此页面是自动翻译的,不保证翻译的准确性。请参阅 英文版 对于源文本。

A Controlled Laboratory Study of the Effects on Cue-Induced Craving in Dependent Smokers (rTMS)

2012年12月17日 更新者:Duke University
The purpose of this study is to investigate the use of repetitive transcranial magnetic stimulation (rTMS) to block craving for cigarettes in smokers. rTMS is an investigational procedure, where a device called a "stimulator" provides electricity to a device that creates a magnetic field. This device is placed against the scalp in the front of the head so that the magnetic field is focused on an area of the brain that is thought to be involved in craving for cigarettes. rTMS is an investigational procedure so therefore being tested in research studies and is not approved by the U.S. Food and Drug Administration (FDA). Changes in magnetic fields during rTMS administration change electrical currents which may affect brain activity and function.

研究概览

详细说明

The goal of this study is to evaluate the effects of rTMS on cue-induced craving in dependent smokers. We hypothesize that low frequency rTMS over the SFG will block cue-induced craving. In order to test this hypothesis, subjects will undergo three conditions:

  1. active condition: low frequency rTMS was administered over the superior frontal gyrus (SFG) during the presentation of smoking and control cues
  2. location control condition: low frequency rTMS was administered over motor cortex (MC) during the presentation of smoking and control cues
  3. frequency control condition: high frequency rTMS was administered over the SFG during the presentation of smoking and control cues

研究类型

介入性

注册 (实际的)

21

阶段

  • 阶段2

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。

学习地点

    • North Carolina
      • Durham、North Carolina、美国、27705
        • Duke Center for Nicotine & Smoking Cessation Research

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

18年 至 50年 (成人)

接受健康志愿者

有资格学习的性别

全部

描述

Inclusion Criteria:

  1. 18 to 50 years of age;
  2. dependent smoker of > 10 cigarettes per day of cigarettes yielding >0.5mg nicotine (by Federal Trade Commission rated yields);
  3. have smoked cigarettes for at least three cumulative years;
  4. an afternoon carbon monoxide reading of at least 10ppm;
  5. be in general good health based on physical examination, EKG, serum chemistries, CBC, and urinalysis and
  6. show evidence of greater craving following exposure to in vivo smoking versus control cues

Exclusion Criteria:

  1. Individuals with a clinically defined neurological disorder or insult including, but not limited to, any condition likely to be associated with increased intracranial pressure;
  2. space occupying brain lesion;
  3. any history of seizure EXCEPT those therapeutically induced by ECT (Electro Convulsive Therapy);
  4. history of cerebrovascular accident;
  5. transient ischemic attack within two years;
  6. cerebral aneurysm;
  7. dementia;
  8. Parkinson's disease;
  9. Huntington's chorea;
  10. multiple sclerosis;
  11. current lung disease or lung disorder;
  12. hypertension (systolic >140 mmHg, diastolic > 90 mmHg);
  13. hypotension (< 90 mmHg, diastolic < 60 mmHg);
  14. coronary artery disease;
  15. cardiac rhythm disorder;
  16. impaired hepatic or renal function (based on documented diagnosis or abnormal chemistries) except gallstones or kidney stones;
  17. other major medical or psychiatric condition;
  18. use of any concurrent hypertensive, psychiatric, or psychoactive medication;
  19. any concurrent medication that lowers seizure threshold;
  20. smokeless tobacco, pipe, or cigar use in the past 30 days;
  21. nicotine replacement therapy, or other smoking cessation therapy within the past 30 days;
  22. increased risk of seizure for any reason, including prior diagnosis of increased intracranial pressure (such as after large infarctions or trauma), or history of significant head trauma with loss of consciousness for > 5 minutes;
  23. ECT treatment within 3 months prior to screening visit;
  24. failure to respond to ECT treatment (i.e., consistent with ATHF level 2 or higher);
  25. a true positive response to any question on the Transcranial Magnetic Stimulation Adult Safety Screen questionnaire;
  26. history of treatment with rTMS therapy for any disorder;
  27. use of any investigational drug within 30 days of the screening visit;
  28. history of treatment with Vagus Nerve Stimulation;
  29. use of any medication(s) with active CNS properties within 1 week of the screening visit;
  30. cardiac pacemakers, implanted medication pumps, intracardiac lines, or acute, unstable cardiac disease; intracranial implant (e.g., aneurysm clips, shunts, stimulators, cochlear implants, or electrodes) or any other metal object within or near the head, excluding the mouth, that cannot be safely removed;
  31. known or suspected pregnancy;
  32. positive urine drug screen or reported drug abuse in the past 30 days;
  33. clinically significant laboratory abnormality, in the opinion of the investigator or study physician;
  34. women who are breast-feeding; women of child-bearing potential not using a medically accepted form of contraception when engaging in sexual intercourse;
  35. current chronic pain or other pain condition that interferes with daily activities or requires use of prescription medication;
  36. claustrophobia or abnormal fear of cramped or confined space;
  37. Individuals where a motor threshold response is not elicited with stimulation at or below 80% of maximum output;
  38. active ulcer within the past 30 days;
  39. frequent migraines (great than four in the past 30 days);
  40. Females who score greater than or equal to 13 and males who score greater than or equal to 15 on the AUDIT (Alcohol Use Disorders Identification Test)will be excluded from the study.

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:治疗
  • 分配:随机化
  • 介入模型:交叉作业
  • 屏蔽:单身的

武器和干预

参与者组/臂
干预/治疗
有源比较器:rTMS 90% MT - Low frequency rTMS
Intervention type: device. Intervention description: low frequency rTMS was administered over the superior frontal gyrus (SFG) during the presentation of smoking and control cues using 90% MT (Motor Threshold) 1 Hz rTMS Dose on Superior Frontal Gyrus
Low frequency rTMS (90% Motor Threshold at 1 HZ) will be administered over the superior frontal gyrus (SFG) during the presentation of smoking and control cues.
有源比较器:Location Control
rTMS Dosing: 90% MT (Motor Threshold) 1 Hz rTNS Location: Motor Cortex
Low frequency rTMS (90% Motor Threshold at 1 HZ) will be administered over the motor cortex (MC) during the presentation of smoking and control cues.
有源比较器:Frequency Control
rTMS Dosing: 90% MT (Motor Threshold) 10 Hz rTNS Location: Superior Frontal Gyrus
High frequency rTMS (90% Motor Threshold at 10 HZ) will be administered over the superior frontal gyrus (SFG) during the presentation of smoking and control cues.

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
Change in Craving for Cigarettes After Smoking Cues Versus Neutral Cues Using a Repeated Measure Design.
大体时间:Following exposure to in vivo cues
Cigarette craving was assessed orally during each rTMS Session, before and after each stimulus presentation and cigarette smoking with a brief version of the Shiffman-Jarvik questionnaire (14), which contained items assessing cigarette craving using the following subscale: CRAVING ("urges to smoke," "miss a cigarette," and "crave cigarettes"), MOOD ("calm," "tense," and "irritable"), AROUSAL ("wide awake," "able to concentrate"), and HUNGER ("feel hungry"). The scale for the Shiffman-Jarvik questionnaire is a Likert item scale with measurements 1-Not at All; 2-Very Little; 3-A Little; 4-Moderately; 5- A Lot; 6-Quite A Lot and 7-Extremely. The change in craving for cigarettes after smoking cues versus neutral cues using the parenthetical items listed above with the subscale CRAVING were used to determine the primary outcome. A negative value represents a decrease in reported cigarette craving.
Following exposure to in vivo cues

次要结果测量

结果测量
措施说明
大体时间
Change in Craving for Cigarettes After Controlled Smoke Presentations.
大体时间:After smoking a cigarette through the controlled puff volume apparatus during rTMS
Craving reduction was assessed orally by an item on the cigarette evaluation questionnaire ("Did it immediately reduce your craving for cigarettes?") after smoking presentations through the controlled puff volume apparatus.
After smoking a cigarette through the controlled puff volume apparatus during rTMS

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:Andrew D Krystal, M.D., M.S.、Duke University

出版物和有用的链接

负责输入研究信息的人员自愿提供这些出版物。这些可能与研究有关。

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

2009年5月1日

初级完成 (实际的)

2010年8月1日

研究完成 (实际的)

2010年8月1日

研究注册日期

首次提交

2009年5月11日

首先提交符合 QC 标准的

2009年5月12日

首次发布 (估计)

2009年5月13日

研究记录更新

最后更新发布 (估计)

2013年1月25日

上次提交的符合 QC 标准的更新

2012年12月17日

最后验证

2012年12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.

订阅