NCT04089982已完成4 期
Pilot Study on Varenicline in Light and Intermittent Smokers
适应症
干预措施
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 11
- 试验地点
- 1
- 主要终点
- Change in Self-Reported Craving Level Via Lab-Based Cue Reactivity
研究概览
简要总结
The goal of this study is to assess varenicline vs. placebo for its effect on decreasing cue reactivity in light and intermittent smokers.
详细描述
The study will consist of randomization to receive either varenicline or placebo over 6 weeks and include 5 study visits. Participants are offered an optional additional 6 weeks of active varenicline. Cue reactivity will be assessed in both a lab-based setting (viewing series of images and rating cravings) and in a real-world setting (text-based daily interaction).
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 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age 18 years or above
- •Daily smoker using 10 or less cigarettes per day but a minimum of at least 1 cigarettes per week or 4 cigs/month.
- •Must be able to make it through a 24-hour period without nicotine withdrawal symptoms (specifically does not have new onset of irritability, headaches, insomnia, or intense cravings).
- •Willing to quit smoking in the next 30 days
- •Is able to provide written informed consent (in English) to participate in the study and is able to read/understand the procedures and study requirements.
- •Is willing to voluntarily sign and date an informed consent form that is approved by an institutional review board before the conduct of any study procedure.
- •If female and of childbearing potential, is willing to use medically acceptable contraceptive measures for the duration of the study. Acceptable methods of contraception include (1) surgical sterilization (such as tubal ligation or hysterectomy, (2) approved hormonal contraceptives (such as birth control pills, patches, implants or injections), (3) barrier methods (such as condom or diaphragm) used with a spermicide, or (4) an intrauterine device (IUD). Contraceptive measures such as rhythm method or Plan B™, sold for emergency use after unprotected sex, are not acceptable methods for routine use.
- •Have access to a cell phone that can send and receive SMS text messages.
排除标准
- •Use of a smoking cessation medication (e.g. nicotine replacement, varenicline, bupropion) in last 30 days.
- •Current use of tobacco product other than cigarettes (e.g. e-cigarettes, smokeless tobacco) in the last 30 days
- •Answer > 0 on suicidality question of Patient Health Questionnaire (PHQ-9) Depression Scale
- •Active alcohol use disorder or hazardous drinking. This will be screened with the AUDIT-C, and positive scores (4 or greater for men and 3 or greater for women)54,55 will result in study clinician assessment and discretion.
- •Use of illicit drugs in the last month (marijuana, cocaine, opiates, benzodiazepines, and/or methamphetamine)
- •Severe symptomatic depression and or anxiety (study medical provider discretion)
- •Diagnosis of bipolar disorder, schizophrenia, PTSD and or adult ADHD (study medical provider discretion)
- •Chronic medical illness including diabetes with the use of insulin, Hemoglobin A1c > 7 (study medical provider discretion), heart disease diagnosed by angiogram, or COPD diagnosed by pulmonary function testing and requiring an oxygen supply
- •Specific medications (Appendix 1)
- •Abnormal finding on physical exam (study medical provider discretion)
- •Positive Urine Pregnancy Test (women of child bearing potential only; QuickVue Urine Pregnancy)56
- •Positive Urine Toxicology-5 Screen (methamphetamine, cocaine, opiates, benzodiazepines, THC)
- •Unstable hypertension (Blood pressure > 160/100)
- •Renal failure with active or pending hemodialysis
研究组 & 干预措施
Varenicline
Active Comparator
Varenicline BID
干预措施: Varenicline (Drug)
Placebo
Placebo Comparator
干预措施: Placebo oral tablet (Drug)
结局指标
主要结局
Change in Self-Reported Craving Level Via Lab-Based Cue Reactivity
时间窗: Baseline, Visit 4 (week 6)
Participants were asked to self-report craving level to smoke on a scale of 1-10 with 1 corresponding to no craving and 10 corresponding to intense craving. Self-reported craving level was requested following presentation of multiple images on a screen over a 20 minute period. Four types of images were presented - neutral affect, negative affect, smoking and social images.
次要结局
- Change in Self-Reported Craving Level Via Real-World Cue Reactivity(Baseline, Visit 4 (week 6))
- Changes in Smoking Abstinence(Screening visit, Visit 4 (week 6))
- Changes in Smoking(Screening visit, Visit 4 (week 6))
- Medication Adherence(Screening visit, Visit 4 (week 6))
- Medication Tolerance by Self-Reported Side Effects(Up to 12 weeks)
研究者
研究点 (1)
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