Targeted Pharmacological and Behavioral Treatments for Smoking in Schizophrenia Study 1
试验速览
- 阶段
- 2 期
- 状态
- 终止
- 入组人数
- 5
- 试验地点
- 1
- 主要终点
- Questionnaire on Smoking Urges - Brief Form
研究概览
简要总结
Schizophrenia is associated with high rates of cigarette smoking and associated morbidity and mortality. In this study, smokers with schizophrenia will complete a baseline session and then randomized to varenicline (VAR) or placebo (PLA). After 1 week on medication, participants will complete a cigarette rating task session. Participants will then undergo a 72-hr abstinence period in which they will come to the laboratory twice per day and receive high-value cash reinforcement contingent upon meeting a strict breath CO abstinence criterion. At each visit, they will rate withdrawal symptoms, mood and craving. At the end of the abstinence period, they will repeat the cigarette rating task. Participants will return to the lab to provide a CO sample 24 hours later, and will text the lab with videos of their CO samples for one week. Date and time of smoking relapse will be measured from these samples.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Basic Science
- 盲法
- Double (Participant, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Men and women
- •Have schizophrenia or schizoaffective disorder
- •Would like to quit smoking within the next 6 months
- •Have smoked at least 10 cigarettes per day in the past year
- •Have breath CO level > 10 ppm
- •Able to speak, read and comprehend English well enough to complete study procedures
排除标准
- •Pregnant, breast-feeding, or unwilling to use medically-approved contraception
- •Currently using varenicline, bupropion or nicotine replacement therapy for smoking cessation
- •Medical disease that would preclude participation
- •Unstable psychiatric conditions
- •Body mass index (BMI) < 15 or > 38 kg/m2
- •Past-month suicidal intention, with or without a specific plan
- •Positive urine drug screen or breath alcohol level > 0.01% at screening
研究组 & 干预措施
Varenicline
干预措施: Varenicline (Drug)
Placebo
干预措施: Placebo (Drug)
结局指标
主要结局
Questionnaire on Smoking Urges - Brief Form
时间窗: 72 hrs abstinence
Average of all items, rated from 1 (strongly disagree) to 7 (strongly agree). Higher scores indicate higher levels of smoking urge or craving.
Minnesota Nicotine Withdrawal Scale - Negative Affect Scale
时间窗: 72 hrs abstinence
Average of responses to the anger, depression, anxiety and difficulty concentrating items, which are rated from 0 (not present) to 4 (severe).
次要结局
- Modified Cigarette Evaluation Questionnaire - Reward Scale(72 hrs abstinence)
- Latency to Smoking Relapse(1 week)
- Modified Cigarette Evaluation Questionnaire - Satisfaction Scale(72 hrs abstinence)