Biological and Behavioral Mechanisms of Smoking in Schizophrenia
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 75
- 试验地点
- 1
- 主要终点
- Preferred Brand Smoke Intake (CO)
研究概览
简要总结
The objective of this study is to investigate the relative contributions of nicotine replacement and sensorimotor replacement (i.e., smoking denicotinized cigarettes) on abstinence-induced smoking urges, withdrawal-related negative affect, psychiatric symptoms, cognitive task performance and 90-min ad libitum usual-brand smoking behavior in smokers with schizophrenia and non-psychiatric smokers.
详细描述
This study used a mixed between- and within-subjects design to investigate the separate and combined effects of sensorimotor replacement for smoking (very low nicotine content [VLNC] cigarettes vs. no cigarettes) and transdermal nicotine replacement (42 mg nicotine [NIC] vs. placebo [PLA] patches) in smokers with schizophrenia and control smokers without psychiatric illness. Each session contained a 5-h controlled administration period in which participants underwent the following conditions, in counterbalanced order: VLNC + NIC, VLNC + PLA, no cigarettes + NIC, no cigarettes + PLA, Usual Brand cigarettes + no patches. Next, participants completed measures of cigarette craving, nicotine withdrawal, smoking habit withdrawal, cigarette subjective effects, psychiatric symptoms and cognitive task performance followed by a 90-min period of ad libitum usual-brand smoking.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Basic Science
- 盲法
- Double (Participant, Outcomes Assessor)
盲法说明
Participants and outcomes assessor were blind to patch condition (NIC or PLA)
入排标准
- 年龄范围
- 18 Years 至 99 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •schizophrenia or no psychiatric illness
- •18 and older
- •men and women
- •cigarette smokers, 20-50 cigarettes per day
- •would like to quit someday
排除标准
- •medical conditions excluding transdermal nicotine replacement
- •pregnancy or lactation
研究组 & 干预措施
Active nicotine replacement (NRT) + denicotinized cigarettes
42 mg nicotine replacement plus sensorimotor replacement
干预措施: sensorimotor replacement (Behavioral)
Active nicotine replacement (NRT) + denicotinized cigarettes
42 mg nicotine replacement plus sensorimotor replacement
干预措施: 42 mg transdermal nicotine replacement (Drug)
Placebo NRT + denicotinized cigarettes
inactive transdermal patches plus sensorimotor replacement
干预措施: sensorimotor replacement (Behavioral)
Placebo NRT + denicotinized cigarettes
inactive transdermal patches plus sensorimotor replacement
干预措施: Placebo transdermal nicotine (Drug)
Active NRT + no cigarettes
42 mg nicotine replacement with no sensorimotor replacement
干预措施: 42 mg transdermal nicotine replacement (Drug)
Placebo NRT + No cigarettes
Double placebo: No nicotine or sensorimotor replacement
干预措施: Placebo transdermal nicotine (Drug)
usual brand smoking
positive control: usual brand smoking
干预措施: usual brand smoking (Other)
结局指标
主要结局
Preferred Brand Smoke Intake (CO)
时间窗: 90 min
preferred brand smoke intake (breath CO) after 5-hr "satiation" periods in which nicotine replacement and sensorimotor replacement were provided under double-blind conditions
次要结局
- Questionnaire on Smoking Urges - Brief Scale (QSU-Brief)(5 hr)
研究者
Jennifer Tidey
Associate Professor (Research)
Brown University