- ICH GCP
- US Clinical Trials Registry
- Klinisk forsøg NCT00699556
Do Treatments for Smoking Cessation Affect Alcohol Drinking? Study 1: Nicotine Replacement Therapy
12. februar 2018 opdateret af: Sherry McKee, Yale University
This study examines the effect of combined nicotine replacement therapy (transdermal patch + nasal spray vs. transdermal patch + placebo nasal spray) on reactivity to alcohol and self-administration behavior.
Studieoversigt
Status
Afsluttet
Betingelser
Undersøgelsestype
Interventionel
Tilmelding (Faktiske)
22
Fase
- Fase 2
Kontakter og lokationer
Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.
Studiesteder
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Connecticut
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New Haven, Connecticut, Forenede Stater, 06519
- Connecticut Mental Health Center & Yale-New Haven Hospital
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Deltagelseskriterier
Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.
Berettigelseskriterier
Aldre berettiget til at studere
21 år og ældre (Voksen, Ældre voksen)
Tager imod sunde frivillige
Ingen
Køn, der er berettiget til at studere
Alle
Beskrivelse
Inclusion Criteria:
- Ages 21 and over
- Able to read and write in English
- Smoker
- Heavy drinker
Exclusion Criteria:
- Any significant current medical or psychiatric conditions that would contraindicate the consumption of alcohol or nicotine
- Significant hepatocellular injury
- Positive test result at intake appointments on urine drug screens conducted for opiates, cocaine, or benzodiazepines
- Women who are pregnant or nursing
- Suicidal, homicidal, or evidence of severe mental illness
- Prescription of any psychotropic drug in the 30 days prior to study enrollment
- Blood donation within the past 8 weeks
- Individuals who are seeking treatment for drinking or smoking who have attempted to quit drinking or smoking within the past 3 months
- Specific exclusions for administration of nicotine nasal spray not specified above including nasal polyps, chronic nasal congestion, allergies, sinusitis
- Specific exclusions for administration of nicotine patch not specified above including history of dermatoses
- Reported sensitivity or allergies to pepper or pepper spray, peppermint, or prior adverse reaction to nicotine spray
- Participation within the past 8 weeks in other studies that involve additive blood sampling and/or interventional measures that would be considered excessive in combination with the current study
Studieplan
Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
- Primært formål: Behandling
- Tildeling: Randomiseret
- Interventionel model: Crossover opgave
- Maskning: Tredobbelt
Våben og indgreb
Deltagergruppe / Arm |
Intervention / Behandling |
---|---|
Eksperimentel: patch+spray
Within subject design.
All volunteers complete two laboratory sessions.
In one session they receive nicotine patch + nicotine nasal spray.
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21mg transdermal nicotine patch
Andre navne:
two 0.5mg/sprays, one to each nostril (dose = 1mg) The nicotine nasal spray is formulated by the Investigational Drug Service at Yale-New Haven Hospital.
It is similar in concentration to Nicotrol.
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Placebo komparator: patch+placebo spray
Within subject design.
All volunteers complete two laboratory sessions.
In one session they receive nicotine patch + placebo nicotine nasal spray.
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21mg transdermal nicotine patch
Andre navne:
saline combined with capsaicin to mimic the brief nasal irritation from active nicotine spray The placebo nasal spray is formulated by the Investigational Drug Service at Yale-New Haven Hospital.
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Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
---|---|---|
Number of Drinks Consumed During an Ad-libitum Drinking Period
Tidsramme: Two hour ad-libitum drinking period during laboratory session
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Participants are presented with alcohol beverages and allowed to drink at their leisure.
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Two hour ad-libitum drinking period during laboratory session
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Sekundære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
---|---|---|
Craving for Alcohol
Tidsramme: first measurement during laboratory session (+60 minutes after beginning of laboratory session)
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Alcohol craving was measured using the Alcohol Urge Questionnaire (AUQ).
The range of scores is 1-100 on a visual analog scale (VAS).
Higher scores indicate higher levels of craving.
Score indicated is the total score.
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first measurement during laboratory session (+60 minutes after beginning of laboratory session)
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Samarbejdspartnere og efterforskere
Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.
Sponsor
Samarbejdspartnere
Datoer for undersøgelser
Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.
Studer store datoer
Studiestart
1. januar 2006
Primær færdiggørelse (Faktiske)
1. november 2016
Studieafslutning (Faktiske)
1. november 2016
Datoer for studieregistrering
Først indsendt
25. december 2007
Først indsendt, der opfyldte QC-kriterier
13. juni 2008
Først opslået (Skøn)
18. juni 2008
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Faktiske)
12. marts 2018
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
12. februar 2018
Sidst verificeret
1. februar 2018
Mere information
Begreber relateret til denne undersøgelse
Nøgleord
Yderligere relevante MeSH-vilkår
Andre undersøgelses-id-numre
- HIC0508000486
- R01AA015596 (U.S. NIH-bevilling/kontrakt)
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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