Comparing withdrawal symptoms between vapers and smokers
A Controlled Evaluation of Abstinence-Induced Withdrawal and Motivation to Vape/Smoke Among Daily ENDS Users vs. Cigarette Smokers
This study is trying to see how withdrawal symptoms differ between people who vape and those who smoke cigarettes to better understand nicotine dependence.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 370 (estimated) |
| Ages | 21 Years to 50 Years |
| Sex | All |
| Sponsor | State University of New York at Buffalo Academic / other |
| Locations | 1 site (Buffalo, New York) |
| Trial ID | NCT05772845 on ClinicalTrials.gov |
What this trial studies
This research aims to systematically compare the withdrawal experiences of daily vapers using electronic nicotine delivery systems (ENDS) and daily smokers of combustible cigarettes. The study will involve 160 established daily vapers, 160 established daily smokers, and 50 dual users, who will undergo two lab visits after a 24-hour abstinence period. Participants will be assessed on various withdrawal facets such as craving, negative affect, and cognitive difficulties using advanced multi-measure methodologies. The goal is to fill critical gaps in understanding nicotine dependence and contribute to the development of effective therapies for tobacco use.
Who should consider this trial
Good fit: Ideal candidates include individuals who have been daily vapers or smokers for at least six months.
Not a fit: Patients who intend to quit vaping or smoking within the next month may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to improved treatment strategies for individuals struggling with nicotine dependence.
How similar studies have performed: While there is extensive literature on withdrawal from combustible cigarettes, this is the first controlled comparison of withdrawal between vapers and smokers, making it a novel approach.
Eligibility criteria
Show full inclusion / exclusion criteria
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)
Where this trial is running
Buffalo, New York
- University at Buffalo — Buffalo, New York, United States (Recruiting)
Study contacts
- Principal investigator: Larry Hawk, PhD — University at Buffalo
- Study coordinator: Larry Hawk, PhD
- Email: lhawk@buffalo.edu
- Phone: 716-645-0192
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.