Impact of Sweeteners on the Addictive Threshold of Nicotine
2026年8月26日 更新者：Yale University
To determine if sucralose, an artificial sweetener, modulates nicotine threshold doses for discrimination, subjective-rewarding effects, and reinforcement in smokers with varying levels of dependence.
研究概览
地位
尚未招聘
条件
详细说明
Participants will complete an Adaptation Session followed by four Test Days.
The Adaptation Session will familiarize participants with all study procedures.
On each Test Day, a specific intravenous nicotine dose (0.05 or 0.1 mg/pulse) is paired with either a sucralose or control flavor administered by an electronic cigarette.
The experimental procedure begins with a sampling phase comparing the assigned nicotine dose against saline, each paired with the assigned flavor, followed by four trials to assess the participant's ability to discriminate between the two conditions.
Subsequently, participants complete four Choice trials, where they will choose between receiving the assigned nicotine dose and saline.
Reinforcement will be measured by the percentage of nicotine choices, while discrimination will be measured by the percentage of correctly identified infusions.
Subjective rewarding effects will be assessed using the "Pleasurable Effects" composite score of the Drug Effects Questionnaire (DEQ).
研究类型
介入性
注册 (估计的)
36
阶段
- 阶段1
联系人和位置
本节提供了进行研究的人员的详细联系信息，以及有关进行该研究的地点的信息。
学习联系方式
- 姓名：Mehmet Sofuoglu, M.D., Ph.D.
- 电话号码：203-932-5711
- 邮箱：Mehmet.Sofuoglu@yale.edu
研究联系人备份
- 姓名：Stacy A Minnix, B.S.
- 电话号码：203--932-5711
学习地点
-
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Connecticut
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West Haven、Connecticut、美国、06516
- VA Hospital
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参与标准
研究人员寻找符合特定描述的人，称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。
资格标准
适合学习的年龄
- 成人
接受健康志愿者
不
描述
Inclusion Criteria:
- Smoking at least for one year and more frequently than once a week, smoking status confirmed with a semi-quantitative urine nicotine test. Smokers will be stratified by level of dependence, assessed with the FTND 29 low or no dependence ≤3 and moderate or high dependence ≥ 4.
- In good health as verified by medical history, screening examination, and screening laboratory tests.
- For women, report using acceptable birth control methods.
Exclusion Criteria:
- History of major medical or psychiatric disorders that the physician investigator deems as contraindicated for the participant to be in the study;
- regular current use of certain psychotropic medications (such as mood stabilizers, antipsychotics, or anxiolytics being prescribed to treat bipolar disorder, psychosis or anxiety spectrum disorders, respectively);
- current untreated alcohol or substance use disorder for any other recreational or prescription drugs other than nicotine;
- for women, pregnant as determined by pregnancy screening, or breastfeeding; and 5) seeking (or undergoing) treatment for tobacco dependence or smoking.
学习计划
本节提供研究计划的详细信息，包括研究的设计方式和研究的衡量标准。
研究是如何设计的？
设计细节
- 主要用途：卫生服务研究
- 分配：随机化
- 介入模型：交叉作业
- 屏蔽：双倍的
武器和干预
参与者组/臂 |
干预/治疗 |
|---|---|
|
有源比较器：Nicotine
These test days will evaluate two nicotine doses (0.05 mg/pulse and 0.1 mg/pulse)
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Nicotine will be used and compared to saline given by IV push by study physician
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安慰剂比较：saline
Saline (sugar water)
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Saline will be used compared to the low dose of Nicotine given by IV push by study physician
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安慰剂比较：unsweetened flavor
participants practice using the e-cigarette and sample the sweet (sucralose) and control (unsweetened) flavors
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Unsweetened flavor compared to the sweetened flavor sucralose.
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有源比较器：sucralose
participants practice using the e-cigarette and sample the sweet (sucralose) and control (unsweetened) flavors
|
sweet flavor (sucralose) compared to unsweetened flavor
|
研究衡量的是什么？
主要结果指标
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
Drug Discrimination Scale (DDS) score.
大体时间：OnTest Days 1, 2, 3 and 4
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This scale asks the participants to select if they received Drug A or B and how confident they are in their selection on a scale of 0 to 10. Higher scores indicate more confidence.
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OnTest Days 1, 2, 3 and 4
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Drug Effects Questionnaire (DEQ) pleasurable effects score
大体时间：OnTest Days 1, 2, 3 and 4
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The DEQ pleasurable effects consists of 11 questions with total score range from 0-100.
Higher scores indicate more positive effects.
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OnTest Days 1, 2, 3 and 4
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次要结果测量
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
Minnesota Nicotine Withdrawal Scale score
大体时间：OnTest Days 1, 2, 3 and 4
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This 8-item scale will be used to assess DSM-IV symptoms of nicotine withdrawal.
Total score range 0-32.
Higher scores indicate more severe withdrawal symptoms.
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OnTest Days 1, 2, 3 and 4
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合作者和调查者
在这里您可以找到参与这项研究的人员和组织。
调查人员
- 首席研究员：Mehmet Sofuoglu, M.D., Ph.D.、Yale University
研究记录日期
这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查，以确保它们在发布到公共网站之前符合特定的质量控制标准。
研究主要日期
学习开始 (估计的)
2026年9月1日
初级完成 (估计的)
2029年9月1日
研究完成 (估计的)
2029年12月31日
研究注册日期
首次提交
2026年8月13日
首先提交符合 QC 标准的
2026年8月13日
首次发布 (实际的)
2026年8月18日
研究记录更新
最后更新发布 (实际的)
2026年8月31日
上次提交的符合 QC 标准的更新
2026年8月26日
最后验证
2026年8月1日
更多信息
此信息直接从 clinicaltrials.gov 网站检索，没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求，请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改，我们的网站上也会自动更新.