The Effects of Sedatives on Tobacco Use Disorder Version 2
试验速览
- 阶段
- 早期 1 期
- 状态
- 已完成
- 入组人数
- 20
- 试验地点
- 1
- 主要终点
- Difference in tobacco withdrawal symptoms
研究概览
简要总结
Double-blind, placebo-controlled, randomized mechanistic clinical trial to test an intravenous dose of either ketamine, midazolam, dexmedetomidine, or a placebo (saline) on cigarette smoking behavior, craving, and neural effects.
详细描述
This double-blind, placebo-controlled, randomized mechanistic clinical trial will test non-treatment seeking smokers with an intravenous infusion of ketamine (0.71 mg/kg), midazolam (0.025 mg/kg), dexmedetomidine (0.025 mg/kg), or placebo, at least 2 weeks apart. Participants will complete 7-day ecological momentary assessment (EMA) of daily craving, withdrawal, and smoking behavior before and after each infusion. They will be asked to abstain from tobacco/nicotine for twenty-four hours post-infusion to induce withdrawal symptoms and return to the lab the following day to complete measures of craving, withdrawal, an MRI scan, and smoking latency. After this study visit, participants will be allowed to smoke as usual for the rest of the EMA diary period. Physical and subjective effects and adverse effects will be closely monitored throughout.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Basic Science
- 盲法
- Double (Participant, Care Provider)
入排标准
- 年龄范围
- 21 Years 至 55 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Smokes cigarettes daily for at least 2 years
- •Afternoon expired breath carbon monoxide at least 5 ppm or morning urinary cotinine at least 100 ng/ml
- •Negative urine drug screen for psychoactive drugs and negative breath alcohol
排除标准
- •Have an unstable medical condition or stable medical condition that would interact with study drug or participation, including chronic pulmonary disease, coronary artery disease, current brain tumor, current increased intracranial pressure or impaired consciousness
- •History of serious head trauma or neurological disorder (e.g., seizure disorder)
- •Have any of the following: hypertension (i.e., systolic >140 mm Hg and/or diastolic >90 mm Hg on three separate measures; systolic >170 or diastolic > 110 on any occasion), pre-existing severe gastrointestinal narrowing (pathologic or iatrogenic).
- •Use of drugs that would interact with study drug or increase risk of adverse events
- •Among women, pregnancy or lactation
研究组 & 干预措施
Saline first injection; ketamine second injection
Subjects in this arm will receive a single intravenous infusion of placebo at the first injection visit and a single intravenous infusion ketamine at the second injection visit.
干预措施: Ketamine (Drug)
Saline first injection; ketamine second injection
Subjects in this arm will receive a single intravenous infusion of placebo at the first injection visit and a single intravenous infusion ketamine at the second injection visit.
干预措施: Saline (Drug)
Saline first injection; midazolam second injection
Subjects in this arm will receive a single intravenous infusion of placebo at the first injection visit and a single intravenous infusion midazolam at the second injection visit
干预措施: Midazolam (Drug)
Saline first injection; midazolam second injection
Subjects in this arm will receive a single intravenous infusion of placebo at the first injection visit and a single intravenous infusion midazolam at the second injection visit
干预措施: Saline (Drug)
Saline first injection; dexmedetomidine second injection
Subjects in this arm will receive a single intravenous infusion of placebo at the first injection visit and a single intravenous infusion dexmedetomidine at the second injection visit.
干预措施: Dexmedetomidine (Drug)
Saline first injection; dexmedetomidine second injection
Subjects in this arm will receive a single intravenous infusion of placebo at the first injection visit and a single intravenous infusion dexmedetomidine at the second injection visit.
干预措施: Saline (Drug)
Ketamine first injection; Saline second injection
Subjects in this arm will receive a single intravenous infusion of ketamine at the first injection visit and a single intravenous infusion placebo at the second injection visit.
干预措施: Ketamine (Drug)
Ketamine first injection; Saline second injection
Subjects in this arm will receive a single intravenous infusion of ketamine at the first injection visit and a single intravenous infusion placebo at the second injection visit.
干预措施: Saline (Drug)
Ketamine first injection; midazolam second injection
Subjects in this arm will receive a single intravenous infusion of ketamine at the first injection visit and a single intravenous infusion midazolam at the second injection visit.
干预措施: Ketamine (Drug)
Ketamine first injection; midazolam second injection
Subjects in this arm will receive a single intravenous infusion of ketamine at the first injection visit and a single intravenous infusion midazolam at the second injection visit.
干预措施: Midazolam (Drug)
Ketamine first injection; dexmedetomidine second injection
Subjects in this arm will receive a single intravenous infusion of ketamine at the first injection visit and a single intravenous infusion dexmedetomidine at the second injection visit.
干预措施: Ketamine (Drug)
Ketamine first injection; dexmedetomidine second injection
Subjects in this arm will receive a single intravenous infusion of ketamine at the first injection visit and a single intravenous infusion dexmedetomidine at the second injection visit.
干预措施: Dexmedetomidine (Drug)
Midazolam first injection; Saline second injection
Subjects in this arm will receive a single intravenous infusion of midazolam at the first injection visit and a single intravenous infusion placebo at the second injection visit.
干预措施: Midazolam (Drug)
Midazolam first injection; Saline second injection
Subjects in this arm will receive a single intravenous infusion of midazolam at the first injection visit and a single intravenous infusion placebo at the second injection visit.
干预措施: Saline (Drug)
Midazolam first injection; ketamine second injection
Subjects in this arm will receive a single intravenous infusion of midazolam at the first injection visit and a single intravenous infusion ketamine at the second injection visit.
干预措施: Ketamine (Drug)
Midazolam first injection; ketamine second injection
Subjects in this arm will receive a single intravenous infusion of midazolam at the first injection visit and a single intravenous infusion ketamine at the second injection visit.
干预措施: Midazolam (Drug)
Midazolam first injection; dexmedetomidine second injection
Subjects in this arm will receive a single intravenous infusion of midazolam at the first injection visit and a single intravenous infusion dexmedetomidine at the second injection visit.
干预措施: Midazolam (Drug)
Midazolam first injection; dexmedetomidine second injection
Subjects in this arm will receive a single intravenous infusion of midazolam at the first injection visit and a single intravenous infusion dexmedetomidine at the second injection visit.
干预措施: Dexmedetomidine (Drug)
Dexmedetomidine first injection; Saline second injection
Subjects in this arm will receive a single intravenous infusion of dexmedetomidine at the first injection visit and a single intravenous infusion placebo at the second injection visit.
干预措施: Dexmedetomidine (Drug)
Dexmedetomidine first injection; Saline second injection
Subjects in this arm will receive a single intravenous infusion of dexmedetomidine at the first injection visit and a single intravenous infusion placebo at the second injection visit.
干预措施: Saline (Drug)
Dexmedetomidine first injection; ketamine second injection
Subjects in this arm will receive a single intravenous infusion of dexmedetomidine at the first injection visit and a single intravenous infusion ketamine at the second injection visit.
干预措施: Ketamine (Drug)
Dexmedetomidine first injection; ketamine second injection
Subjects in this arm will receive a single intravenous infusion of dexmedetomidine at the first injection visit and a single intravenous infusion ketamine at the second injection visit.
干预措施: Dexmedetomidine (Drug)
Dexmedetomidine first injection; midazolam second injection
Subjects in this arm will receive a single intravenous infusion of dexmedetomidine at the first injection visit and a single intravenous infusion midazolam at the second injection visit.
干预措施: Midazolam (Drug)
Dexmedetomidine first injection; midazolam second injection
Subjects in this arm will receive a single intravenous infusion of dexmedetomidine at the first injection visit and a single intravenous infusion midazolam at the second injection visit.
干预措施: Dexmedetomidine (Drug)
结局指标
主要结局
Difference in tobacco withdrawal symptoms
时间窗: 24-hours post infusion
difference in self-reported withdrawal symptoms after infusions
Difference in craving between drug and placebo
时间窗: 24-hours post infusion
difference in self-reported craving for cigarettes after infusions
Number of cigarettes smoked ad lib
时间窗: 24-hours post infusion
Difference in cigarette demand
时间窗: 24-hours post infusion
difference in self-reported cigarette demand after infusions
次要结局
未报告次要终点