Evaluation of Moclobemide, a Reversible MAO-A Inhibitor, as an Adjunct to Nicotine Replacement Therapy in Female Smokers
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 76
- 试验地点
- 2
- 主要终点
- Continuous Four-week Abstinence From Smoking
研究概览
简要总结
The proposed study will assess the efficacy of moclobemide, a selective, reversible MAO-A inhibitor, in facilitating smoking cessation in treatment-seeking female smokers. This rationale is based on several findings from previous work: 1) cigarette smoke contains constituents that inhibit both forms of the enzyme monoamine oxidase (MAO-A and MAO-B); 2) that severity of depression symptoms after smoking abstinence is correlated with the level of MAO-A inhibition previously obtained from smoking; 3) moclobemide, an MAO-A inhibitor was found efficacious in a smoking cessation treatment trial (Berlin et al., 1995); and 4) women show a greater association between smoking and depression than men and women smokers in our previous trials report smoking to alleviate symptoms of depression to a greater extent than men.
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
- Female
- 接受健康志愿者
- 否
入选标准
- •Have no known serious medical conditions;
- •Are 18-65 years old;
- •Smoke an average of at least 20 cigarettes per day;
- •Have smoked at least one cumulative year;
- •Have a Fagerstrom Test for Nicotine Dependence score of at least 5;
- •Have an expired air carbon monoxide (CO) reading of at least 10ppm;
- •Able to read and understand English;
- •Express a desire to quit smoking in the next thirty days.
- •Potential subjects must agree to avoid the following during their participation in this study:
- •excessive alcohol consumption;
- •use of other antidepressants;
- •general anesthesia;
- •participation in any other nicotine-related modification strategy outside of this protocol;
- •use of tobacco products other than cigarettes, including pipe tobacco, cigars, e-cigarettes, snuff, and chewing tobacco;
- •use of experimental (investigational) drugs or devices;
- •use of illegal drugs;
- •cimetidine;
- •Tyramine rich foods;
- •use of opiate medications.
排除标准
- •Hypertension;
- •Hypotension with symptoms;
- •Coronary heart disease;
- •Lifetime history of heart attack;
- •Cardiac rhythm disorder;
- •Chest pains;
- •Cardiac (heart) disorder;
- •Active skin disorder;
- •Liver or kidney disorder;
- •Gastrointestinal problems or disease other than gastroesophageal reflux or heartburn;
- •Active ulcers in the past 30 days;
- •Currently Symptomatic lung disorder/disease;
- •Brain abnormality;
- •Migraine headaches that occur more frequently than once per week;
- •Recent, unexplained fainting spells;
- •Problems giving blood samples;
- •Diabetes (unless controlled by diet and exercise alone);
- •Current cancer or treatment for cancer in the past six;
- •Other major medical condition;
- •Current psychiatric disease;
- •Suicidal ideation (within the past 10 years) or lifetime occurrence of attempted suicide;
- •Current depression;
- •Bulimia or anorexia;
- •Use (within the past 45 days) of psychiatric medications including antidepressants and anti-psychotics;
- •Use (within the past 30 days) of:
- •Illegal drugs (or if the urine drug screen is positive for tetrahydrocannabinol (THC), Cocaine, Amphetamine, Opiates, Methamphetamines, phencyclidine (PCP), Benzodiazepines, or Barbiturates),
- •Experimental (investigational) drugs;
- •Any medications that are known to affect smoking cessation (e.g. clonidine);
- •Smokeless tobacco (chewing tobacco, snuff), pipes or e-cigarettes;
- •Wellbutrin, bupropion, Zyban, Chantix, nicotine replacement therapy or any other smoking cessation aid.
- •Use of opiate medications for pain or sleep (non-opiate medication for pain or sleep will be allowed) within the past 14 days;
- •Smokes more than one cigar a month.
- •Alcohol abuse;
- •Significant adverse reaction to nicotine patches, in the past.
- •Known hypersensitivity to moclobemide or other MAO-A inhibitors.
- •Current participation or recent participation (in the past 30 days) in another smoking study at our center or another research facility.
- •Current participation or recent participation (in the past six months) in another medical research study.
研究组 & 干预措施
Nicotine Patch+Moclobemide
After 1 week of pre-cessation nicotine patch treatment (21 mg/24 h patches), participants will receive moclobemide (400 mg/day in 2 divided doses) for 11 weeks, ending 10 weeks after the target quit date. Nicotine patch treatment will continue at 21 mg/24 h for an additional week prior to the quit date, and then for 6 weeks after the quit date, followed by 14 mg/24 h for 2 weeks and 7 mg/24 h for 2 weeks. All treatment will terminate 10 weeks after the quit date.
干预措施: Nicotine Patch (Drug)
Nicotine Patch+Moclobemide
After 1 week of pre-cessation nicotine patch treatment (21 mg/24 h patches), participants will receive moclobemide (400 mg/day in 2 divided doses) for 11 weeks, ending 10 weeks after the target quit date. Nicotine patch treatment will continue at 21 mg/24 h for an additional week prior to the quit date, and then for 6 weeks after the quit date, followed by 14 mg/24 h for 2 weeks and 7 mg/24 h for 2 weeks. All treatment will terminate 10 weeks after the quit date.
干预措施: Moclobemide (Drug)
结局指标
主要结局
Continuous Four-week Abstinence From Smoking
时间窗: Weeks 6-10 post quit day
Number of participants who reported continuous four-week abstinence from smoking (weeks 6-10 post target quit date), confirmed by expired air carbon monoxide (CO).
次要结局
- Point Abstinence From Smoking at Six Months Post Quit(7 day point abstinence from smoking at six months post quit)
- Percentage of Change in Smoking Withdrawal Symptoms(Quit day and 1 week, 3 weeks, 6 weeks, 10 weeks and 6 months post quit day)
- Continuous Ten Week Abstinence From Smoking(10 weeks post quit day)
- Percentage of Change in Expired Air Carbon Monoxide (CO) During the First Week of Nicotine Patch Treatment.(Baseline and 1 week)
研究者
Jed E. Rose
Professor, Department of Psychiatry and Behavioral Sciences
Duke University