Does Abstinence From E-cigarettes Produce Withdrawal Symptoms?
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|ClinicalTrials.gov Identifier: NCT02825459|
Recruitment Status : Completed
First Posted : July 7, 2016
Last Update Posted : November 20, 2018
|Condition or disease||Intervention/treatment||Phase|
|Substance Withdrawal Syndrome||Behavioral: Abstinence from e-cigarettes||Not Applicable|
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.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||147 participants|
|Intervention Model:||Crossover Assignment|
|Masking:||None (Open Label)|
|Primary Purpose:||Basic Science|
|Official Title:||Does Abstinence From E-cigarettes Produce Withdrawal Symptoms?|
|Study Start Date :||July 2016|
|Actual Primary Completion Date :||October 31, 2018|
|Actual Study Completion Date :||October 31, 2018|
Experimental: Abstinence from e-cigarettes
Participants abstain from e-cigarettes and other nicotine/tobacco products for 6 days
Behavioral: Abstinence from e-cigarettes
Abrupt cessation for 6 days
No Intervention: E-cigarette use
Participants use e-cigarettes and continue to abstain from tobacco/nicotine products as they normally would.
- Total score on the Minnesota Nicotine Withdrawal Scale (MNWS) [ Time Frame: 6 days ]The investigators will compare the mean score across participants for the entire 6-day abstinence vs. use conditions.
- Individual items on the Minnesota Nicotine Withdrawal Scale (MNWS) [ Time Frame: 6 days ]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) [ Time Frame: 6 days ]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 [ Time Frame: 6 days ]This 2-item scale asks about intensity and frequency of urges.
- Heart rate [ Time Frame: 6 days ]Measured for 30 sec after sitting for 15 minutes
- E-cigarette Purchase Task [ Time Frame: 6 days ]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.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02825459
|United States, Maryland|
|Battelle Memorial Institute|
|Baltimore, Maryland, United States, 21209|
|United States, Vermont|
|University of Vermont|
|Burlington, Vermont, United States, 05401|
|Principal Investigator:||John R Hughes, MD||University of Vermont|