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
Information provided by (Responsible Party):
University of Pennsylvania
First received: December 2, 2011
Last updated: December 12, 2011
Last verified: December 2011
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.
||Observational Model: Cohort
||Use of SPECT (Single-photon Emission Computed Tomography) to Examine the Role of DAT (Dopamine Transporter) Genotype in Motivated Smoking Behavior
Primary Outcome Measures:
| Estimated Enrollment:
| Study Start Date:
| Estimated Study Completion Date:
| Estimated Primary Completion Date:
||December 2013 (Final data collection date for primary outcome measure)
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
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
|Ages Eligible for Study:
||18 Years to 60 Years
|Genders Eligible for Study:
|Accepts Healthy Volunteers:
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.
- Physically healthy male or female nicotine dependent patients ages 18-60 without other current drug dependence (excluding marijuana) or psychiatric diagnosis.
- Smoke at least 10 cigarettes per day for at least 6 months prior to study start date.
- 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.
- Subjects provide voluntary informed consent.
- Subjects must read on 8th grade (or above) level.
- Not using other methods for smoking cessation
- Participation in clinical trial and receipt of investigational drug(s) during previous 60 days
- 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.
- 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.
- Symptomatic presence of other hematological disease.
- Clinically significant cardiovascular, hepatic (liver), renal (kidney), neurological, or endocrinological (including Type II diabetes) abnormalities.
- Asthmatic condition which requires the use of an inhaler more than twice per week
- History of psychosis, seizures, or organic brain syndrome.
- 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).
- Claustrophobia, trypanophobia (needle phobia) or other medical condition preventing subject from lying in the SPECT scanner for approximately one (1) hour.
- Individuals with an intelligence quotient of 80 or less.
- Smoke non-filtered cigarettes
- Treatment for alcohol or drug dependence within the last 3 months
- A significant alcohol or drug use history (multiple treatments, 5 years of dependence, positive urines, etc.).
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Please refer to this study by its ClinicalTrials.gov identifier: NCT01492322
|University of Pennsylvania Addiction Treatment Research Center
|Philadelphia, Pennsylvania, United States, 19104 |
University of Pennsylvania
||Teresa Franklin, PhD
||University of Pennsylvania
No publications provided
||University of Pennsylvania
History of Changes
|Other Study ID Numbers:
|Study First Received:
||December 2, 2011
||December 12, 2011
||United States: Food and Drug Administration
Keywords provided by University of Pennsylvania:
Nicotine Sated condition
Nicotine withdrawal condition
Additional relevant MeSH terms:
ClinicalTrials.gov processed this record on October 23, 2014
Substance Withdrawal Syndrome