Recruiting

Tobacco Dependence

Sponsor:

State University of New York at Buffalo

Code:

NCT05772845

Conditions

Acute Abstinence From Cigarettes vs E-cigarettes (ENDS)

Eligibility Criteria

Sex: All

Age: 21 - 50

Healthy Volunteers: Accepted

Interventions

Acute (24-hour) abstinence

Ad libitum smoking/vaping

Study Details

Brief 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.

Conditions

Acute Abstinence From Cigarettes vs E-cigarettes (ENDS)

Study ID

NCT05772845

Start date

Feb 14, 2023

Status verified date

Mar, 2026

Completion date

Nov 30, 2026

Anticipated

Primary completion date

Nov 30, 2026

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 21 - 50

Healthy Volunteers: Accepted

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)

Study Design

Enrollment

370 participants

Anticipated

Allocation

Randomized

Intervention Model

Crossover

Primary purpose

Basic Science

Interventions and Outcome Measures

Arms

other: Daily Users of ENDS

Participants who use nicotine-containing ENDS daily or near-daily but who do NOT smoke combustible cigarettes daily or near-daily.

other: Daily Users of Combustible Cigarettes

Participants who smoke combustible cigarettes daily or near-daily but do NOT use nicotine-containing ENDS daily or near-daily.

other: Daily Dual Users of ENDS and Combustible Cigarettes

Participants who both use nicotine-containing ENDS and combustible cigarettes daily or near-daily

Interventions

Acute (24-hour) abstinence

Participants will be asked to abstain from all tobacco/nicotine for 24 hours prior to the visit

Ad libitum smoking/vaping

Participants will be asked to smoke/vape as usual during the 24 hours prior to the visit

Primary outcome measure

  • Wisconsin Smoking Withdrawal Scale - anger 0.5 [ Time Frame: 0.5 hours ]
  • Wisconsin Smoking Withdrawal Scale - anger 2.5 [ Time Frame: 2.5 hours ]
  • Wisconsin Smoking Withdrawal Scale - anx 0.5 [ Time Frame: 0.5 hours ]
  • Wisconsin Smoking Withdrawal Scale - anx 2.5 [ Time Frame: 2.5 hours ]
  • Wisconsin Smoking Withdrawal Scale - sad 0.5 [ Time Frame: 0.5 hours ]
  • Wisconsin Smoking Withdrawal Scale - sad 2.5 [ Time Frame: 2.5 hours ]
  • Wisconsin Smoking Withdrawal Scale - conc 0.5 [ Time Frame: 0.5 hours ]
  • Wisconsin Smoking Withdrawal Scale - conc 2.5 [ Time Frame: 2.5 hours ]
  • Wisconsin Smoking Withdrawal Scale - sleep 0.5 [ Time Frame: 0.5 hours ]
  • Wisconsin Smoking Withdrawal Scale - sleep 2.5 [ Time Frame: 2.5 hours ]
  • Wisconsin Smoking Withdrawal Scale - appetite 0.5 [ Time Frame: 0.5 hours ]
  • Wisconsin Smoking Withdrawal Scale - appetite 2.5 [ Time Frame: 2.5 hours ]
  • Mood and Physical Symptoms Scale - 0.5 [ Time Frame: 0.5 hours ]
  • Mood and Physical Symptoms Scale - 2.5 [ Time Frame: 2.5 hours ]
  • Minnesota Nicotine Withdrawal Scale - 0.5 [ Time Frame: 0.5 hours ]
  • Minnesota Nicotine Withdrawal Scale - 2.5 [ Time Frame: 2.5 hours ]
  • Positive and Negative Affect Scale - PA 0.5 [ Time Frame: 0.5 hours ]
  • Positive and Negative Affect Scale - PA 2.5 [ Time Frame: 2.5 hours ]
  • Positive and Negative Affect Scale - NA 0.5 [ Time Frame: 0.5 hours ]
  • Positive and Negative Affect Scale - NA 2.5 [ Time Frame: 2.5 hours ]
  • Snaith-Hamilton Pleasure Scale 0.5 [ Time Frame: 0.5 hours ]
  • Snaith-Hamilton Pleasure Scale 2.5 [ Time Frame: 2.5 hours ]
  • Questionnaire on Vaping Craving 0.5 [ Time Frame: 0.5 hours ]
  • Questionnaire on Vaping Craving 2.5 [ Time Frame: 2.5 hours ]
  • Questionnaire on Smoking Urges - Brief 0.5 [ Time Frame: 0.5 hours ]
  • Questionnaire on Smoking Urges - Brief 2.5 [ Time Frame: 2.5 hours ]
  • PhenX Toolkit Insomnia Severity Index 0.5 [ Time Frame: 0.5 hours ]
  • PhenX Toolkit Insomnia Severity Index 2.5 [ Time Frame: 2.5 hours ]
  • Restlessness ratings 0.5 [ Time Frame: 0.5 hours ]
  • Restlessness ratings 2.5 [ Time Frame: 2.5 hours ]
  • Restlessness and Agitation Questionnaire - Modified 0.5 [ Time Frame: 0.5 hours ]
  • Restlessness and Agitation Questionnaire - Modified 2.5 [ Time Frame: 2.5 hours ]
  • Identical Pair Continuous Performance Task [ Time Frame: ~2 hours ]
  • n-back working memory task [ Time Frame: ~2 hours ]
  • Stop signal reaction time task [ Time Frame: ~2 hours ]
  • kcal consumed [ Time Frame: 3 hours ]
  • Hypothetical commodity purchase task - vaping intensity 0.5 [ Time Frame: 0.5 hours ]
  • Hypothetical commodity purchase task - vaping intensity 2.5 [ Time Frame: 2.5 hours ]
  • Hypothetical commodity purchase task - vaping persistence 0.5 [ Time Frame: 0.5 hours ]
  • Hypothetical commodity purchase task - vaping persistence 2.5 [ Time Frame: 2.5 hours ]
  • Hypothetical commodity purchase task - smoking intensity 0.5 [ Time Frame: 0.5 hours ]
  • Hypothetical commodity purchase task - smoking intensity 0.5 [ Time Frame: 2.5 hours ]
  • Hypothetical commodity purchase task - smoking persistence 0.5 [ Time Frame: 0.5 hours ]
  • Hypothetical commodity purchase task - smoking persistence 2.5 [ Time Frame: 2.5 hours ]
  • Choice Behavior Under Cued Conditions (CBUCC) Task - spend vape [ Time Frame: 3 hours ]
  • Choice Behavior Under Cued Conditions (CBUCC) Task - spend cig [ Time Frame: 3 hours ]
  • Choice Behavior Under Cued Conditions (CBUCC) Task - spend water [ Time Frame: 3 hours ]
  • Choice Behavior Under Cued Conditions (CBUCC) Task - crave vape [ Time Frame: 3 hours ]
  • Choice Behavior Under Cued Conditions (CBUCC) Task - crave cig [ Time Frame: 3 hours ]

Central Contacts and Locations

Central contacts

Larry Hawk, PhD

716-645-0192lhawk@buffalo.edu

Locations

University at Buffalo

Recruiting

Buffalo, New York, United States, 14260

Contacts

Larry Hawk, PhD

7166450192lhawk@buffalo.edu

More Information

Sponsor

State University of New York at Buffalo

Last update posted

Mar 9, 2026

Last verified

Mar, 2026

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by State University of New York at Buffalo on 2026-03-09.