DDAT: SPECT Imaging of DAT Genotype

Sponsor

University of Pennsylvania (Other)

Overall Status

Terminated

CT.gov ID

NCT01492322

Collaborator

(none)

Enrollment

Location

Duration (Months)

0.4

Patients Per Site Per Month

Study Details

Study Description

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	Phase
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

Study Design

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 :

Nov 1, 2011

Actual Primary Completion Date :

Jul 1, 2013

Actual Study Completion Date :

Oct 1, 2014

Arms and Interventions

Arm	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

Arm

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

Outcome Measures

Primary Outcome Measures

SPECT Imaging of DAT Genotype - Difference in TRODAT binding to DAT [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

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 60 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion Criteria:

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

Exclusion Criteria:

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.).