RecruitingNot Applicable

Vaping and Smoking Withdrawal Project

United States370 participantsStarted 2023-02-14

Plain-language summary

The proposed research, which will systematically and comprehensively characterize the withdrawal among daily vapers compared to daily smokers of combustible cigarettes, filling critical gaps in the understanding of electronic nicotine delivery systems (ENDS) dependence/abuse liability and contributing to the development of therapies for tobacco/nicotine use, the leading preventable cause of death in the US.

Who can participate

Age range

21 Years – 50 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: * 6+ months of daily/near-daily nicotine vaping and/or cigarette smoking (to yield 160 vapers, 160 smokers, 50 dual users) * 200+ ng/mL cotinine on a commercially-available quick screen Current Exclusion Criteria: * intention to quit daily/near-daily vaping/smoking in the next month * current (2+ days out of the past 7) use of pipe tobacco, hookah/shisha, smokeless tobacco, dissolvable tobacco, nicotine pouches. For vaping group only, current (2+ days out of past 7) use of cigars, cigarillos, or filtered cigars that are filled with tobacco or a mix of tobacco and marijuana * current use of any smoking cessation medication * current severe substance dependence other than tobacco/nicotine (including cannabis; NIDA Modified ASSIST of 27+) * current (past 2 weeks) suicidal ideation with intent and/or plan * current antipsychotic medications or lifetime history of schizophrenia or bipolar disorder * pregnancy (intake urine screen) Original Exclusion Criteria that have been modified or eliminated: * \>1 use in past month of tobacco/nicotine products other than ENDS and combustible cigarettes (modified 5/19/25 - see current exclusion criteria) * alcohol: AUDIT \> 15 for males and \>13 for females (eliminated 7/25/23) * current major depression (PHQ-9\>11) (eliminated 7/25/23) * suicide risk (answer to question #9 on PHQ-9 is anything other than "Not at all") (modified 11/17/23 - see current exclusion criteria)

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Wisconsin Smoking Withdrawal Scale - anger 0.5

Timeframe: 0.5 hours

Wisconsin Smoking Withdrawal Scale - anger 2.5

Timeframe: 2.5 hours

Wisconsin Smoking Withdrawal Scale - anx 0.5

Timeframe: 0.5 hours

Wisconsin Smoking Withdrawal Scale - anx 2.5

Timeframe: 2.5 hours

Wisconsin Smoking Withdrawal Scale - sad 0.5

Timeframe: 0.5 hours

Wisconsin Smoking Withdrawal Scale - sad 2.5

Timeframe: 2.5 hours

Wisconsin Smoking Withdrawal Scale - conc 0.5

Timeframe: 0.5 hours

Wisconsin Smoking Withdrawal Scale - conc 2.5

Trial details

NCT IDNCT05772845

SponsorState University of New York at Buffalo

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2026-11-30

Contact for this trial

Larry Hawk, PhD

716-645-0192 lhawk@buffalo.edu

View on ClinicalTrials.gov More Acute Abstinence From Cigarettes vs E-cigarettes (ENDS) trials

Plain-language summary

Who can participate

Age range

21 Years – 50 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

What they're measuring

Wisconsin Smoking Withdrawal Scale - anger 0.5

Timeframe: 0.5 hours

Wisconsin Smoking Withdrawal Scale - anger 2.5

Timeframe: 2.5 hours

Wisconsin Smoking Withdrawal Scale - anx 0.5

Timeframe: 0.5 hours

Wisconsin Smoking Withdrawal Scale - anx 2.5

Timeframe: 2.5 hours

Wisconsin Smoking Withdrawal Scale - sad 0.5

Timeframe: 0.5 hours

Wisconsin Smoking Withdrawal Scale - sad 2.5

Timeframe: 2.5 hours

Wisconsin Smoking Withdrawal Scale - conc 0.5

Timeframe: 0.5 hours

Wisconsin Smoking Withdrawal Scale - conc 2.5