NCT00563563已完成2 期
An Open-Label Study Assessing the Safety and Efficacy of Naltrexone Sustained Release (SR) in Combination With Bupropion Sustained Release (SR) in Overweight and Obese, Nicotine-Dependent Subjects
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 30
- 试验地点
- 1
- 主要终点
- Assess rates of smoking cessation defined by continuous abstinence.
研究概览
简要总结
The purpose of this study is to determine whether a combination of naltrexone SR and bupropion SR is safe and effective in the treatment of nicotine-dependence in overweight and obese subjects.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
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
- •Female and male subjects must be 18 to 65 years of age;
- •Have body mass index (BMI) greater than or equal to 27 and less than or equal to 45kg/m2;
- •Have smoked an average of at least 10 cigarettes/day in the preceding year, with < 3 month total abstinence period;
- •Self-reported level of motivation to stop smoking ≥ 7, on a scale of 1-to-10;
- •At least moderately concerned about gaining weight after quitting smoking
- •Women of child-bearing potential, must be non-lactating and agree to use effective contraception throughout the study period and 30 days after discontinuation of study drug;
- •Able to comply with all required study procedures and schedule;
- •Able to speak and read English;
- •Willing and able to give written informed consent.
排除标准
- •Obesity of known endocrine origin
- •Serious medical condition
- •History of drug or alcohol abuse or dependence
- •Use of excluded concomitant medications
- •History of surgical or device (e.g. gastric banding) intervention for obesity;
- •History or predisposition to seizures
- •Pregnant or breast-feeding women or planning to become pregnant during the study period or within 30 days of discontinuing study drug;
- •Planned surgical procedure that can impact the conduct of the study;
- •Use of investigational drug, device or procedure within 30 days prior to Screening;
- •Participation in any previous clinical trial conducted by Orexigen Therapeutics;
- •Any condition which in the opinion of the investigator makes the subject unsuitable for inclusion in the study.
研究组 & 干预措施
NB32
Experimental
Naltrexone SR 32 mg/Bupropion SR 360 mg daily subjects will receive ancillary therapy including counseling on smoking cessation, diet and exercise.
干预措施: NB32 (Drug)
NB32
Experimental
Naltrexone SR 32 mg/Bupropion SR 360 mg daily subjects will receive ancillary therapy including counseling on smoking cessation, diet and exercise.
干预措施: Ancillary therapy (Behavioral)
结局指标
主要结局
Assess rates of smoking cessation defined by continuous abstinence.
时间窗: 12 weeks
次要结局
- To assess the percent change from baseline in total body weight during the entire study(Baseline to endpoint)
- To assess the rates of smoking cessation as measured by expired CO levels <10 ppm(12 and 24 weeks)
- To assess the change from baseline in tobacco use from baseline as measured by a tobacco use diary(Baseline to endpoint)
研究者
研究点 (1)
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