Validation of a Novel Paradigm for Screening Medications for Nicotine Dependence
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 62
- 试验地点
- 1
- 主要终点
- Days of abstinence following the programmed lapse
研究概览
简要总结
The goal of the proposed study is to validate an experimental paradigm to assess medication effects on smoking relapse following a brief (3-day) monitored period of smoking abstinence and a programmed cigarette lapse.
详细描述
The proposed human experiment will test the validity of a novel paradigm that may provide a method for distinguishing compounds that are likely to have efficacy from those that are not, before they are tested in more costly large-scale clinical trials. Specifically, in a within-subject (cross-over) behavioral pharmacology investigation of 60 smokers, we will test the effects of varenicline versus placebo on smoking behavior in the natural environment following a 3-day period of monitored abstinence and a programmed cigarette lapse. A positive signal for varenicline effects in this study would provide support for the sensitivity of the paradigm. In addition, following completion of all assessments, participants will be followed in a 13-week open-label varenicline smoking cessation trial to determine whether response to varenicline in the laboratory study predicts clinical response in the open-label trial.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Screening
- 盲法
- Triple (Participant, Care Provider, Investigator)
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
- •Eligible participants will be 68 (34 male and 34 female) smokers aged 18-65, who smoke ≥ 10 cigarettes per day, provide a baseline CO reading ≥ 10 ppm and who plan to live in the area for the next 6-months.
排除标准
- •Smoking Behavior
- •Use of chewing tobacco or snuff
- •Current enrollment or plans to enroll in another smoking cessation program in the next 5 months
- •Plan to use other nicotine substitutes or smoking cessation treatments in the next 5 months
- •Provide a baseline CO reading < 10 ppm
- •Alcohol/Drug Exclusion Criteria
- •History of substance abuse and/or currently receiving treatment for substance abuse (e.g., alcohol, opioids, cocaine, marijuana, or stimulants)
- •Current alcohol consumption that exceeds >25 standard drinks/week
- •Medication Exclusion Criteria
- •Current use or recent discontinuation (within last 14-days) of the following medications:
- •Any form of smoking cessation medication (zyban, wellbutrin, wellbutrin SR, Chantix, NRT)
- •Any form of anti-psychotic medications that includes:
- •antipsychotics,
- •atypical antipsychotics,
- •mood-stabilizers,
- •anti-depressants (tricyclics, SSRI's, MAOI's),
- •anti-panic agents,
- •anti-obsessive agents,
- •anti-anxiety agents, and
- •stimulants (e.g., Provigil, Ritalin).
- •Medication for chronic pain
- •Anti-coagulants
- •Any heart medications
- •Daily medication for asthma
- •Medical Exclusion Criteria
- •Women who are pregnant, planning a pregnancy, or lactating.
- •History or current diagnosis of psychosis, major depression or bipolar disorder, schizophrenia, or any Axis 1 disorder as identified by the SCID.
- •Serious or unstable disease within the past 6 months (e.g., cancer [except melanoma], heart disease, HIV).
- •History of epilepsy or a seizure disorder.
- •History or current diagnosis (last 6-months) of abnormal rhythms and/or tachycardia (>100 beats/minute); history or current diagnosis of COPD, cardiovascular disease (stroke, angina, coronary heart disease), heart attack in the last 6 months, uncontrolled hypertension (SBP>150 or DBP>90)
- •History of Kidney and/or liver failure (including transplant).
- •Wears a device to aid in hearing (hearing aid, cochlear implant, etc.).
- •Hearing threshold < 40 dB SPL at 1000 Hz.
- •Color blindness.
- •General Exclusion
- •Any medical condition or concomitant medication that could compromise participant safety or treatment, as determined by the Principal Investigator and/or Study Physician.
- •Inability to provide informed consent or complete any of the study tasks as determined by the Principal Investigator and/or Study Physician.
- •Any physical or visual impairment that may prevent the individual from using a computer keyboard or completing any study tasks.
研究组 & 干预措施
Varenicline
Participants will complete a 21-day study phase that will include a 10-day drug run-up and monitoring phase (days 1-10), a 3-day abstinence phase (days 11-13), and a programmed lapse (day 14) followed by a 7-day observation phase in which participants are asked to remain abstinent and will receive modest monetary reinforcement for doing so (days 15-21).
干预措施: Varenicline (Drug)
Placebo
Participants will complete a 21-day study phase that will include a 10-day drug run-up and monitoring phase (days 1-10), a 3-day abstinence phase (days 11-13), and a programmed lapse (day 14) followed by a 7-day observation phase in which participants are asked to remain abstinent and will receive modest monetary reinforcement for doing so (days 15-21).
干预措施: Placebo (Drug)
结局指标
主要结局
Days of abstinence following the programmed lapse
时间窗: 7 days
次要结局
未报告次要终点