Recruiting

Vaping & Smoking

Sponsor:

State University of New York at Buffalo

Code:

NCT06944847

Conditions

Acute Abstinence From Cigarettes vs E-cigarettes (ENDS)

Eligibility Criteria

Sex: All

Age: 21 - 50

Healthy Volunteers: Not accepted

Interventions

Acute (24-hour) abstinence

Ad libitum smoking/vaping

Study Details

Brief summary:

The proposed research will characterize withdrawal among people with schizophrenia who vape daily compared to people with schizophrenia who smoke combustible cigarettes daily, filling critical gaps in the understanding of electronic nicotine delivery systems (ENDS) dependence and contributing to the development of vaping cessation interventions amongst people with schizophrenia, the leading preventable cause of death in the US.

Conditions

Acute Abstinence From Cigarettes vs E-cigarettes (ENDS)

Study ID

NCT06944847

Start date

Feb 15, 2025

Status verified date

Mar, 2026

Completion date

Apr 1, 2027

Anticipated

Primary completion date

Apr 1, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 21 - 50

Healthy Volunteers: Not accepted

Inclusion Criteria:

  • 6+ months of daily/near-daily nicotine vaping or cigarette smoking
  • 200+ ng/mL cotinine on a commercially-available quick screen
  • stable antipsychotic medication dose (no changes in past 6 months).

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
  • pregnancy (intake urine screen)
  • florid psychosis or severe cognitive symptoms (score of ≥5 on PANSS items delusions (P1), hallucinatory behavior (P3), or unusual thought content (G9), conceptual disorganization (P2), abstract thinking (N5), or poor attention (G11) or a score ≥6 on grandiosity (P5) or suspiciousness (P6)

Study Design

Enrollment

64 participants

Anticipated

Allocation

Randomized

Intervention Model

Crossover

Primary purpose

Basic Science

Interventions and Outcome Measures

Arms

other: Daily use 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 use of combustible cigarettes

Participants who smoke combustible cigarettes daily or near-daily but do NOT use nicotine-containing ENDS 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 - anxiety 0.5 [ Time Frame: 0.5 hours ]
  • Wisconsin Smoking Withdrawal Scale - anxiety 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 NA 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 PA 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 ]
  • 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 ]
  • Questionnaire on Smoking Urges - Brief 2.5 [ Time Frame: 2.5 ]
  • PhenX Toolkit Insomnia Severity Index 0.5 [ Time Frame: 0.5 ]
  • PhenX Toolkit Insomnia Severity Index 2.5 [ Time Frame: 2.5 hours ]
  • Restlessness ratings 0.5 [ Time Frame: 0.5 ]
  • Restlessness ratings 2.5 [ Time Frame: 2.5 hours ]
  • Restlessness and Agitation Questionnaire 2.5 [ Time Frame: 2.5 hours ]
  • Restlessness and Agitation Questionnaire 0.5 [ Time Frame: 0.5 hours ]
  • Identical Pairs Continuous Performance Task [ Time Frame: Lab visits: ~2 hours ]
  • n-back working memory task [ Time Frame: Lab visit ~ 2hours ]
  • Stop signal reaction time task [ Time Frame: Lab visits: ~2 hours ]
  • Spatial Delayed Response Task [ Time Frame: 2 hours ]
  • kcal consumed [ Time Frame: 3 hours ]
  • Hypothetical Commodity Purchase Tasks vaping intensity 0.5 [ Time Frame: 0.5 hours ]
  • Hypothetical Commodity Purchase Tasks vaping intensity 2.5 [ Time Frame: 2.5 hours ]
  • Hypothetical Commodity Purchase Tasks vaping persistence 0.5 [ Time Frame: 0.5 hours ]
  • Hypothetical Commodity Purchase Tasks vaping persistence 2.5 [ Time Frame: 2.5 hours ]
  • Hypothetical Commodity Purchase Tasks smoking intensity 0.5 [ Time Frame: 0.5 hours ]
  • Hypothetical Commodity Purchase Tasks smoking intensity 2.5 [ Time Frame: 2.5 hours ]
  • Hypothetical Commodity Purchase Tasks smoking persistence 0.5 [ Time Frame: 0.5 hours ]
  • Hypothetical Commodity Purchase Tasks smoking persistence 2.5 [ Time Frame: 2.5 hours ]
  • Positive and Negative Syndrome Scale positive 3 [ Time Frame: 3 hours ]
  • Positive and Negative Syndrome Scale negative 3 [ Time Frame: 3 hours ]
  • Positive and Negative Syndrome Scale general 3 [ 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

716-645-0192lhawk@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.