Pharmacogenetics, Emotional Reactivity and Smoking
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 646
- 试验地点
- 1
- 主要终点
- Emotional Reactivity By Pharmacotherapy
研究概览
简要总结
The goals of this placebo-controlled randomized clinical trial were to evaluate the differences in emotional reactivity (peak startle response to affective stimuli) during a cessation attempt among smokers treated with bupropion, varenicline, or placebo, and to determine if these differences were moderated by genotype.
详细描述
Bupropion and Varenicline are smoking cessation aids that may help people to quit smoking.
During the orientation visit, the study will be explained to you and you will be given an opportunity to ask, and have answered, any questions you may have. You will also be asked to give a buccal (cheek cell) sample for genetic analysis. This session will last about 1.5 hours.
During the screening visit, you will be asked questions about your health, medication use, smoking history, and tobacco use. You will be asked about any current or past feelings of depression. Also, a small blood sample will be drawn (about 2 tablespoons) from your upper arm for a liver and kidney function test and a saliva sample will be collected to measure whether you are smoking. Women who are able to have children must have a negative urine pregnancy test. This session will last about 2.5 hours.
If you are eligible to take part in the study, you will be randomly assigned (as in the toss of a coin) to one of three treatment groups. Participants in the first group will receive Bupropion. Participants in the second group will receive Varenicline. Participants in the third group will receive a placebo. A placebo is a substance that looks like the study drug but which has no active ingredients. You will have an equal chance of being assigned to the Bupropion, Varenicline, or placebo treatment group. Neither you nor your counselor will know to which group you were assigned.
All participants will take study pills (either Bupropion, Varenicline, or placebo) by mouth for 12 weeks. The dose of study medication may or may not change during the study. You will be responsible for returning any unused, used, or partly used study medication bottles to a study staff member.
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
- Double (Participant, 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
- 否
入选标准
- •Age: 18-65 years old
- •Smoking: >/= 5 cigarettes per day within the 2 months preceding the screening visit and expired CO greater than or equal to 6 ppm.
- •Able to follow verbal and written instructions in English and complete all aspects of the study
- •Have an address and home telephone number where they may be reached
- •Provide informed consent and agree to all assessments and study procedures
- •Be the only participant in their household
排除标准
- •Within the month immediately preceding the screening visit; use of any form of tobacco product other than cigarettes on 3 or more days within a week only if the individual refuses to refrain from non-cigarette tobacco use during the course of this study
- •Within the month immediately preceding the screening visit; use of marijuana in any form on 3 or more days within a week
- •Within the two weeks immediately preceding the screening visit, involvement on more than 3 days in any formal smoking cessation activities
- •Current visual or auditory problems that in the opinion of the investigator would interfere with the completion of study assessments
- •Treatment on a continuous basis within 2 weeks before the screening visit: any contraindicated medication for Varenicline or Bupropion.
- •Uncontrolled hypertension or other major contraindications for Bupropion or Varenicline.
- •Severe renal impairment (CR Clearance <30 ml/min/1.73 m2).
- •Laboratory evaluations outside normal limits and of potential clinical significance in the opinion of the investigator
- •Meet current criteria for psychiatric disorders or substance abuse as assessed by the MINI for items A, B, D, I, J, K, L, M and N, including a past manic or hypomanic episode as well as a lifetime psychotic disorder.
- •Subject rated as moderate to high on suicidality as assessed by the MINI.
- •Psychiatric hospitalization within 1 year of screening date.
- •A positive urine pregnancy test during the screening period. Women who are two years post menopausal, one year post-tubal ligation, or who have had a partial or full hysterectomy will not be subject to a urine pregnancy test.
- •Pregnant, breast-feeding, or of childbearing potential who is not protected by a medically acceptable, effective method of birth control while enrolled in the study
- •Use of Varenicline or Bupropion within two weeks before the screening visit.
- •History of hypersensitivity or allergic reaction to Varenicline, tricyclic antidepressant, Bupropion (Wellbutrin, Zyban) or similar chemical classes or any component of these formulations.
- •Subject considered by the investigator as unsuitable candidate for receipt of an investigational drug, or unstable to be followed up throughout the entire duration of the study.
研究组 & 干预措施
Bupropion
Bupropion starting dose 150 mg by mouth daily (150 mg every morning for three days; 150 mg twice a day thereafter).
干预措施: Bupropion (Drug)
Bupropion
Bupropion starting dose 150 mg by mouth daily (150 mg every morning for three days; 150 mg twice a day thereafter).
干预措施: Smoking Cessation Counseling (Behavioral)
Varenicline
Varenicline starting dose 0.5 mg by mouth daily (0.5 mg every morning for days 1 - 3, then 0.5 mg twice a day for days 4 - 7, then 1 mg twice a day thereafter).
干预措施: Varenicline (Drug)
Varenicline
Varenicline starting dose 0.5 mg by mouth daily (0.5 mg every morning for days 1 - 3, then 0.5 mg twice a day for days 4 - 7, then 1 mg twice a day thereafter).
干预措施: Smoking Cessation Counseling (Behavioral)
Placebo
Placebo by mouth for 12 weeks.
干预措施: Placebo (Drug)
Placebo
Placebo by mouth for 12 weeks.
干预措施: Smoking Cessation Counseling (Behavioral)
结局指标
主要结局
Emotional Reactivity By Pharmacotherapy
时间窗: Baseline to 1 month
Emotional reactivity measured by the peak eye blink electromyography (EMG) of the orbicularis oculi (ORB) muscle responses to acoustic startle probe delivered during the presentation of emotionally valent stimuli (pleasant, unpleasant, neutral, and smoking-related pictures). A single value was estimated by averaging within the specific time interval.
Emotional Reactivity By Pharmacotherapy Moderated by DRD2 A1 Allele
时间窗: Baseline to 1 month
The emotional reactivity (ORB EMG) of smokers during cessation will be moderated by genotype. A single value was estimated by averaging within the specific time interval. During a quit attempt, smokers were evaluated on how they react to smoking related cues. An interaction term was then formed by the reactivity to smoking stimulus and genotype.
次要结局
- Smoking Abstinence at 3 Months(Baseline to 3 months)
- Smoking Abstinence at 3 Months by DRD2 A1 Allele(Baseline to 3 Month)
- Smoking Abstinence at 6 Months(Abstinence at 6 Months ( the effects shown are the increase/decrease in probability of abstinence for 1 unit increase in the predictor))
- Abstinence at 6 Months by DRD2 A1 Allele(Baseline to 6 Month ( the effects shown are the increase/decrease in probability of abstinence for 1 unit increase in the predictor))
- Symptoms of Nicotine Withdrawal Using the Wisconsin Smoking Withdrawal Scale (WSWS)(Baseline to 8 months)
- Symptoms of Nicotine Withdrawal and Negative Affect Using Positive and Negative Affect Scale (PANAS)(Baseline to 8 months)
- Symptoms of Depression Using the Center for Epidemiologic Studies Depression Scale (CES-D)(Baseline to 8 months)
- Measures of Smoking Satisfaction and Psychological Reward Using the Modified Cigarette Evaluation Questionnaire (mCEQ) Subscales(Baseline to 8 months)
- Heart Rate Response(Baseline to 1 month)
- Skin Conductance Response(Baseline to 1 month)