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SPECT Imaging of DAT Genotype (DDAT)

2015年10月7日 更新者:University of Pennsylvania

Use of SPECT (Single-photon Emission Computed Tomography) to Examine the Role of DAT (Dopamine Transporter) Genotype in Motivated Smoking Behavior

A polymorphism in the dopamine transporter (DAT) may determine how much dopamine is available at the synapse and this may affect the underlying reasons for relapse in smokers. This research will use Single-photon emission computed tomography SPECT and the DAT-specific ligand, TRODAT (Dopamine Transporter Density by [99mTc]), to examine the availability of DAT in smokers grouped by genotype in the sated (just having smoked) and withdrawal (4 hours without smoking) conditions.

研究概览

地位

终止

干预/治疗

详细说明

There will be 2 SPECT scans for each smoker who participates in this research. One SPECT scan when the smoker is sated with nicotine and one where the smoker is in withdrawal

研究类型

观察性的

注册 (实际的)

14

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

    • Pennsylvania
      • Philadelphia、Pennsylvania、美国、19104
        • University of Pennsylvania Addiction Treatment Research Center

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 60年 (成人)

接受健康志愿者

有资格学习的性别

全部

取样方法

非概率样本

研究人群

Subjects will be forty physically-healthy and mentally-stable male and non-pregnant female subjects between the ages of 18 and 60 who meet the DSM-IV criteria for nicotine dependence. Subjects will not be excluded based on gender, religion, race, or socioeconomic status. The subject population of previous smoking studies in our lab was 54% female, 62% Caucasian, and averaged 15 years of education. This is representative of the urban population in the northeast region of the United States who seek help for nicotine dependence. We expect our current population to have similar characteristics.

描述

Inclusion Criteria:

  1. Physically healthy male or female nicotine dependent patients ages 18-60 without other current drug dependence (excluding marijuana) or psychiatric diagnosis.
  2. Smoke at least 10 cigarettes per day for at least 6 months prior to study start date.
  3. Females must be non-pregnant, non-lactating and either be of non-childbearing potential (i.e. sterilized via hysterectomy or bilateral tubal ligation or at least 1 year post-menopausal) or of child bearing potential, but practicing a medically acceptable method of birth control from at least 48 hours prior to SPECT imaging until 30 days following the scan. Examples of medically acceptable methods for this protocol include barrier (diaphragm or condom) with spermicide, an intrauterine device (IUD), oral contraceptives, levonorgestrel implant, or complete abstinence.
  4. Subjects provide voluntary informed consent.
  5. Subjects must read on 8th grade (or above) level.
  6. Not using other methods for smoking cessation

Exclusion Criteria:

  1. Participation in clinical trial and receipt of investigational drug(s) during previous 60 days
  2. History of head trauma or injury causing loss of consciousness, lasting more than three (3) minutes or associated with skull fracture or inter-cranial bleeding or abnormal MRI.
  3. HIV positive on medication for symptoms. This will be determined on an individual basis by results from the physical examination and final approval by our study physician.
  4. Symptomatic presence of other hematological disease.
  5. Clinically significant cardiovascular, hepatic (liver), renal (kidney), neurological, or endocrinological (including Type II diabetes) abnormalities.
  6. Asthmatic condition which requires the use of an inhaler more than twice per week
  7. History of psychosis, seizures, or organic brain syndrome.
  8. Use of medications or natural herbs that may cause sedation or may effect the brain systems that are being studied (medication use will be evaluated by our study physician on a case-by-case basis).
  9. Claustrophobia, trypanophobia (needle phobia) or other medical condition preventing subject from lying in the SPECT scanner for approximately one (1) hour.
  10. Individuals with an intelligence quotient of 80 or less.
  11. Smoke non-filtered cigarettes
  12. Treatment for alcohol or drug dependence within the last 3 months
  13. A significant alcohol or drug use history (multiple treatments, 5 years of dependence, positive urines, etc.).

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

队列和干预

团体/队列
干预/治疗
Sated and withdrawal group
To determine differences in TRODAT binding to the DAT between a smoker when sated and when in withdrawal
Smoker will receive a TRODAT injection

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
SPECT Imaging of DAT Genotype - Difference in TRODAT binding to DAT
大体时间:Up to 3 years for data analyses
To determine differences in TRODAT binding to the DAT between smokers who are sated and those who are in withdrawal
Up to 3 years for data analyses

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:Teresa Franklin, PhD、University of Pennsylvania

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

2011年11月1日

初级完成 (实际的)

2013年7月1日

研究完成 (实际的)

2014年10月1日

研究注册日期

首次提交

2011年12月2日

首先提交符合 QC 标准的

2011年12月12日

首次发布 (估计)

2011年12月14日

研究记录更新

最后更新发布 (估计)

2015年10月12日

上次提交的符合 QC 标准的更新

2015年10月7日

最后验证

2011年12月1日

更多信息

与本研究相关的术语

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.

TRODAT的临床试验

3
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