Pregabalin Given to Tobacco Users to Study Addiction
试验速览
- 阶段
- 早期 1 期
- 状态
- 已完成
- 入组人数
- 24
- 试验地点
- 1
- 主要终点
- We believe this medication will help people to stop smoking
研究概览
简要总结
The goal of this study is to examine the effects of a GABA (gamma amino butyric acid)-enhancing medication, pregabalin (300 mg/day), on smoking behavior, tobacco withdrawal and cigarette craving in smokers. We hypothesize that in smokers, pregabalin at 300 mg/day, will be more effective than placebo in decreasing smoking behavior and attenuating tobacco withdrawal and cigarette craving.
详细描述
A total of 40 smokers will be randomly assigned to a sequence of treatment conditions: 300 mg/day pregabalin or placebo treatment. Each treatment condition will last 4 days, separated by 3 to 15 days of washout period. Smokers will have twice daily outpatient visits during the first 3 days and a test session on day 4. In each treatment period, smokers will abstain from smoking for 2.5 days, starting at 10 pm on Day 1 until the test session on Day 4. During the test sessions, measures of smoking behavior and tobacco withdrawal will be obtained.
Smoking is an important public health problem costing over 430,000 lives a year in this county alone. The first line-treatments, Nicotine Replacement Treatments (NRT) or bupropion, compared to placebo, approximately double the long-term success rate for smoking cessation. Given that there remains 46 million smokers in this country and over 70 percent of them interested in quitting smoking, development of new treatments for smoking cessation will have great public health implications.
Currently this protocol is complete with 24 completers. This study has been published. (April 2011)
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Treatment
- 盲法
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 18 Years 至 55 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Female and male smokers, aged 18 to 55 years
- •History of smoking daily for the past 12 months
- •at least 15 cigarettes daily
- •In good health as verified by medical history
- •screening examination
- •screening laboratory tests
- •not pregnant as determined by pregnancy screening, nor breast feeding
- •using acceptable birth control methods.
排除标准
- •History of pregabalin allergy
- •Use of psychotropic medication antidepressants, antipsychotics DSM-IV axis I diagnosis (schizophrenia, bipolar disorder, major depression
- •Dependence or abuse of alcohol or any other illicit or prescription drugs
- •current use of any other tobacco products, including smokeless tobacco
- •history of seizures
- •Inability to fulfill all scheduled visits and examination procedures
研究组 & 干预措施
A
pregabalin 300mg/day given in conjunction with smoking cigarettes.
干预措施: pregabalin (Drug)
A
pregabalin 300mg/day given in conjunction with smoking cigarettes.
干预措施: cigarettes (Other)
2
cigarettes given in conjunction with pregabalin
干预措施: pregabalin (Drug)
2
cigarettes given in conjunction with pregabalin
干预措施: cigarettes (Other)
结局指标
主要结局
We believe this medication will help people to stop smoking
时间窗: 2 years
次要结局
未报告次要终点