Examining the Effects of Cytisinicline on Neural Substrates of Cigarette Cue-Reactivity
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 入组人数
- 64
- 试验地点
- 1
- 主要终点
- Blood-oxygen-level-dependent (BOLD) activation to cigarette cues during fMRI task
研究概览
简要总结
This study will randomize 64 non-treatment seeking individuals who smoke cigarettes daily in a double-blind, placebo-controlled laboratory study testing the effects of cytisinicline on the neural substrates of cigarette cue reactivity.
详细描述
The objective of this study is to examine the effects of cytisinicline on neural substrates of cigarette cue-reactivity. We will randomize 64 adults who smoke cigarettes daily (N=32 cytisinicline, N=32 placebo; 50% female) into a double-blind, placebo-controlled laboratory study of cytisinicline. Specifically, participants will complete a 2- to 3-week outpatient protocol that includes taking cytisinicline (3 mg, 3 times daily) or matched placebo (0 mg, 3 times daily) and completing a brief daily diary assessment of cigarette use and craving. Following 2- to 3-weeks of cytisinicline (or placebo) treatment, participants will complete a cigarette cue-exposure task during fMRI. Total study participation will be approximately 4 weeks.
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, 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
- 否
入选标准
- •be between the ages of 18 and 65 and provide informed consent;
- •smoke 5 or more combustible cigarettes per day;
- •not seeking treatment for smoking;
排除标准
- •current use of other smoking cessation aid (bupropion, varenicline, nortriptyline, NRT);
- •more than 3 months of smoking abstinence in past year;
- •use of non-cigarette tobacco product (pipe tobacco, cigars, smokeless tobacco, hookah) or electronic cigarettes more than 5 times in the 28-days prior to enrollment;
- •current use of psychoactive drug (excluding cannabis), as determined by urine toxicology;
- •current (past 12-month) DSM-5 diagnosis of substance use disorder for any substances other than tobacco and mild cannabis or mild-to-moderate alcohol use disorders;
- •lifetime history of psychotic disorders, bipolar disorders, or major depression with suicidal ideation;
- •current suicidal ideation or lifetime history of suicide attempt;
- •serious medical illness within past 3 months, including recent history of acute myocardial infarction, unstable angina, stroke, cerebrovascular incident, or hospitalization for congestive heart failure;
- •medical condition that may interfere with safe study participation;
- •renal impairment defined as a creatinine clearance (CrCl) greater than 60 mL/min (estimated with the Cockroft-Gault equation);
- •exceed Grade 2 laboratory abnormalities, based on FDA Guidance Document "Toxicity Grading Scale for Healthy Adult and Adolescent Volunteers Enrolled in Preventive Vaccine Clinical Trials";
- •uncontrolled hypertension (blood pressure ≥160/100 mmHg);
- •abnormal electrocardiogram;
- •non-removable ferromagnetic object in body;
- •claustrophobia;
- •serious head injury or period of unconsciousness (more than 30 minutes);
- •more than 250lbs;
- •Be pregnant, nursing, or planning to become pregnant while taking part in the study; and must agree to one of the following methods of birth control (if female), unless she or partner are surgically sterile:
- •Oral contraceptives
- •Contraceptive sponge
- •Double barrier
- •Intrauterine contraceptive device
- •Etonogestrel implant
- •Medroxyprogesterone acetate contraceptive injection
- •Hormonal vaginal contraceptive ring
- •Complete abstinence from sexual intercourse;
- •have experienced adverse effects to varenicline;
- •have an intense fear of needles or have had an adverse reaction to needle puncture.
研究组 & 干预措施
Cytisinicline
3mg cytisinicline oral capsule 3 times daily for 2-to-3 weeks
干预措施: Cytisinicline (Drug)
Placebo
matched to experimental drug
干预措施: Placebo Oral Capsule (Drug)
结局指标
主要结局
Blood-oxygen-level-dependent (BOLD) activation to cigarette cues during fMRI task
时间窗: From enrollment to end of treatment at 2-to-3 weeks
Participants will complete a cigarette cue-exposure task during fMRI. In this paradigm, participants are exposed to videotaped cues of smoking and control, non-cigarette related, content. Blood-oxygen-level-dependent (BOLD) activation to cigarette (vs. non-cigarette control ) cues will be calculated.
次要结局
- In-scanner cigarette cue-induced subjective craving(From enrollment to end of treatment at 2-to-3 weeks)
- Subjective cigarette craving during outpatient period(From enrollment to end of treatment at 2-to-3 weeks)
研究者
Lara Ray, PhD
Professor
University of California, Los Angeles