- ICH GCP
- US Clinical Trials Registry
- Klinisk utprøving NCT01492322
SPECT Imaging of DAT Genotype (DDAT)
7. oktober 2015 oppdatert av: University of Pennsylvania
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.
Studieoversikt
Detaljert beskrivelse
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
Studietype
Observasjonsmessig
Registrering (Faktiske)
14
Kontakter og plasseringer
Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.
Studiesteder
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Pennsylvania
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Philadelphia, Pennsylvania, Forente stater, 19104
- University of Pennsylvania Addiction Treatment Research Center
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Deltakelseskriterier
Forskere ser etter personer som passer til en bestemt beskrivelse, kalt kvalifikasjonskriterier. Noen eksempler på disse kriteriene er en persons generelle helsetilstand eller tidligere behandlinger.
Kvalifikasjonskriterier
Alder som er kvalifisert for studier
18 år til 60 år (Voksen)
Tar imot friske frivillige
Nei
Kjønn som er kvalifisert for studier
Alle
Prøvetakingsmetode
Ikke-sannsynlighetsprøve
Studiepopulasjon
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.
Beskrivelse
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.).
Studieplan
Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.
Hvordan er studiet utformet?
Designdetaljer
Kohorter og intervensjoner
Gruppe / Kohort |
Intervensjon / Behandling |
|---|---|
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Sated and withdrawal group
To determine differences in TRODAT binding to the DAT between a smoker when sated and when in withdrawal
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Smoker will receive a TRODAT injection
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Hva måler studien?
Primære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
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SPECT Imaging of DAT Genotype - Difference in TRODAT binding to DAT
Tidsramme: Up to 3 years for data analyses
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To determine differences in TRODAT binding to the DAT between smokers who are sated and those who are in withdrawal
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Up to 3 years for data analyses
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Samarbeidspartnere og etterforskere
Det er her du vil finne personer og organisasjoner som er involvert i denne studien.
Sponsor
Etterforskere
- Hovedetterforsker: Teresa Franklin, PhD, University of Pennsylvania
Studierekorddatoer
Disse datoene sporer fremdriften for innsending av studieposter og sammendragsresultater til ClinicalTrials.gov. Studieposter og rapporterte resultater gjennomgås av National Library of Medicine (NLM) for å sikre at de oppfyller spesifikke kvalitetskontrollstandarder før de legges ut på det offentlige nettstedet.
Studer hoveddatoer
Studiestart
1. november 2011
Primær fullføring (Faktiske)
1. juli 2013
Studiet fullført (Faktiske)
1. oktober 2014
Datoer for studieregistrering
Først innsendt
2. desember 2011
Først innsendt som oppfylte QC-kriteriene
12. desember 2011
Først lagt ut (Anslag)
14. desember 2011
Oppdateringer av studieposter
Sist oppdatering lagt ut (Anslag)
12. oktober 2015
Siste oppdatering sendt inn som oppfylte QC-kriteriene
7. oktober 2015
Sist bekreftet
1. desember 2011
Mer informasjon
Begreper knyttet til denne studien
Ytterligere relevante MeSH-vilkår
Andre studie-ID-numre
- 813475
Denne informasjonen ble hentet direkte fra nettstedet clinicaltrials.gov uten noen endringer. Hvis du har noen forespørsler om å endre, fjerne eller oppdatere studiedetaljene dine, vennligst kontakt register@clinicaltrials.gov. Så snart en endring er implementert på clinicaltrials.gov, vil denne også bli oppdatert automatisk på nettstedet vårt. .