Double-Blind, Placebo-Controlled Trial of Nicotine Nasal Spray as an Aid for Smoking Cessation in Schizophrenia
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 66
- 试验地点
- 1
- 主要终点
- The Number of Subjects Who Quit Smoking From Weeks 5 to 8
研究概览
简要总结
This R01 grant describes a randomized, double-blind, placebo-controlled trial of nicotine nasal spray (NNS) as an aid for smoking cessation in 60 individuals with schizophrenia. The objectives of this study are to determine the efficacy of NNS with behavioral intervention for smoking cessation in smokers with schizophrenia. It is hypothesized that the quit rate of subjects who receive NNS and behavioral intervention will be significantly greater than the quit rate of the control group who will receive the placebo spray plus same behavioral intervention. Quit rate is defined as the proportion of individuals who self report no tobacco use during weeks 5 through 8 confirmed by exhaled carbon monoxide (CO) less than 10 parts per million during these 4 weeks. The investigators will also assess abstinence rates at Study Weeks 12 and 20 on the NNS and at weeks 26 and 52 after the medication has been stopped. Since studies of this group suggest high relapse rates when treatments are discontinued (Evins et al., 2005; George et al., 2000; George et al., 2002a), the investigators will continue NNS treatment for a total of 20 weeks.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Subjects will be invited to participate in the study if they fulfill the following inclusion criteria:
- •Meet DSM-IV diagnostic criteria for Schizophrenia
- •Be 18 years of age or older
- •Be daily smokers of 10 or more cigarettes per day (cpd)
- •Have an expired CO level > 9 ppm
- •Be motivated to quit smoking
- •Be willing to adhere to the study protocol (e.g. provide samples, attend all visits)
- •Be able to give informed consent
- •Stable on their current atypical antipsychotic medication for at least one month.
排除标准
- •Subjects will be excluded based on any one of the following exclusion criteria:
- •Current suicidal risk, including active suicidal ideation, recent suicidal behavior or suicide attempt in the past 30 days,
- •Psychiatric hospitalization in the last 30 days
- •Inability to read or understand the questionnaires in English
- •Current pregnancy or lactation or plans to become pregnant in the next 12 months
- •Regular use of non-cigarette forms of tobacco including cigars, pipes, smokeless tobacco
- •Patients with significant cognitive impairment that may interfere with their study participation assessed as a Folstein Mini-Mental Status exam score of less than 22.
研究组 & 干预措施
Nicotine Nasal Spray
Subjects will be instructed to use the nasal spray at a minimum of 8 doses each day and up to a maximum of 5 doses per hour and 40 doses in 24 hours starting on the TQD. Subjects will be instructed to use the nasal spray at a minimum of 8 doses each day and up to a maximum of 5 doses per hour and 40 doses in 24 hours starting on the TQD. . Nasal spray will be used from the TQD through the end of Week 20.
干预措施: Nicotine Nasal Spray (Drug)
Nicotine Nasal Spray
Subjects will be instructed to use the nasal spray at a minimum of 8 doses each day and up to a maximum of 5 doses per hour and 40 doses in 24 hours starting on the TQD. Subjects will be instructed to use the nasal spray at a minimum of 8 doses each day and up to a maximum of 5 doses per hour and 40 doses in 24 hours starting on the TQD. . Nasal spray will be used from the TQD through the end of Week 20.
干预措施: Behavioral counseling (Behavioral)
Placebo nasal spray
Subjects will be instructed to use the nasal spray at a minimum of 8 doses each day and up to a maximum of 5 doses per hour and 40 doses in 24 hours starting on the TQD. Subjects will be instructed to use the nasal spray at a minimum of 8 doses each day and up to a maximum of 5 doses per hour and 40 doses in 24 hours starting on the TQD. Nasal spray will be used from the TQD through the end of Week 20.
干预措施: Nicotine Nasal Spray (Drug)
Placebo nasal spray
Subjects will be instructed to use the nasal spray at a minimum of 8 doses each day and up to a maximum of 5 doses per hour and 40 doses in 24 hours starting on the TQD. Subjects will be instructed to use the nasal spray at a minimum of 8 doses each day and up to a maximum of 5 doses per hour and 40 doses in 24 hours starting on the TQD. Nasal spray will be used from the TQD through the end of Week 20.
干预措施: Behavioral counseling (Behavioral)
结局指标
主要结局
The Number of Subjects Who Quit Smoking From Weeks 5 to 8
时间窗: 4 weeks
Quit rate is defined as the proportion of individuals who self report no tobacco use during weeks 5 through 8 confirmed by exhaled carbon monoxide (CO) less than 10 parts per million (ppm) during these 4 weeks.
次要结局
未报告次要终点