Vaping and Smoking Project in People With Schizophrenia (VASP-S)

University at Buffalo (UB)

Status: Enrolling

Conditions: Acute Abstinence From Cigarettes vs E-cigarettes (ENDS)

Treatments: Behavioral: Acute (24-hour) abstinence; Behavioral: Ad libitum smoking/vaping

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT06944847

3R01DA054276-03S1 (U.S. NIH Grant/Contract)

STUDY00006122-Supplement

Details and patient eligibility

About

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.

Full 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 cigarettes), there is currently no research on ENDS withdrawal in people with schizophrenia. The proposed supplement will conduct a systematic and comprehensive characterization of withdrawal in a sample of people with SCZ who vape daily compared to those who smoke daily, filling gaps in our understanding of ENDS dependence/withdrawal for people with SCZ and contributing to the identification of intervention targets for ENDS use.

Enrollment: 64 estimated patients

Sex: All

Ages: 21 to 50 years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

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)

Trial design

Primary purpose: Basic Science

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: None (Open label)

---

64 participants in 2 patient groups

Daily use of ENDS

Other group

Description:

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

Treatment:

Behavioral: Ad libitum smoking/vaping

Behavioral: Acute (24-hour) abstinence

Daily use of combustible cigarettes

Other group

Description:

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

Treatment:

Behavioral: Ad libitum smoking/vaping

Behavioral: Acute (24-hour) abstinence