Does Abstinence From E-cigarettes Produce Withdrawal Symptoms?

Substance Withdrawal Syndrome Clinical Trial

Official title:

Does Abstinence From E-cigarettes Produce Withdrawal Symptoms?

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02825459
• Other study ID #: 1R01CA192940-01
• Secondary ID: R01CA192940-01
• Status: Completed
• Phase: N/A
• Start date: July 2016
• Est. completion date: October 31, 2018

Study information

• Verified date: November 2018
• Source: University of Vermont
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 147
• Est. completion date: October 31, 2018
• Est. primary completion date: October 31, 2018
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Substance Withdrawal Syndrome

Intervention

Behavioral:
• Abstinence from e-cigarettes
Abrupt cessation for 6 days

Locations

Country	Name	City	State
United States	Battelle Memorial Institute	Baltimore	Maryland
United States	University of Vermont	Burlington	Vermont

Sponsors (2)

Lead Sponsor	Collaborator
University of Vermont	National Cancer Institute (NCI)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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.	6 days
Secondary	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.	6 days
Secondary	Questionnaire of Smoking Urges- brief version	This 2-item scale asks about intensity and frequency of urges.	6 days
Secondary	Heart rate	Measured for 30 sec after sitting for 15 minutes	6 days
Secondary	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.	6 days