NCT00622752已完成2 期
A Double-Blind, Randomized, Placebo- and NRT -Controlled Phase II Study to Assess the Effects of EVT 302 Alone and in Combination With NRT on Craving and Withdrawal in Healthy Male Smokers Deprived of Cigarettes
Evotec Neurosciences GmbH1 个研究点 分布在 1 个国家目标入组 90 人开始时间: 2008年2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
- 已完成
- 发起方
- 入组人数
- 90
- 试验地点
- 1
- 主要终点
- Reduction in Craving and withdrawal
研究概览
简要总结
This randomised, placebo-controlled study is designed to explore the effects of EVT 302 both with and without concomitant nicotine replacement therapy (NRT) on craving and withdrawal in smokers after short term deprivation of cigarettes.
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
- Triple (Participant, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 55 Years（Adult）
- 性别
- Male
- 接受健康志愿者
- 否
入选标准
- •Male subjects between 18 and 55 years of age, inclusive
- •BMI between 18 and 30, minimum weight of 50 kg
- •Negative urine drug & alcohol screen
- •Able to comply with tyramine-restricted diet
- •Smoking of ≥17 and ≤34 cigarettes per day for the past year and have not tried to quit smoking in the 3 months prior to screening
- •Subjects are willing and able to quit for about 12 hours in each of three subsequent study periods
- •Previous experience of craving following smoking cessation
- •Breath CO between 15 ppm and 20 ppm and cotinine in saliva and plasma at least 250 ng/mL at screening
- •Liver function test results not above 1.5 times the upper normal limit (UNL) at screening visit and at re-assessment during the study.
排除标准
- •Participation in another clinical study within 60 days of screening
- •Evidence of active significant psychiatric or neurological disease or dependency other than cigarettes
- •Are known to have or are a carrier of the hepatitis B surface antigen (HBsAg), hepatitis C virus (HCV) antibody, has a positive result to the human immunodeficiency virus-1 and/or 2 (HIV-1 and/or HIV-2) antibodies
- •Known hypersensitivity to MAO inhibitors or any substance that is contained in the study formulations
- •Known allergy to plasters or NRT patches
- •Previous participation in another study with EVT 302
- •Currently receiving treatment for smoking cessation
- •Current use of tobacco products other than cigarettes
- •Require treatment with any medication
- •Subject with a clinically relevant abnormal 12-lead ECG recording or QTcB/F >430 ms
- •Use of a prescription medicine within 14 days or 5 half-lives, whichever is the longer, of the start of dosing, or use of an over-the-counter medication during the 7 days before the study, including herbal remedies, but excluding paracetamol and vitamin supplements (provided intake does not exceed the daily recommended allowance)
- •Subjects must not be planning to father a child or donate sperm, during the study and 3 months after the end of the study. Acceptable methods of contraception comprise barrier contraception and a medically accepted contraceptive method for the female partner (intra-uterine device with spermicide, hormonal contraceptive since at least 2 month)
- •Daily consumption of more than 5 cups of tea or coffee, or more than 1.0 litre of xanthine-containing drinks
- •Recent myocardial infarction, unstable or worsening angina pectoris, prince metal angina, severe arrhythmias, recent stroke.
- •Creatinine clearance (CLR) calculated according to the formula by Modification of Diet in Renal Disease (MDRD) of <80 mL/min
研究组 & 干预措施
1
Experimental
EVT 302, 10 mg
干预措施: EVT 302, 10 mg (Drug)
2
Experimental
EVT 302, 10 mg + NRT patch, 21 mg
干预措施: EVT 302, 10 mg (Drug)
2
Experimental
EVT 302, 10 mg + NRT patch, 21 mg
干预措施: Nicotine replacement therapy (NRT) (Drug)
3
Experimental
NRT patch, 21 mg
干预措施: Nicotine replacement therapy (NRT) (Drug)
4
Placebo Comparator
Placebo to match EVT 302 and placebo patch to match NRT patch
干预措施: placebo (Drug)
4
Placebo Comparator
Placebo to match EVT 302 and placebo patch to match NRT patch
干预措施: NRT placebo (Device)
结局指标
主要结局
Reduction in Craving and withdrawal
时间窗: Within 12 hours of the last cigarette
次要结局
- Salivary cotinine levels(12 hours post last cigarette)
- CogState Cognitive test Battery(12 hours post last cigarette)
- Breath carbon monoxide levels(12 hours post last cigarette)
- Assessment of adverse events(Up to 7 days post dose)
- Clinical safety lab tests(Up to 7 days post dose)
研究者
研究点 (1)
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