SPECT Imaging of DAT Genotype



Status:Terminated
Conditions:Smoking Cessation, Psychiatric
Therapuetic Areas:Psychiatry / Psychology, Pulmonary / Respiratory Diseases
Healthy:No
Age Range:18 - 60
Updated:4/21/2016
Start Date:November 2011
End Date:October 2014

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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

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.).
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