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SPECT Imaging of DAT Genotype (DDAT)

The recruitment status of this study is unknown because the information has not been verified recently.
Verified December 2011 by University of Pennsylvania.
Recruitment status was  Recruiting
Sponsor:
Information provided by (Responsible Party):
University of Pennsylvania
ClinicalTrials.gov Identifier:
NCT01492322
First received: December 2, 2011
Last updated: December 12, 2011
Last verified: December 2011

December 2, 2011
December 12, 2011
November 2011
December 2013   (final data collection date for primary outcome measure)
SPECT Imaging of DAT Genotype - Difference in TRODAT binding to DAT [ Time Frame: Up to 3 years for data analyses ] [ Designated as safety issue: No ]
To determine differences in TRODAT binding to the DAT between smokers who are sated and those who are in withdrawal
Same as current
Complete list of historical versions of study NCT01492322 on ClinicalTrials.gov Archive Site
Not Provided
Not Provided
Not Provided
Not Provided
 
SPECT Imaging of DAT Genotype
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.

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

Observational
Observational Model: Cohort
Not Provided
Not Provided
Non-Probability Sample

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.

Nicotine Withdrawal
Radiation: TRODAT
Smoker will receive a TRODAT injection
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
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
40
December 2013
December 2013   (final data collection date for primary outcome measure)

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.).
Both
18 Years to 60 Years
No
Contact: Julian Bender, BA 215-222-3200 ext 188 Bender_j@mail.trc.upenn.edu
Contact: Joshua Shin, BS 215-222-3200 ext 199 Shin_j@mail.trc.upenn.edu
United States
 
NCT01492322
813475
No
University of Pennsylvania
University of Pennsylvania
Not Provided
Principal Investigator: Teresa Franklin, PhD University of Pennsylvania
University of Pennsylvania
December 2011

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP