Vaping and Smoking Project in People With Schizophrenia

Официальное название

A Laboratory Study of Behavior and Performance Among People Who Vape Nicotine and/or Smoke Cigarettes - Schizophrenia Supplement

Обзор

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.

Подробное описание

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.

Вмешательства

• Поведенческое Acute (24-hour) abstinence
  Participants will be asked to abstain from all tobacco/nicotine for 24 hours prior to the visit
• Поведенческое Ad libitum smoking/vaping
  Participants will be asked to smoke/vape as usual during the 24 hours prior to the visit

Первичные конечные точки

• Wisconsin Smoking Withdrawal Scale - anger 0.5 [Срок оценки: 0.5 hours]
• Wisconsin Smoking Withdrawal Scale - anger 2.5 [Срок оценки: 2.5 hours]
• Wisconsin Smoking Withdrawal Scale - anxiety 0.5 [Срок оценки: 0.5 hours]
• Wisconsin Smoking Withdrawal Scale - anxiety 2.5 [Срок оценки: 2.5 hours]
• Wisconsin Smoking Withdrawal Scale - sad 0.5 [Срок оценки: 0.5 hours]
• Wisconsin Smoking Withdrawal Scale - sad 2.5 [Срок оценки: 2.5 hours]
• Wisconsin Smoking Withdrawal Scale - conc 0.5 [Срок оценки: 0.5 hours]
• Wisconsin Smoking Withdrawal Scale - conc 2.5 [Срок оценки: 2.5 hours]
• Wisconsin Smoking Withdrawal Scale - sleep 0.5 [Срок оценки: 0.5 hours]
• Wisconsin Smoking Withdrawal Scale - sleep 2.5 [Срок оценки: 2.5 hours]

Вторичные конечные точки (10)

• modified Cigarette evaluation questionnaire [Срок оценки: 3.5 hours]
• modified e-Cigarette evaluation questionnaire [Срок оценки: 3.5 hours]
• Somatic / side effect checklist 0.5 [Срок оценки: 0.5 hours]
• Somatic / side effect checklist 2.5 [Срок оценки: 2.5 hours]
• Heart rate 30 [Срок оценки: 30 minutes]
• Heart rate 60 [Срок оценки: 60 minutes]
• Heart rate 90 [Срок оценки: 90 minutes]
• Heart rate 120 [Срок оценки: 120 minutes]
• Heart rate 150 [Срок оценки: 150 minutes]
• Heart rate 180 [Срок оценки: 180 minutes]

Критерии участия

Критерии включения

• 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)

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Перекрёстный дизайн

Маскирование

Открытое

Основная цель

Фундаментальное исследование

Центры проведения

США · 1 центр

• University at Buffalo — Buffalo

Идентификаторы

NCT: NCT06944847 · STUDY00006122-Supplement · 3R01DA054276-03S1

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

Открыть это исследование на ClinicalTrials.gov ↗