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Trial record 2 of 8 for:    nicotine | Alzheimer Disease

SPECT Imaging of DAT Genotype (DDAT)

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ClinicalTrials.gov 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
Sponsor:
Information provided by (Responsible Party):
University of Pennsylvania

Tracking Information
First Submitted Date December 2, 2011
First Posted Date December 14, 2011
Last Update Posted Date October 12, 2015
Study Start Date November 2011
Actual Primary Completion Date July 2013   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: December 12, 2011)
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
Original Primary Outcome Measures Same as current
Change History Complete list of historical versions of study NCT01492322 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures Not Provided
Original Secondary Outcome Measures Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title SPECT Imaging of DAT Genotype
Official Title Use of SPECT (Single-photon Emission Computed Tomography) to Examine the Role of DAT (Dopamine Transporter) Genotype in Motivated Smoking Behavior
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.
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
Study Type Observational
Study Design Observational Model: Cohort
Target Follow-Up Duration Not Provided
Biospecimen Not Provided
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.
Condition Nicotine Withdrawal
Intervention Radiation: TRODAT
Smoker will receive a TRODAT injection
Study Groups/Cohorts Sated and withdrawal group
To determine differences in TRODAT binding to the DAT between a smoker when sated and when in withdrawal
Intervention: Radiation: TRODAT
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Terminated
Actual Enrollment
 (submitted: October 7, 2015)
14
Original Estimated Enrollment
 (submitted: December 12, 2011)
40
Actual Study Completion Date October 2014
Actual Primary Completion Date July 2013   (Final data collection date for primary outcome measure)
Eligibility Criteria

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.).
Sex/Gender
Sexes Eligible for Study: All
Ages 18 Years to 60 Years   (Adult)
Accepts Healthy Volunteers No
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries United States
Removed Location Countries  
 
Administrative Information
NCT Number NCT01492322
Other Study ID Numbers 813475
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement Not Provided
Responsible Party University of Pennsylvania
Study Sponsor University of Pennsylvania
Collaborators Not Provided
Investigators
Principal Investigator: Teresa Franklin, PhD University of Pennsylvania
PRS Account University of Pennsylvania
Verification Date December 2011