Exenatide Once Weekly for Smoking Cessation: A Randomized Clinical Trial
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 84
- 试验地点
- 1
- 主要终点
- Number of Participants Who Self-Reported Abstinence and Who Were Biochemically Verified as Abstinent Via Expired CO Level of ≤ 5ppm
研究概览
简要总结
The purpose of this study is to identify a potential new treatment for smoking cessation.
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
- Triple (Participant, Investigator, Outcomes Assessor)
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
- 否
入选标准
- •Be English-speaking volunteers who desire to quit smoking and are willing to make a quit attempt during the course of the study;
- •Have smoked ≥10 cigarettes a day for at least one year and provide a breath carbon monoxide (CO) ≥10 ppm;
- •Have a negative pregnancy test, if female of childbearing potential;
- •Have HbA1C levels between 5.7 and 6.4% or BMI of or greater than 25 kg/square meters
- •Not currently using any therapy for glycemic control (either injectable [i.e. insulin] or oral agents);
- •Have vital signs as follows: resting pulse between 50 and 95 bpm, BP between 90-150 mmHg systolic and 45-95 mmHg diastolic;
- •Have hematology and chemistry laboratory tests that are within reference limits (within 10% above or below), with the following exception: pancreatic tests (lipase and amylase) must be within normal limits;
- •Have a medical history and brief physical examination demonstrating no clinically significant contraindications for study participation, in the judgment of the principal investigator.
排除标准
- •Meet criteria for the following psychiatric and/or substance use disorders as assessed by the Mini International Neuropsychiatric Interview (MINI): items C (current manic or hypomanic episode only), I (alcohol abuse - Alcohol Addendum-past 3 months only; current alcohol dependence), J (substance abuse -Substance Abuse Addendum - past 3 months only; current substance dependence), K (current psychotic disorder or current 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.
- •Have personal or family history of medullary thyroid carcinoma or multiple endocrine neoplasia syndrome type 2;
- •Have type 1 diabetes mellitus;
- •Have severe cardiovascular disease (history of myocardial infarction, life-threatening arrhythmia, or worsening angina pectoris);
- •Have active temporomandibular joint disease;
- •Have severe gastrointestinal disease (i.e. severe gastroparesis);
- •Have previous history of pancreatitis or are at risk for pancreatitis;
- •Have creatinine clearance (CrCl) < 30;
- •Have any previous medically adverse reaction to study medications, nicotine, or menthol;
- •Be pregnant or lactating or unwilling to provide a negative pregnancy test before study entry;
- •Not using a reliable form of contraception (e.g., abstinence, birth control pills, intrauterine device, condoms, or spermicide);
- •Have any illness which in the opinion of the primary investigator would preclude safe and/or successful completion of the study.
研究组 & 干预措施
Exenatide plus NRT plus counseling
Once weekly exenatide Injectable Product, Nicotine Replacement Therapy (NRT) Patch, smoking cessation counseling
干预措施: Exenatide (Drug)
Exenatide plus NRT plus counseling
Once weekly exenatide Injectable Product, Nicotine Replacement Therapy (NRT) Patch, smoking cessation counseling
干预措施: NRT (Drug)
Exenatide plus NRT plus counseling
Once weekly exenatide Injectable Product, Nicotine Replacement Therapy (NRT) Patch, smoking cessation counseling
干预措施: Counseling (Behavioral)
Placebo plus NRT plus counseling
Once weekly placebo, Nicotine Replacement Therapy (NRT) Patch, smoking cessation counseling
干预措施: NRT (Drug)
Placebo plus NRT plus counseling
Once weekly placebo, Nicotine Replacement Therapy (NRT) Patch, smoking cessation counseling
干预措施: Counseling (Behavioral)
Placebo plus NRT plus counseling
Once weekly placebo, Nicotine Replacement Therapy (NRT) Patch, smoking cessation counseling
干预措施: Placebo (Drug)
结局指标
主要结局
Number of Participants Who Self-Reported Abstinence and Who Were Biochemically Verified as Abstinent Via Expired CO Level of ≤ 5ppm
时间窗: 6 weeks
Cue-induced Craving for Cigarettes Following Virtual Reality Exposure as Assessed by the Questionnaire of Smoking Urges
时间窗: 3 weeks
Questionnaire of Smoking Urges (QSU) is a 10-item scale (total score range = 10-70, a lower score indicates lower cravings for cigarettes) that evaluates the intention and desire to smoke and anticipation of relief from withdrawal-associated negative affect.
Post-quit Craving as Assessed by the Questionnaire of Smoking Urges
时间窗: 6 weeks
Questionnaire of Smoking Urges (QSU) is a 10-item scale (total score range = 10-70, a lower score indicates lower cravings for cigarettes) that evaluates the intention and desire to smoke and anticipation of relief from withdrawal-associated negative affect.
Withdrawal Symptoms as Assessed by the Wisconsin Smoking Withdrawal Scale
时间窗: 6 weeks
The Wisconsin Smoking Withdrawal Scale is a 28-item questionnaire designed to assess different aspects of the smoking withdrawal syndrome. Participants rate each item on a Likert scale from zero (strongly disagree) to four (strongly agree). Total score ranges from 0 to 112, with a higher score indicating greater withdrawal.
次要结局
- Post-quit Craving as Assessed by the Questionnaire of Smoking Urges(10 weeks (4 weeks after end of treatment))
- Number of Participants Who Self-Reported Abstinence and Who Were Biochemically Verified as Abstinent Via Expired CO Level of ≤ 5ppm(10 weeks (4 weeks after end of treatment))
研究者
Luba Yammine
Associate Professor
The University of Texas Health Science Center, Houston