Testing a Full Substitution Therapy Approach As Treatment of Tobacco Dependence
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 入组人数
- 40
- 试验地点
- 1
- 主要终点
- Seven-day point prevalence smoking abstinence at end of trial (abstinence based on self-reported smoking abstinence verified by CO levels < 10 ppm)
研究概览
简要总结
This study will test a new medication strategy designed to help smokers quit. It will combine selegiline, a drug currently approved and available for the treatment of Parkinson's disease, with a nicotine skin patch. Forty nicotine-dependent smokers will enrolled in this study. Twenty will receive placebo (inactive pill) plus nicotine patch, and twenty will receive selegiline plus nicotine patch. Once enrolled in the study, subjects will visit the Nicotine Dependence Clinic at CAMH on a weekly basis for assessment of smoking behavior, a brief health check, collection of breath and urine samples (necessary to drug levels and nicotine levels), and receive brief individual counseling designed to help them stop smoking. The medication phase of this study lasts 9 weeks. A follow-up visit will be conducted six months after trial completion. At that point, health and behavioral measures will be re-assessed.
详细描述
This pilot study utilizes a double-blind, two-armed design to evaluate the efficacy of combining oral selegiline with transdermal nicotine patch for smoking cessation in 40 nicotine-dependent smokers. After successful completion of 3 screening visits (to ensure medical and psychiatric eligibility criteria are met), subjects will be randomized into one of two experimental groups:
- selegiline (10 mg/day) + NRT (21 mg/24 hr)
- matching placebo + NRT (21 mg/24 hr)
Randomization will be performed through the use a random number list to generate 50% selegiline/50% placebo and also 50% male/50% female within each of those treatment groups.
Participants will begin selegiline (or placebo) once a day during Week 1, and dose will be graduated to full study dosage (10 mg/day) by adding an evening intake (a.m. and p.m. dosing) for Weeks 2-8. Day 15 of the trial represents target quit day and the transdermal nicotine patch (21 mg/24hr) will be applied at this time. Patches will be worn in conjunction with study medication for Weeks 3-8, after which the patch will be removed and study medication tapered throughout Week 9.
Subjects will present weekly to the Nicotine Dependence Clinic where they will provide breath, urine and blood samples as required, receive brief smoking cessation counseling and complete questionnaires regarding their smoking behavior and psychological state. A post-trial physical will be conducted upon completion of Week 9. Monthly follow-up phone interviews will be conducted for 5 months and subjects will be re-assessed in the NDC for a 6-month follow-up.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Meet DSM-IV criteria for nicotine dependence with FTND score >
- •Smoke at least 15 cigarettes (3/4 pack) daily (averaged over 1 week, in the past 1 month).
- •At the time of initial evaluation, are motivated to quit smoking in the next 30 days.
- •Have made at least one unsuccessful attempt to quit smoking in the past year.
- •At baseline, have expired breath CO level >
- •Are between ages 18-70 years old.
- •Weigh at least 100 lbs (45.5 kg, selegiline dose < 0.22 mg/kg).
- •No previous use of nicotine replacement products in the one month prior to randomization.
- •Have the capacity to give informed consent, and are English-speaking.
排除标准
- •Have present or past diagnoses of schizophrenia, bipolar disorder, PTSD, BPD or major depressive illness.
- •Have abused alcohol or other drugs of abuse (cocaine, opiates, benzodiazepines, etc) in 6 months prior to randomization into the trial (based on clinical evaluation including self-report, and confirmed by positive urine).
- •Demonstrate serious medical conditions (i.e. abnormal liver function [as evidenced by AST, ALT or bilirubin values 2x ULN], unstable cardiovascular disease, significant blood abnormalities).
- •Exhibit or have history of clinical hypertension.
- •Exhibit active peptic ulcer disease.
- •Are pregnant, are trying to become pregnant, or are currently breastfeeding.
- •Are on current medication regimes that include antidepressants, or sympathomimetic agents, or meperidine and other meperidine-opioids which may have interactions with selegiline.
- •Known hypersensitivity to selegiline or NRT.
- •Are from the same household as another study participant.
研究组 & 干预措施
1
干预措施: Selegiline + nicotine replacement therapy (Drug)
2
干预措施: placebo + nicotine replacement therapy (Drug)
结局指标
主要结局
Seven-day point prevalence smoking abstinence at end of trial (abstinence based on self-reported smoking abstinence verified by CO levels < 10 ppm)
时间窗: 9 weeks
次要结局
- Last four weeks of Trial Continuous smoking abstinence rates (verified by CO < 10 ppm)(4 weeks)
- Seven-day point prevalence smoking abstinence(end of treatment, six-month follow-up)
- Treatment retention (based on survival analysis and number of weeks a subject completes in the trial)(upon completion)
- Time line follow back for cigarettes smoked, alcohol and caffeinated beverage use(Weeks 1-8; six-month follow-up)
- Tobacco craving as assessed by Tiffany scale for smoking urges(Weeks 1, 4 and 8; 6-month follow-up)
- DSM-IV nicotine withdrawal symptom checklist(Weeks 1, 4 and 8; 6-month follow-up)
研究者
Bernard Le Foll
MD, PhD, CCFP
Centre for Addiction and Mental Health