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
  Purpose

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 Intervention Phase
Nicotine Withdrawal
Radiation: TRODAT
Phase 1

Study Type: Observational
Study Design: 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

Resource links provided by NLM:


Further study details as provided by University of Pennsylvania:

Primary Outcome Measures:
  • 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


Estimated Enrollment: 40
Study Start Date: November 2011
Estimated Study Completion Date: December 2013
Estimated Primary Completion Date: December 2013 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
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

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

  Eligibility

Ages Eligible for Study:   18 Years to 60 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

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.

Criteria

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.).
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01492322

Contacts
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

Locations
United States, Pennsylvania
University of Pennsylvania Addiction Treatment Research Center Recruiting
Philadelphia, Pennsylvania, United States, 19104
Sponsors and Collaborators
University of Pennsylvania
Investigators
Principal Investigator: Teresa Franklin, PhD University of Pennsylvania
  More Information

No publications provided

Responsible Party: University of Pennsylvania
ClinicalTrials.gov Identifier: NCT01492322     History of Changes
Other Study ID Numbers: 813475
Study First Received: December 2, 2011
Last Updated: December 12, 2011
Health Authority: United States: Food and Drug Administration

Keywords provided by University of Pennsylvania:
Smoker
SPECT
Dopamine
Nicotine Sated condition
Nicotine withdrawal condition

Additional relevant MeSH terms:
Substance Withdrawal Syndrome
Substance-Related Disorders
Chemically-Induced Disorders
Mental Disorders

ClinicalTrials.gov processed this record on September 22, 2014