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Trial record 2 of 8 for:    nicotine | Alzheimer Disease

SPECT Imaging of DAT Genotype (DDAT)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01492322
Recruitment Status : Terminated (UPenn suspended production of the ligand necessary to produce the tracer TRODAT.)
First Posted : December 14, 2011
Last Update Posted : October 12, 2015
Information provided by (Responsible Party):
University of Pennsylvania

Brief Summary:
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.

Condition or disease Intervention/treatment
Nicotine Withdrawal Radiation: TRODAT

Detailed Description:
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

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Study Type : Observational
Actual Enrollment : 14 participants
Observational Model: Cohort
Official Title: Use of SPECT (Single-photon Emission Computed Tomography) to Examine the Role of DAT (Dopamine Transporter) Genotype in Motivated Smoking Behavior
Study Start Date : November 2011
Actual Primary Completion Date : July 2013
Actual Study Completion Date : October 2014

Resource links provided by the National Library of Medicine

Group/Cohort Intervention/treatment
Sated and withdrawal group
To determine differences in TRODAT binding to the DAT between a smoker when sated and when in withdrawal
Radiation: TRODAT
Smoker will receive a TRODAT injection

Primary Outcome Measures :
  1. SPECT Imaging of DAT Genotype - Difference in TRODAT binding to DAT [ Time Frame: 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

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 60 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
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.

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.).

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01492322

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United States, Pennsylvania
University of Pennsylvania Addiction Treatment Research Center
Philadelphia, Pennsylvania, United States, 19104
Sponsors and Collaborators
University of Pennsylvania
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Principal Investigator: Teresa Franklin, PhD University of Pennsylvania

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Responsible Party: University of Pennsylvania Identifier: NCT01492322    
Other Study ID Numbers: 813475
First Posted: December 14, 2011    Key Record Dates
Last Update Posted: October 12, 2015
Last Verified: December 2011
Keywords provided by University of Pennsylvania:
Nicotine Sated condition
Nicotine withdrawal condition
Additional relevant MeSH terms:
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Substance-Related Disorders
Chemically-Induced Disorders
Mental Disorders
Substance Withdrawal Syndrome
Ganglionic Stimulants
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Nicotinic Agonists
Cholinergic Agonists
Cholinergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Cardiotonic Agents
Dopamine Agents
Protective Agents