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Does Abstinence From E-cigarettes Produce Withdrawal Symptoms?

Primary Purpose

Substance Withdrawal Syndrome

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Abstinence from e-cigarettes
Sponsored by
University of Vermont
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional basic science trial for Substance Withdrawal Syndrome focused on measuring abstinence, abuse liability, electronic cigarette, e-cigarette, electronic nicotine delivery device, harm reduction, nicotine, nicotine dependence, smoking, smoking cessation, tobacco, vape, vaping, withdrawal

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesAccepts 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

Sites / Locations

  • Battelle Memorial Institute
  • University of Vermont

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Abstinence from e-cigarettes

E-cigarette use

Arm Description

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

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

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Individual items on the Minnesota Nicotine Withdrawal Scale (MNWS)
The investigators will use the mean score for each of the 16 symptoms across participants during abstinence and use conditions.
Questionnaire of E-cigarette Urges (brief)
This is a revision of the brief version Questionnaire of Smoking Urges that asks about urges for e-cigarettes rather than tobacco cigarettes.
Questionnaire of Smoking Urges- brief version
This 2-item scale asks about intensity and frequency of urges.
Heart rate
Measured for 30 sec after sitting for 15 minutes
E-cigarette Purchase Task
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.

Full Information

First Posted
June 28, 2016
Last Updated
November 19, 2018
Sponsor
University of Vermont
Collaborators
National Cancer Institute (NCI)
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1. Study Identification

Unique Protocol Identification Number
NCT02825459
Brief Title
Does Abstinence From E-cigarettes Produce Withdrawal Symptoms?
Official Title
Does Abstinence From E-cigarettes Produce Withdrawal Symptoms?
Study Type
Interventional

2. Study Status

Record Verification Date
November 2018
Overall Recruitment Status
Completed
Study Start Date
July 2016 (undefined)
Primary Completion Date
October 31, 2018 (Actual)
Study Completion Date
October 31, 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Vermont
Collaborators
National Cancer Institute (NCI)

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
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

7. Study Design

Primary Purpose
Basic Science
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
147 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Abstinence from e-cigarettes
Arm Type
Experimental
Arm Description
Participants abstain from e-cigarettes and other nicotine/tobacco products for 6 days
Arm Title
E-cigarette use
Arm Type
No Intervention
Arm Description
Participants use e-cigarettes and continue to abstain from tobacco/nicotine products as they normally would.
Intervention Type
Behavioral
Intervention Name(s)
Abstinence from e-cigarettes
Intervention Description
Abrupt cessation for 6 days
Primary Outcome Measure Information:
Title
Total score on the Minnesota Nicotine Withdrawal Scale (MNWS)
Description
The investigators will compare the mean score across participants for the entire 6-day abstinence vs. use conditions.
Time Frame
6 days
Secondary Outcome Measure Information:
Title
Individual items on the Minnesota Nicotine Withdrawal Scale (MNWS)
Description
The investigators will use the mean score for each of the 16 symptoms across participants during abstinence and use conditions.
Time Frame
6 days
Title
Questionnaire of E-cigarette Urges (brief)
Description
This is a revision of the brief version Questionnaire of Smoking Urges that asks about urges for e-cigarettes rather than tobacco cigarettes.
Time Frame
6 days
Title
Questionnaire of Smoking Urges- brief version
Description
This 2-item scale asks about intensity and frequency of urges.
Time Frame
6 days
Title
Heart rate
Description
Measured for 30 sec after sitting for 15 minutes
Time Frame
6 days
Title
E-cigarette Purchase Task
Description
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.
Time Frame
6 days

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
John R Hughes, MD
Organizational Affiliation
University of Vermont
Official's Role
Principal Investigator
Facility Information:
Facility Name
Battelle Memorial Institute
City
Baltimore
State/Province
Maryland
ZIP/Postal Code
21209
Country
United States
Facility Name
University of Vermont
City
Burlington
State/Province
Vermont
ZIP/Postal Code
05401
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
31504882
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.
Results Reference
derived
PubMed Identifier
31352486
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.
Results Reference
derived

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Does Abstinence From E-cigarettes Produce Withdrawal Symptoms?

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