The Effects of Behavioral Counseling Plus Nicotine Replacement Therapy (NRT) or Varenicline on Smoking Cessation Among Smokers High and Low in Intrinsic Reward Sensitivity
试验速览
- 阶段
- 4 期
- 状态
- 进行中（未招募）
- 入组人数
- 204
- 试验地点
- 1
- 主要终点
- Continuous Nicotine Abstinence
研究概览
简要总结
The goal of this clinical research study is learn if varenicline or the nicotine patch can help people with different types of emotion and attention levels to quit smoking.
详细描述
Study Groups:
If you agree to take part in this study, you will be randomly assigned (as in the roll of a dice) to 1 of 2 study groups. This is done because no one knows if one study group is better, the same, or worse than the other group. You will have an equal chance of being assigned to Group 1 or 2.
- If you are in Group 1, you will receive varenicline and a placebo patch. A placebo is not a drug. It looks like the study drug but is not designed to treat any disease or illness. It is designed to be compared with a study drug to learn if the study drug has any real effect.
- If you are in Group 2, you will receive an active nicotine patch and a placebo tablet.
Neither you nor the study doctor will know which group you are assigned to. However, if needed for your safety, the study staff will be able to find out what you are receiving (called "unblinding").
Once the study has ended and the Data Safety Monitoring Board (DSMB) at MD Anderson has granted approval, you may be unblinded at your request.
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 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Age: 18-75 years old
- •Smoking 5 or more cigarettes, Little cigars and/or cigarillos per day, on average, within the 2 months preceding the screening visit and expired CO ≥ 6ppm (if ≤ 5, then NicAlert Strip >2).
- •Interested in treatment that might change smoking behavior
- •Able to follow verbal and written instructions in English and complete all aspects of the study
- •Provide informed consent and agree to all assessments and study procedures
- •Have an address and telephone number where they may be reached
- •Be the only participant in their household
排除标准
- •Standard criteria for transdermal nicotine and varenicline smoking cessation trials will be used.
- •Exclusion criteria will include the following:
- •Within the month immediately preceding the screening visit, use of any form of tobacco products other than cigarettes, little cigars and/or cigarillos on 3 or more days within a week if the individual refuses to refrain from such tobacco use during the course of the study.
- •Current enrollment or plans to enroll in another smoking cessation program in the next 12 months
- •Plan to use other nicotine substitutes (i.e., OTC or prescription medication for smoking cessation) or smoking cessation treatments in the next 12 months
- •Uncontrolled hypertension (SBP greater than 180 or DBP greater than 110)
- •Reports diagnosis of seizure disorder or a history of neurological illness or closed head injury that in the opinion of the PI feels that it would affect the results of the EEG
- •History of severe kidney disease (e.g. chronic or acute kidney failure) with creatinine clearance below 30 and/or severe liver disease with liver tests over 4 times the upper normal level.
- •Laboratory evaluations (kidney and liver) outside normal limits and of potential clinical significance in the opinion of the investigator
- •Serious or unstable disease within the past 3 months
- •History (last 3 months) of abnormal heart rhythms, cardiovascular disease (stroke, angina, heart attack) may result in ineligibility. These conditions will be evaluated on a case by case basis by the Study Physician.
- •Current use of certain medications: (1) Smoking cessation meds (last 7 days), i.e., Wellbutrin, Bupropion, Zyban, NRT, Chantix, (2) Certain medications to treat depression (last 14 days), i.e.
- •MAOIs and Elavil (Amitriptyline), (3) A case by case determination will be made by study physician for medication on precautionary list, i.e. nitroglycerin, or (4) Daily use of opioids for 30 days or more on phone screen or at screening is exclusionary however PRN use is allowed (i.e., 3:7 days per week or less or if more frequent, use less than a month's duration.) --Meet criteria for the following psychiatric and/or substance use disorders as assessed by the MINI: items C (current manic or hypomanic episode only), I (alcohol abuse - Alcohol Addendum-past 6 months only; current alcohol dependence), J (substance abuse - Substance Abuse Addendum - past 6 months only; current substance dependence), K (current/lifetime psychotic disorder or current/lifetime mood disorder with psychotic features).
- •Individuals who meet criteria for non-exclusionary psychiatric disorders that are considered clinically unstable and/or unsuitable to participate as determined by the Principal Investigator and/or Study Physician.
- •Individuals rated as moderate (9-16) to high (17 or greater) on suicidality as assessed by Module B of the MINI. --Psychiatric hospitalization within 1 year of screening date. --A positive urine pregnancy test during the screening period. Women who are two years postmenopausal, or who have had a tubal ligation or a partial or full hysterectomy will not be subject to a urine pregnancy test. --Pregnant, breast-feeding or of childbearing potential and is not protected by a medically acceptable, effective method of birth control while enrolled in the study. Medically acceptable contraceptives include: (1) approved hormonal contraceptives (such as birth control pills, patches, implants or injections), (2) barrier methods (such as a condom or diaphragm) used with a spermicide, or (3) an intrauterine device (IUD). Contraceptive measures sold for emergency use after unprotected sex are not acceptable methods for routine use. --History of hypersensitivity or allergic reaction to Varenicline, NRT, or any component of these formulations . --Any medical or psychiatric condition, illness, disorder, or concomitant medication that could compromise participant safety or treatment, as determined by the Principal Investigator and/or Study Physician.
- •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.
- •Positive toxicology screen for any of the following drugs: cocaine, opiates, methadone, benzodiazepines, barbiturates, amphetamines, methamphetamines, PCP, or THC.
- •A. Participants with valid prescriptions for opiates, benzodiazepines, barbiturates, amphetamines or methadone will not be excluded. B. Participants failing the toxicology screen will be allowed to re-screen once. If they test positive again, they will not be allowed to return.
- •Must not have visual problems that in the investigators opinion would interfere in the completion of the study assessments
- •Unwilling to change hairstyle or remove a wig as necessary for the appointment to accommodate the net that is required to be worn on the scalp during the study procedure.
研究组 & 干预措施
Nicotine Patch + Placebo Tablet
Participant takes placebo tablet 1-10 days after Visit 1. On Days 1-3, participant takes 1 dose of the placebo each morning. Starting on Day 4, and then every day after that, participant takes 1 dose in the morning and 1 dose in the evening.
Starting on Day 8, and then every day after that, participant applies 1 nicotine patch.
Questionnaire completion 1 to 10 days before first study drug/placebo dose and on Days 8, 17, 24, 31, 38, 52, and 73. On Days 17, 24, 38, and 73, done over the phone.
Counseling sessions performed on Days 8, 17, 24, 31, 38, 52, and 73. On Days 17, 24, 38, and 73, done over the phone. During counseling on Day 8, participant sets a "quit date" for stopping smoking for about 1 week after participant starts taking the study drug/placebo.
Study staff calls participant 1 day before quit date and 3 days after quit date to check on progress in quitting smoking.
干预措施: Placebo Tablet (Drug)
Nicotine Patch + Placebo Tablet
Participant takes placebo tablet 1-10 days after Visit 1. On Days 1-3, participant takes 1 dose of the placebo each morning. Starting on Day 4, and then every day after that, participant takes 1 dose in the morning and 1 dose in the evening.
Starting on Day 8, and then every day after that, participant applies 1 nicotine patch.
Questionnaire completion 1 to 10 days before first study drug/placebo dose and on Days 8, 17, 24, 31, 38, 52, and 73. On Days 17, 24, 38, and 73, done over the phone.
Counseling sessions performed on Days 8, 17, 24, 31, 38, 52, and 73. On Days 17, 24, 38, and 73, done over the phone. During counseling on Day 8, participant sets a "quit date" for stopping smoking for about 1 week after participant starts taking the study drug/placebo.
Study staff calls participant 1 day before quit date and 3 days after quit date to check on progress in quitting smoking.
干预措施: Questionnaires (Behavioral)
Nicotine Patch + Placebo Tablet
Participant takes placebo tablet 1-10 days after Visit 1. On Days 1-3, participant takes 1 dose of the placebo each morning. Starting on Day 4, and then every day after that, participant takes 1 dose in the morning and 1 dose in the evening.
Starting on Day 8, and then every day after that, participant applies 1 nicotine patch.
Questionnaire completion 1 to 10 days before first study drug/placebo dose and on Days 8, 17, 24, 31, 38, 52, and 73. On Days 17, 24, 38, and 73, done over the phone.
Counseling sessions performed on Days 8, 17, 24, 31, 38, 52, and 73. On Days 17, 24, 38, and 73, done over the phone. During counseling on Day 8, participant sets a "quit date" for stopping smoking for about 1 week after participant starts taking the study drug/placebo.
Study staff calls participant 1 day before quit date and 3 days after quit date to check on progress in quitting smoking.
干预措施: Counseling Sessions (Behavioral)
Varenicline + Placebo Patch
Varenicline dosing follows the recommended 12 week course: 0.5 milligram mg/day by mouth for Days 1-3, 0.5 mg twice a day for Days 4-7, and 1 mg twice a day thereafter. Participant takes Varenicline 1-10 days after Visit 1.
Starting on Day 8, and then every day after that, participant applies 1 placebo patch each day.
Questionnaire completion 1 to 10 days before first study drug/placebo dose and on Days 8, 17, 24, 31, 38, 52, and 73. On Days 17, 24, 38, and 73, done over the phone.
Counseling sessions performed on Days 8, 17, 24, 31, 38, 52, and 73. On Days 17, 24, 38, and 73, done over the phone. During counseling on Day 8, participant sets a "quit date" for stopping smoking for about 1 week after participant starts taking the study drug/placebo. Some of the counseling sessions may be recorded by video and/or audio tape.
Study staff calls participant 1 day before quit date and 3 days after quit date to check on progress in quitting smoking.
干预措施: Placebo Patch (Drug)
Varenicline + Placebo Patch
Varenicline dosing follows the recommended 12 week course: 0.5 milligram mg/day by mouth for Days 1-3, 0.5 mg twice a day for Days 4-7, and 1 mg twice a day thereafter. Participant takes Varenicline 1-10 days after Visit 1.
Starting on Day 8, and then every day after that, participant applies 1 placebo patch each day.
Questionnaire completion 1 to 10 days before first study drug/placebo dose and on Days 8, 17, 24, 31, 38, 52, and 73. On Days 17, 24, 38, and 73, done over the phone.
Counseling sessions performed on Days 8, 17, 24, 31, 38, 52, and 73. On Days 17, 24, 38, and 73, done over the phone. During counseling on Day 8, participant sets a "quit date" for stopping smoking for about 1 week after participant starts taking the study drug/placebo. Some of the counseling sessions may be recorded by video and/or audio tape.
Study staff calls participant 1 day before quit date and 3 days after quit date to check on progress in quitting smoking.
干预措施: Questionnaires (Behavioral)
Varenicline + Placebo Patch
Varenicline dosing follows the recommended 12 week course: 0.5 milligram mg/day by mouth for Days 1-3, 0.5 mg twice a day for Days 4-7, and 1 mg twice a day thereafter. Participant takes Varenicline 1-10 days after Visit 1.
Starting on Day 8, and then every day after that, participant applies 1 placebo patch each day.
Questionnaire completion 1 to 10 days before first study drug/placebo dose and on Days 8, 17, 24, 31, 38, 52, and 73. On Days 17, 24, 38, and 73, done over the phone.
Counseling sessions performed on Days 8, 17, 24, 31, 38, 52, and 73. On Days 17, 24, 38, and 73, done over the phone. During counseling on Day 8, participant sets a "quit date" for stopping smoking for about 1 week after participant starts taking the study drug/placebo. Some of the counseling sessions may be recorded by video and/or audio tape.
Study staff calls participant 1 day before quit date and 3 days after quit date to check on progress in quitting smoking.
干预措施: Counseling Sessions (Behavioral)
Varenicline + Placebo Patch
Varenicline dosing follows the recommended 12 week course: 0.5 milligram mg/day by mouth for Days 1-3, 0.5 mg twice a day for Days 4-7, and 1 mg twice a day thereafter. Participant takes Varenicline 1-10 days after Visit 1.
Starting on Day 8, and then every day after that, participant applies 1 placebo patch each day.
Questionnaire completion 1 to 10 days before first study drug/placebo dose and on Days 8, 17, 24, 31, 38, 52, and 73. On Days 17, 24, 38, and 73, done over the phone.
Counseling sessions performed on Days 8, 17, 24, 31, 38, 52, and 73. On Days 17, 24, 38, and 73, done over the phone. During counseling on Day 8, participant sets a "quit date" for stopping smoking for about 1 week after participant starts taking the study drug/placebo. Some of the counseling sessions may be recorded by video and/or audio tape.
Study staff calls participant 1 day before quit date and 3 days after quit date to check on progress in quitting smoking.
干预措施: Lab Session (Other)
Varenicline + Placebo Patch
Varenicline dosing follows the recommended 12 week course: 0.5 milligram mg/day by mouth for Days 1-3, 0.5 mg twice a day for Days 4-7, and 1 mg twice a day thereafter. Participant takes Varenicline 1-10 days after Visit 1.
Starting on Day 8, and then every day after that, participant applies 1 placebo patch each day.
Questionnaire completion 1 to 10 days before first study drug/placebo dose and on Days 8, 17, 24, 31, 38, 52, and 73. On Days 17, 24, 38, and 73, done over the phone.
Counseling sessions performed on Days 8, 17, 24, 31, 38, 52, and 73. On Days 17, 24, 38, and 73, done over the phone. During counseling on Day 8, participant sets a "quit date" for stopping smoking for about 1 week after participant starts taking the study drug/placebo. Some of the counseling sessions may be recorded by video and/or audio tape.
Study staff calls participant 1 day before quit date and 3 days after quit date to check on progress in quitting smoking.
干预措施: Saliva Test (Other)
Nicotine Patch + Placebo Tablet
Participant takes placebo tablet 1-10 days after Visit 1. On Days 1-3, participant takes 1 dose of the placebo each morning. Starting on Day 4, and then every day after that, participant takes 1 dose in the morning and 1 dose in the evening.
Starting on Day 8, and then every day after that, participant applies 1 nicotine patch.
Questionnaire completion 1 to 10 days before first study drug/placebo dose and on Days 8, 17, 24, 31, 38, 52, and 73. On Days 17, 24, 38, and 73, done over the phone.
Counseling sessions performed on Days 8, 17, 24, 31, 38, 52, and 73. On Days 17, 24, 38, and 73, done over the phone. During counseling on Day 8, participant sets a "quit date" for stopping smoking for about 1 week after participant starts taking the study drug/placebo.
Study staff calls participant 1 day before quit date and 3 days after quit date to check on progress in quitting smoking.
干预措施: Lab Session (Other)
Nicotine Patch + Placebo Tablet
Participant takes placebo tablet 1-10 days after Visit 1. On Days 1-3, participant takes 1 dose of the placebo each morning. Starting on Day 4, and then every day after that, participant takes 1 dose in the morning and 1 dose in the evening.
Starting on Day 8, and then every day after that, participant applies 1 nicotine patch.
Questionnaire completion 1 to 10 days before first study drug/placebo dose and on Days 8, 17, 24, 31, 38, 52, and 73. On Days 17, 24, 38, and 73, done over the phone.
Counseling sessions performed on Days 8, 17, 24, 31, 38, 52, and 73. On Days 17, 24, 38, and 73, done over the phone. During counseling on Day 8, participant sets a "quit date" for stopping smoking for about 1 week after participant starts taking the study drug/placebo.
Study staff calls participant 1 day before quit date and 3 days after quit date to check on progress in quitting smoking.
干预措施: Saliva Test (Other)
Varenicline + Placebo Patch
Varenicline dosing follows the recommended 12 week course: 0.5 milligram mg/day by mouth for Days 1-3, 0.5 mg twice a day for Days 4-7, and 1 mg twice a day thereafter. Participant takes Varenicline 1-10 days after Visit 1.
Starting on Day 8, and then every day after that, participant applies 1 placebo patch each day.
Questionnaire completion 1 to 10 days before first study drug/placebo dose and on Days 8, 17, 24, 31, 38, 52, and 73. On Days 17, 24, 38, and 73, done over the phone.
Counseling sessions performed on Days 8, 17, 24, 31, 38, 52, and 73. On Days 17, 24, 38, and 73, done over the phone. During counseling on Day 8, participant sets a "quit date" for stopping smoking for about 1 week after participant starts taking the study drug/placebo. Some of the counseling sessions may be recorded by video and/or audio tape.
Study staff calls participant 1 day before quit date and 3 days after quit date to check on progress in quitting smoking.
干预措施: Varenicline (Drug)
Nicotine Patch + Placebo Tablet
Participant takes placebo tablet 1-10 days after Visit 1. On Days 1-3, participant takes 1 dose of the placebo each morning. Starting on Day 4, and then every day after that, participant takes 1 dose in the morning and 1 dose in the evening.
Starting on Day 8, and then every day after that, participant applies 1 nicotine patch.
Questionnaire completion 1 to 10 days before first study drug/placebo dose and on Days 8, 17, 24, 31, 38, 52, and 73. On Days 17, 24, 38, and 73, done over the phone.
Counseling sessions performed on Days 8, 17, 24, 31, 38, 52, and 73. On Days 17, 24, 38, and 73, done over the phone. During counseling on Day 8, participant sets a "quit date" for stopping smoking for about 1 week after participant starts taking the study drug/placebo.
Study staff calls participant 1 day before quit date and 3 days after quit date to check on progress in quitting smoking.
干预措施: Nicotine Patch (Drug)
结局指标
主要结局
Continuous Nicotine Abstinence
时间窗: 8 weeks
Continuous abstinence over the last 4 weeks of treatment (i.e. EOT-end of treatment) will serve as the primary outcome measure. Saliva will be collected to measure cotinine level.
次要结局
- Continuous and Prolonged Nicotine Abstinence(3 months)