Status:

RECRUITING

Vaping and Smoking Project in People With Schizophrenia

Lead Sponsor:

State University of New York at Buffalo

Collaborating Sponsors:

Roswell Park Cancer Institute

National Institute on Drug Abuse (NIDA)

Conditions:

Acute Abstinence From Cigarettes vs E-cigarettes (ENDS)

Eligibility:

All Genders

21-50 years

Phase:

NA

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...

Detailed Description

Although withdrawal is considered a key feature of nicotine/tobacco addiction that contributes to difficulty quitting smoking and likely electronic nicotine delivery systems (ENDS; e.g., electronic ci...

Eligibility Criteria

Inclusion

  • 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

  • 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)

Key Trial Info

Start Date :

February 15 2025

Trial Type :

INTERVENTIONAL

Allocation :

ESTIMATED

End Date :

April 1 2027

Estimated Enrollment :

64 Patients enrolled

Trial Details

Trial ID

NCT06944847

Start Date

February 15 2025

End Date

April 1 2027

Last Update

April 25 2025

Active Locations (1)

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1

University at Buffalo

Buffalo, New York, United States, 14260