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

2012년 12월 17일 업데이트: 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.

연구 개요

상세 설명

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

연구 유형

중재적

등록 (실제)

21

단계

  • 2 단계

연락처 및 위치

이 섹션에서는 연구를 수행하는 사람들의 연락처 정보와 이 연구가 수행되는 장소에 대한 정보를 제공합니다.

연구 장소

    • North Carolina
      • Durham, North Carolina, 미국, 27705
        • Duke Center for Nicotine & Smoking Cessation Research

참여기준

연구원은 적격성 기준이라는 특정 설명에 맞는 사람을 찾습니다. 이러한 기준의 몇 가지 예는 개인의 일반적인 건강 상태 또는 이전 치료입니다.

자격 기준

공부할 수 있는 나이

18년 (성인)

건강한 자원 봉사자를 받아들입니다

아니

연구 대상 성별

모두

설명

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.

공부 계획

이 섹션에서는 연구 설계 방법과 연구가 측정하는 내용을 포함하여 연구 계획에 대한 세부 정보를 제공합니다.

연구는 어떻게 설계됩니까?

디자인 세부사항

  • 주 목적: 치료
  • 할당: 무작위
  • 중재 모델: 크로스오버 할당
  • 마스킹: 하나의

무기와 개입

참가자 그룹 / 팔
개입 / 치료
활성 비교기: 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.
활성 비교기: 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.
활성 비교기: 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.

연구는 무엇을 측정합니까?

주요 결과 측정

결과 측정
측정값 설명
기간
Change in Craving for Cigarettes After Smoking Cues Versus Neutral Cues Using a Repeated Measure Design.
기간: 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

2차 결과 측정

결과 측정
측정값 설명
기간
Change in Craving for Cigarettes After Controlled Smoke Presentations.
기간: 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

공동 작업자 및 조사자

여기에서 이 연구와 관련된 사람과 조직을 찾을 수 있습니다.

스폰서

수사관

  • 수석 연구원: Andrew D Krystal, M.D., M.S., Duke University

간행물 및 유용한 링크

연구에 대한 정보 입력을 담당하는 사람이 자발적으로 이러한 간행물을 제공합니다. 이것은 연구와 관련된 모든 것에 관한 것일 수 있습니다.

연구 기록 날짜

이 날짜는 ClinicalTrials.gov에 대한 연구 기록 및 요약 결과 제출의 진행 상황을 추적합니다. 연구 기록 및 보고된 결과는 공개 웹사이트에 게시되기 전에 특정 품질 관리 기준을 충족하는지 확인하기 위해 국립 의학 도서관(NLM)에서 검토합니다.

연구 주요 날짜

연구 시작

2009년 5월 1일

기본 완료 (실제)

2010년 8월 1일

연구 완료 (실제)

2010년 8월 1일

연구 등록 날짜

최초 제출

2009년 5월 11일

QC 기준을 충족하는 최초 제출

2009년 5월 12일

처음 게시됨 (추정)

2009년 5월 13일

연구 기록 업데이트

마지막 업데이트 게시됨 (추정)

2013년 1월 25일

QC 기준을 충족하는 마지막 업데이트 제출

2012년 12월 17일

마지막으로 확인됨

2012년 12월 1일

추가 정보

이 정보는 변경 없이 clinicaltrials.gov 웹사이트에서 직접 가져온 것입니다. 귀하의 연구 세부 정보를 변경, 제거 또는 업데이트하도록 요청하는 경우 register@clinicaltrials.gov. 문의하십시오. 변경 사항이 clinicaltrials.gov에 구현되는 즉시 저희 웹사이트에도 자동으로 업데이트됩니다. .

Active rTMS Condition에 대한 임상 시험

구독하다