- ICH GCP
- US Clinical Trials Registry
- Klinisk forsøg NCT00135746
Examining the Effectiveness of the Nicotine Patch in Male and Female Smokers - 2
Effects of Transdermal Nicotine on Tobacco Withdrawal and the Effects of Smoking in Men and Women
Studieoversigt
Status
Betingelser
Intervention / Behandling
Detaljeret beskrivelse
Currently, about 70 percent of smokers who try to quit by using smoking cessation treatments are unsuccessful. Treatment studies have demonstrated that current smoking cessation techniques are less effective for women. There is no clear explanation for this difference, but it may involve a differential response to nicotine replacement treatments (NRTs) and/or smoking-related stimuli. For women, NRT may be less effective at suppressing withdrawal or blunting the effects of smoking during a quit attempt. Women may also be more sensitive to smoking-related stimuli, such as the taste, sight, and smell of smoke. Tailoring treatment to the separate needs of subgroups, such as men and women, may produce better outcomes. The purpose of this study is to assess the influence of gender on the effectiveness of transdermal nicotine treatment in a group of male and female smokers.
Participants in this double-blind, dose-comparison study will complete separate sessions in a random order.
Each session will last approximately 6.5 hours and will correspond to a specific transdermal patch dose (0, 7, 14, or 21 mg). Objectively verified cigarette abstinence will be required before each session. Sessions will occur at least 48 hours apart to avoid carryover. Cognitive, behavioral, subjective, and physiological measures will occur during study visits. Specifically, the NRT dose response to tobacco suppression and cigarette blunting effects will be compared in women and men.
Undersøgelsestype
Tilmelding (Forventet)
Fase
- Ikke anvendelig
Kontakter og lokationer
Studiesteder
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-
Virginia
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Richmond, Virginia, Forenede Stater, 23298 0205
- Behavioral Pharmacolgy Research Laboratory
-
-
Deltagelseskriterier
Berettigelseskriterier
Aldre berettiget til at studere
Tager imod sunde frivillige
Køn, der er berettiget til at studere
Beskrivelse
Inclusion Criteria:
- Daily cigarette use of 15 or more cigarettes for at least 2 years
- Screening CO level of or greater than 15 ppm
- Normal or corrected-to-normal vision
- Willing to abstain from tobacco products for 8 or more hours prior to testing
Exclusion Criteria:
- History of chronic health problems or psychiatric conditions
- History of cardiovascular disease, low or high blood pressure, seizures, head injuries requiring hospital care, peptic ulcer, or diabetes
- Pregnancy (tested by urinalysis)
- Scores greater than 17 on the Beck Depression Inventory
- Lack of a high school degree or GED
Studieplan
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
- Primært formål: Behandling
- Interventionel model: Crossover opgave
- Maskning: Dobbelt
Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
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Subjektive effekter
|
Kognitiv præstation
|
Fysiologiske foranstaltninger
|
Rygeadfærd
|
Plasma Nicotine
|
Samarbejdspartnere og efterforskere
Samarbejdspartnere
Efterforskere
- Ledende efterforsker: Thomas Eissenberg, Ph.D., Virginia Commonwealth University
Datoer for undersøgelser
Studer store datoer
Studiestart
Primær færdiggørelse (Faktiske)
Studieafslutning (Faktiske)
Datoer for studieregistrering
Først indsendt
Først indsendt, der opfyldte QC-kriterier
Først opslået (Skøn)
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Skøn)
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
Sidst verificeret
Mere information
Begreber relateret til denne undersøgelse
Nøgleord
Yderligere relevante MeSH-vilkår
- Psykiske lidelser
- Kemisk inducerede lidelser
- Stof-relaterede lidelser
- Tobaksbrugsforstyrrelse
- Lægemidlers fysiologiske virkninger
- Neurotransmittermidler
- Molekylære mekanismer for farmakologisk virkning
- Autonome agenter
- Agenter fra det perifere nervesystem
- Kolinerge midler
- Ganglionstimulerende midler
- Nikotiniske agonister
- Kolinerge agonister
- Nikotin
Andre undersøgelses-id-numre
- NIDA-11082-2
- DPMC (Anden identifikator: NIDA)
- R01-11082-2
Disse oplysninger blev hentet direkte fra webstedet clinicaltrials.gov uden ændringer. Hvis du har nogen anmodninger om at ændre, fjerne eller opdatere dine undersøgelsesoplysninger, bedes du kontakte register@clinicaltrials.gov. Så snart en ændring er implementeret på clinicaltrials.gov, vil denne også blive opdateret automatisk på vores hjemmeside .
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