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Varenicline for Light Smokers (ChanLight)

25. januar 2018 opdateret af: Jon Ebbert, Mayo Clinic
The purpose of this study is to determine if varenicline is effective in treating tobacco dependence in adults who smoke 5-10 cigarettes per day.

Studieoversigt

Status

Afsluttet

Betingelser

Detaljeret beskrivelse

Nearly 50% of U.S. cigarette smokers smoke ≤ 10 cigarettes per day (CPD) and are considered "light smokers." Most light smokers will either maintain a chronic light smoking habit or increase their level of smoking during their lifetime. Importantly, light smokers are at risk for adverse health consequences and increased all-cause mortality. While multiple factors such as reinforcement behavior, diminished autonomy, economic constraints and tobacco control policies influence light smoking, nicotine dependence appears particularly important in 5 to 10 CPD smokers. Despite the high prevalence of light smoking and its increased healthcare burden, few studies have evaluated the efficacy of pharmacotherapy for this group of smokers. Varenicline, which targets symptoms of nicotine dependence, has been shown to increase smoking abstinence rates in moderate to heavy smokers (≥ 10 cigarettes per day). However, varenicline has not been evaluated in subjects who smoke < 10 CPD. In the current proposal we will investigate the efficacy of varenicline for smoking cessation in 5 to 10 CPD light smokers who wish to quit. This study will be conducted as a double-blind, placebo-controlled, randomized clinical trial at the Mayo Clinic, enrolling 224 eligible participants who smoke 5 to 10 CPD. Participants will receive behavior therapy and either varenicline or placebo for 12 weeks with follow up through 26 weeks. We will determine if varenicline increases smoking abstinence in light smokers at end-of-treatment and 26 weeks as compared to placebo.

Undersøgelsestype

Interventionel

Tilmelding (Faktiske)

93

Fase

  • Fase 4

Kontakter og lokationer

Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.

Studiesteder

    • Minnesota
      • Rochester, Minnesota, Forenede Stater, 55905
        • Mayo Clinic

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

18 år og ældre (Voksen, Ældre voksen)

Tager imod sunde frivillige

Ja

Køn, der er berettiget til at studere

Alle

Beskrivelse

Inclusion Criteria:

  1. Subjects must be ≥ 18 years of age;
  2. smokes 5 to 10 CPD for at least 6 months;
  3. express interest in quitting smoking;
  4. indicate ability to complete all study visits; and
  5. provide written informed consent to participate in the study.
  6. Subject is a female subject of non-childbearing potential or a female subject of childbearing potential - who is using contraceptives and has a negative pregnancy test result;
  7. Subject is in good health as determined by the investigator;
  8. Subject has the ability to participate fully in all aspects of the study and keep scheduled appointments.

Exclusion Criteria:

  1. An active medical condition such as unstable angina, myocardial infarction, or coronary angioplasty within the past 3 months or an untreated cardiac dysrhythmia;
  2. History of renal failure;
  3. Cancer [excluding non-melanoma skin cancer] not in remission;
  4. Psychosis or bipolar disorder;
  5. Current unstable or untreated moderate or severe depression as assessed by the CES-D;
  6. have, as defined by the C-SSRS (Columbia-Suicide Severity Rating Scale), current non-specific suicidal thoughts, or have a lifetime history of a suicidal attempt (defined as "potentially self-injurious act committed with at least some wish to die, as a result of act.");
  7. Substance dependence other than nicotine, defined as:

    a. Patient has a recent history (past month) of heavy alcohol consumption as defined by NIAAA: i. Men: More than 4 drinks on any day or 14 per week ii. Women: More than 3 drinks on any day or 7 per week. b. Use of cocaine, heroin, club drugs (i.e., MDMA/"ecstasy"), methamphetamine, or hallucinogens (e.g., LSD) at any time during the past month.

    c. Use of marijuana on a weekly basis for the past month

  8. An allergy to varenicline;
  9. Current use of a behavioral or pharmacologic tobacco dependence treatment and unwilling or unable to discontinue use;
  10. Another member of their household already participating in this study; and
  11. Current treatment with another investigational drug (within 30 days of study entry).
  12. Has an unstable medical condition;
  13. Subject has untreated hypertension or baseline systolic blood pressure > 180 or diastolic > 100;
  14. Women of child-bearing potential, or who are pregnant, lactating or likely to become pregnant during the trial and are unwilling to use an acceptable form of contraception during the medication phase will also be excluded. All female subjects of childbearing potential must have a negative pregnancy test and must agree to use approved contraception during participation in the 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: Parallel tildeling
  • Maskning: Firedobbelt

Våben og indgreb

Deltagergruppe / Arm
Intervention / Behandling
Aktiv komparator: Varenicline
1 mg of varenicline twice per day for 12 weeks.
1 mg of varenicline twice per day for 12 weeks and brief behavioral counseling
Andre navne:
  • chantix
Placebo komparator: placebo
1 placebo tablet twice a day for 12 weeks
1 placebo tablet twice per day for 12 weeks and brief behavioral counseling
Andre navne:
  • sukker pille

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Point Prevalence Smoking Outcome at 12 Weeks (End of Treatment)
Tidsramme: 12 weeks
To determine the efficacy of 12 weeks of varenicline therapy in achieving increased smoking abstinence rates in light smokers. Point prevalence is defined as no smoking in the past 7 days.
12 weeks
Prolonged Smoking Outcome at 12 Weeks (End of Treatment)
Tidsramme: 12 weeks
To determine the efficacy of 12 weeks of varenicline therapy in achieving increased smoking abstinence rates in light smokers. Prolonged abstinence is defined as no smoking since 2 weeks after the target quit date.
12 weeks

Sekundære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Point Prevalence Smoking Outcome at 24 Weeks (End of Study)
Tidsramme: 24 weeks
To determine the efficacy of 12 weeks of varenicline therapy in achieving increased smoking abstinence rates at 6 months in light smokers. Point prevalence is defined as no smoking in the past 7 days.
24 weeks
Prolonged Smoking Outcome at 24 Weeks (End of Study)
Tidsramme: 24 weeks
To determine the efficacy of 12 weeks of varenicline therapy in achieving increased smoking abstinence rates at 6 months in light smokers. Prolonged abstinence is defined as no smoking since 2 weeks after the target quit date.
24 weeks

Samarbejdspartnere og efterforskere

Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.

Sponsor

Samarbejdspartnere

Efterforskere

  • Ledende efterforsker: Ivana T. Croghan, PhD, Mayo Clinic
  • Ledende efterforsker: Jon O. Ebbert, MD, Mayo Clinic

Publikationer og nyttige links

Den person, der er ansvarlig for at indtaste oplysninger om undersøgelsen, leverer frivilligt disse publikationer. Disse kan handle om alt relateret til undersøgelsen.

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 2013

Primær færdiggørelse (Faktiske)

1. december 2015

Studieafslutning (Faktiske)

1. juni 2016

Datoer for studieregistrering

Først indsendt

10. juli 2012

Først indsendt, der opfyldte QC-kriterier

10. juli 2012

Først opslået (Skøn)

12. juli 2012

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Faktiske)

22. februar 2018

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

25. januar 2018

Sidst verificeret

1. januar 2018

Mere information

Begreber relateret til denne undersøgelse

Andre undersøgelses-id-numre

  • 12-005652
  • WS2293926 (Andet bevillings-/finansieringsnummer: Pfizer Inc)

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 .

Kliniske forsøg med Varenicline

3
Abonner