NCT00827281撤回2 期
D-Cycloserine Enhancement of Exposure-Based CBT for Smoking Cessation
Boston University Charles River Campus1 个研究点 分布在 1 个国家开始时间: 2008年8月最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 撤回
- 发起方
- 试验地点
- 1
- 主要终点
- Cotinine levels in saliva
研究概览
简要总结
This study examines whether isolated doses of D-cycloserine enhance the efficacy of CBT for smoking cessation.
详细描述
In comparison to placebo-augmented cognitive behavioral therapy (CBT), D-cycloserine-augmented CBT will lead to a greater reduction in both short-and long-term point prevalence abstinence as well as time to first smoking lapse and time to smoking relapse.
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 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Be a regular smoker for at least one year
- •Currently smoke an average of at least 10 cigarettes per day
- •Report a motivation to quit smoking in the next month of at least 5 on a 10 point scale
- •Score 20 or greater on the 16-item Anxiety Sensitivity Index (Schmidt & Joiner, 2002).
排除标准
- •Current diagnosis of a psychotic, eating, developmental or bipolar disorder (as determined by the SCID)
- •Current anxiety or mood disorder rated moderate or greater (i.e., CGI score of 4 or greater for an anxiety or depressive disorder or any current or recent-1 year--suicidal ideation)
- •Psychoactive substance abuse or dependence (excluding nicotine dependence) within the past 6 months
- •Current use of isoniazid psychotropic medication
- •A history of significant medical condition, such as cardiovascular, neurologic, gastrointestinal, pregnancy and/or breast feeding, history of seizure (other than febrile seizures in childhood) or other systemic illness and/or be deemed as currently unhealthy in the context of a complete physical examination
- •Limited mental competency and the inability to give informed, voluntary, written consent to participate,
- •Current use of any pharmacotherapy or psychotherapy for smoking cessation not provided by the researchers during the quit attempt,
- •Concurrent psychotherapy initiated within three months of baseline, or ongoing psychotherapy of any duration directed specifically toward treatment of anxiety or mood disorder other than general supportive therapy initiated at least 3 months prior to the study
- •Use of other tobacco products
- •Planning on moving (outside of the immediate area) in the next six months
- •Insufficient command of the English language (i.e., they cannot carry on a conversation with an interviewer in the English language or read associated text).
研究组 & 干预措施
1
Experimental
DCS-augmented CBT for smoking cessation
干预措施: D-cycloserine (Drug)
2
Placebo Comparator
Placebo-augmented CBT for smoking cessation
干预措施: Placebo (Drug)
结局指标
主要结局
Cotinine levels in saliva
时间窗: Baseline, Weeks 21 & 29
Carbon monoxide analysis
时间窗: Baseline, Weeks 4, 5, 6, 7, 8, 9, 13, 21, & 29
次要结局
- Anxiety Sensitivity Index(Baseline, Weeks 5, 6, 7, 8, 9, 13, 21 & 29)
- Minnesota Withdrawal Scale(Each visit)
- Mood & Anxiety Symptom Questionnaire(Baseline, Weeks 1, 2, 3, 4, 5, 6, 7, & 8)
- Smoking Cessation Self-Efficacy(Baseline, Weeks 3, 4, 5, 6, 7, 8, 9, 13, 21 & 29)
研究者
Michael Otto
Ph.D.
Boston University Charles River Campus
研究点 (1)
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