Use of SPECT (Single-photon Emission Computed Tomography) to Examine the Role of DAT (Dopamine Transporter) Genotype in Motivated Smoking Behavior

University of Pennsylvania1 site in 1 country14 target enrollmentNovember 2011

ConditionsNicotine Withdrawal

Overview

Phase: Not Applicable
Intervention: Not specified
Conditions: Nicotine Withdrawal
Sponsor: University of Pennsylvania
Enrollment: 14
Locations: 1
Primary Endpoint: SPECT Imaging of DAT Genotype - Difference in TRODAT binding to DAT
Status: Terminated
Last Updated: 10 years ago

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

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

Registry

clinicaltrials.gov

Start Date

November 2011

End Date

October 2014

Last Updated

10 years ago

Study Type

Observational

Sex

All

Investigators

Sponsor

University of Pennsylvania

Responsible Party

Sponsor

Eligibility Criteria

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.