Does Abstinence From E-cigarettes Produce Withdrawal Symptoms?
| Status: | Completed |
|---|---|
| Conditions: | Psychiatric |
| Therapuetic Areas: | Psychiatry / Psychology |
| Healthy: | No |
| Age Range: | 18 - Any |
| Updated: | 11/22/2018 |
| Start Date: | July 2016 |
| End Date: | October 31, 2018 |
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.
symptoms of nicotine withdrawal when they stop using e-cigarettes for 6 days.
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.
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.
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
We found this trial at
2
sites
University of Vermont The University of Vermont combines faculty-student relationships most commonly found in a...
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