NCT02393547已完成1 期
Lorcaserin for Preventing Weight Gain Among Smokers Receiving Varenicline: A Pilot Study
适应症
干预措施
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- Mayo Clinic
- 入组人数
- 20
- 试验地点
- 1
- 主要终点
- Post Cessation Weight Change
研究概览
简要总结
This will be an open label clinical trial with all subjects receiving both lorcaserin and varenicline with a primary aim of reducing post cessation weight gain.
详细描述
This will be an open label clinical trial with all subjects receiving both lorcaserin and varenicline. The investigators will obtain preliminary data on the efficacy of lorcaserin (10 mg twice daily) for 12 weeks in 20 adult weight-concerned cigarette smokers with a BMI of 27 to 40 simultaneously receiving 12 weeks of open-label varenicline and a behavioral intervention to assist with stopping smoking. Secondary aims will be weight, waist circumference, and smoking cessation.
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
- 是
入选标准
- •≥18 years and ≤65 years of age;
- •smoked ≥10 cigarettes/day for the past 6 months;
- •BMI of 27-40 kg/m2;
- •resides within the Olmsted County area;
- •motivated to stop smoking;
- •weight concerned as shown with the Weight Concern Scale;
- •able to participate fully in all aspects of the study;
- •understood and signed the study informed consent.
排除标准
- •current nonspecific suicidal thoughts or a lifetime history of a suicidal attempt (defined by the Columbia-Suicide Severity Rating Scale [C-SSRS] as a "potentially self-injurious act committed with at least some wish to die, as a result of act.");
- •current moderate or severe depression as assessed by a score of ≥16 on the Center for Epidemiologic Studies-Depression (CES-D);
- •a lifetime history of bipolar disorder or schizophrenia;
- •use of anti-psychotic medication within the past 30 days;
- •use of weight-loss medications within the past 30 days or current participation in a program specifically designed to help with weight loss;
- •weight fluctuations of 20 pounds or more in the past 6 months (self-report);
- •use of any treatments for tobacco dependence within the past 30 days;
- •use of an investigational drug within the past 30 days;
- •recent history (past 3 months) of abuse of or dependence on a substance other than tobacco;
- •current use of benzodiazepines, narcotics, anti-epileptics, or other medications known to interact with lorcaserin (see human subjects section);
- •current use of triptans, monoamine oxidase inhibitors, selective serotonin reuptake inhibitors (SSRIs), selective serotonin-norepinephrine reuptake inhibitors (SNRIs), dextromethorphan, tricyclic antidepressants (TCAs), bupropion, lithium, tramadol, tryptophan, and St. John's Wort, or any other medication known to involve the serotonergic neurotransmitter system (see human subjects section);
- •uncontrolled hypertension (systolic >160 mm Hg and/or diastolic >100 mm Hg) documented on 2 separate occasions;
- •clinically significant acute or chronic progressive or unstable neurologic, hepatic, renal, cardiovascular, respiratory, or metabolic disease;
- •current use of medications known to interact with varenicline or lorcaserin;
- •another household member or relative participating in the study;
- •Known Diabetes;
- •a known allergy to varenicline or lorcaserin;
- •have taken antibiotics within the past 3 months.
- •Women who are pregnant or lactating, or who are of childbearing potential and are likely to become pregnant during the medication phase but are not willing to use a reliable form of contraception, will also be excluded. Reliable forms of contraception include oral contraception, diaphragm or condom (with spermicide), injections, intrauterine device, surgical sterilization, and abstinence.
研究组 & 干预措施
Varenicline + Lorcaserin
Experimental
Open label all subjects receive both Varenicline and Lorcaserin
干预措施: Varenicline (Drug)
Varenicline + Lorcaserin
Experimental
Open label all subjects receive both Varenicline and Lorcaserin
干预措施: Lorcaserin (Drug)
结局指标
主要结局
Post Cessation Weight Change
时间窗: 12 weeks
change in weight from baseline to week 12
次要结局
- Waist Circumference(12 Weeks)
- BMI(12 weeks)
- Smoking Abstinence Rates(12 weeks)
研究者
Ryan T. Hurt, M.D., Ph.D.
Associate Professor
Mayo Clinic
研究点 (1)
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