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Genetic Differences in Limbic Activation Associated With Nicotine Withdrawal

2012년 10월 23일 업데이트: M.D. Anderson Cancer Center

Pharmacogenetics, Emotional Reactivity and Smoking Cessation: Genetic Differences in Limbic Activation Associated With Nicotine Withdrawal

Objectives:

  • To evaluate neural correlates associated with emotional processing during nicotine withdrawal preferentially involving the amygdala and associated areas within the corticolimbic and mesolimbic circuitry. We hypothesize that relative to a pre-quit baseline, post-quit nicotine withdrawal will result in increased activity to negative emotional cues, in contrast to other cues, in one or more areas of interest, and particularly in the right cerebral hemisphere.
  • To determine if bupropion and varenicline moderate patterns of brain activation during post-quit nicotine withdrawal. We hypothesize that relative to placebo, bupropion and varenicline will attenuate the effects of post-quit nicotine withdrawal on emotional processing, reducing activation to negative emotional cues, relative to other cues, in one or more areas of interest, and particularly in the right cerebral hemisphere.
  • To determine if genotype (DRD2 TaqA2 allele and the ins variant of the -141C ins/del DRD2) moderates patterns of brain activation during post-quit nicotine withdrawal.

연구 개요

상태

완전한

정황

상세 설명

Before you begin participation in this study, you will be asked to provide the names and addresses of 3 contacts (family member/friends) who will know your current contact information. This is so study researchers can stay in contact with you throughout the study. This is in case study researchers may need to reach you in order to reschedule your appointment time. You will also be asked to sign a letter giving your contacts permission to provide your contact information to the study staff.

If the staff is not able to reach you, they may try to locate you through telephone directory assistance or the internet. If the study staff is still unable to locate you, they may use a locator service, such as Transunion or the National Change of Address (NCOA) database, which is maintained by the United States Postal Service.

If you agree to take part in this study, you will be asked to come to the Behavioral Science Research Clinic at M. D. Anderson for up to 2 laboratory sessions. One session will be while you are smoking, and one session will be while you are abstinent from smoking (not smoking).

At each of these sessions, you will have functional magnetic resonance imaging (fMRI) of your brain while you are looking at slides. fMRI involves a scanner that uses a large magnet, instead of x-rays, to take pictures of the inside of your body. The slides will include pictures of people, nature scenes, artwork, victims of car crashes, medical procedures (such as open surgery or autopsy), and nude people. You will be shown examples of these slides before having the fMRI, and you will be given the opportunity to withdraw from this study at that time. If you choose to continue on this study, you will have an fMRI taken of your brain. This will involve being passed into a narrow tube-shaped scanner that is open at both ends. During the fMRI, your brain electrical activity will be monitored. The total time for each lab session will last about 1.5 hours.

You should not drink more than 2 cups of coffee or other caffeine drinks at least 2 1/2 hours before each session. This is because caffeine may affect brain functioning. Before one or both of your sessions, you may be asked to not smoke from bedtime on the day before the session until after the session on the next day. Before one or both of your sessions, you may be asked to smoke as you would regularly. Additionally, you may be asked to smoke during one or both of your laboratory sessions.

At each lab session, you will be asked to blow air through a carbon monoxide (CO) measuring device. CO is a gas that is found (in higher levels) in the bodies of cigarette smokers. You will also be asked questions about your smoking habits; your health and medical condition; and about any medications you are taking. You will also be asked to complete some questionnaires that will ask about your mood and feelings. You may be asked to complete these questionnaires before, during, or after the fMRI.

At the end of this study, you will be able to ask questions about the results of this study and about procedures you have experienced during this study.

Your participation in this part of the study will last about 2 weeks. It will end after your last lab session. You will still be considered a participant in the main study (Protocol 2003-1024) and may have additional visits, questionnaires, and other activities to complete.

This is an investigational study. Up to 72 participants will take part in this study. All will be enrolled at M. D. Anderson.

연구 유형

중재적

등록 (실제)

64

단계

  • 3단계

연락처 및 위치

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

연구 장소

    • Texas
      • Houston, Texas, 미국, 77030
        • UT MD Anderson Cancer Center

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 이상 (성인, 고령자)

건강한 자원 봉사자를 받아들입니다

아니

연구 대상 성별

모두

설명

Inclusion Criteria:

  1. Subject must be a participant in 'Pharmacogenetics, Emotional Reactivity & Smoking' (protocol 2003-1024).
  2. Both parents must be of European descent. The sample will be limited to individuals of European descent because the majority of the published work on the genes of interest has been limited to this racial group. This has been done mostly to prevent population stratification in genetic studies, since allele frequency differences often exist among groups with differing continents of origin.
  3. Right handed. The sample is limited to right handed individuals since we will analyze our neuroimaging data for lateralization effects and inclusion of participants of mixed handedness could confound the results.
  4. Age: 18 years or older

Exclusion Criteria:

1. Contraindications for MR imaging procedures (e.g., subjects with certain types of implanted medical devices, such as pacemakers, neurostimulators, etc., or subjects who are claustrophobic).

공부 계획

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

연구는 어떻게 설계됩니까?

디자인 세부사항

  • 주 목적: 기초 과학
  • 할당: 해당 없음
  • 중재 모델: 단일 그룹 할당
  • 마스킹: 없음(오픈 라벨)

무기와 개입

참가자 그룹 / 팔
개입 / 치료
다른: fMRI
Functional Magnetic Resonance Imaging (fMRI)
Functional Magnetic Resonance Imaging (fMRI)of the Brain, one session while smoking, and one session while abstinent from smoking (not smoking).

연구는 무엇을 측정합니까?

주요 결과 측정

결과 측정
기간
Stimulus type (positive, negative, neutral, cigarette) by group (Bupropion/ Varenicline/Placebo)
기간: Pre-quit to 1-2 days post-quit
Pre-quit to 1-2 days post-quit

공동 작업자 및 조사자

여기에서 이 연구와 관련된 사람과 조직을 찾을 수 있습니다.

수사관

  • 수석 연구원: Paul Cinciripini, PhD, M.D. Anderson Cancer Center

간행물 및 유용한 링크

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

유용한 링크

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

2008년 4월 1일

기본 완료 (실제)

2012년 10월 1일

연구 등록 날짜

최초 제출

2008년 4월 21일

QC 기준을 충족하는 최초 제출

2008년 4월 22일

처음 게시됨 (추정)

2008년 4월 23일

연구 기록 업데이트

마지막 업데이트 게시됨 (추정)

2012년 10월 24일

QC 기준을 충족하는 마지막 업데이트 제출

2012년 10월 23일

마지막으로 확인됨

2012년 10월 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. .

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