Verified

November 1, 2018

Enrollment Period

2.3 years

First QC Date

June 28, 2016

Last Update Submit

November 19, 2018

Conditions

Substance Withdrawal Syndrome

Keywords

abstinenceabuse liabilityelectronic cigarettee-cigaretteelectronic nicotine delivery deviceharm reductionnicotinenicotine dependencesmokingsmoking cessationtobaccovapevapingwithdrawal

Outcome Measures

Primary Outcomes (1)

  • Total score on the Minnesota Nicotine Withdrawal Scale (MNWS)

    The investigators will compare the mean score across participants for the entire 6-day abstinence vs. use conditions.

    6 days

Secondary Outcomes (5)

  • Individual items on the Minnesota Nicotine Withdrawal Scale (MNWS)

    6 days

  • Questionnaire of E-cigarette Urges (brief)

    6 days

  • Questionnaire of Smoking Urges- brief version

    6 days

  • Heart rate

    6 days

  • E-cigarette Purchase Task

    6 days

Study Arms (2)

Abstinence from e-cigarettes

EXPERIMENTAL

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

Behavioral: Abstinence from e-cigarettes

E-cigarette use

NO INTERVENTION

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

Interventions

Abstinence from e-cigarettesBEHAVIORAL

Abrupt cessation for 6 days

Abstinence from e-cigarettes

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Battelle Memorial Institute

Baltimore, Maryland, 21209, United States

Location

University of Vermont

Burlington, Vermont, 05401, United States

Location

Related Publications (2)

  • 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.

    PMID: 31504882DERIVED

  • 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.

    PMID: 31352486DERIVED

MeSH Terms

Conditions

Substance Withdrawal SyndromeVapingHarm ReductionTobacco Use DisorderSmokingSmoking Cessation

Condition Hierarchy (Ancestors)

Substance-Related DisordersChemically-Induced DisordersMental DisordersBehaviorHealth Behavior

Study Officials

  • John R Hughes, MD

    University of Vermont

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
BASIC SCIENCE
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Faculty, Department of Psychiatry

Study Record Dates

First Submitted

June 28, 2016

First Posted

July 7, 2016

Study Start

July 1, 2016

Primary Completion

October 31, 2018

Study Completion

October 31, 2018

Last Updated

November 20, 2018

Record last verified: 2018-11

Data Sharing

IPD Sharing
Will not share

Locations

US(2)