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Comparison of Nicotine Inhaler and/or Bupropion in Helping People to Stop Smoking and Prevent the Recurrence of Smoking

12 juli 2016 uppdaterad av: Alliance for Clinical Trials in Oncology

Phase III Trial Comparing Nicotine Inhaler Versus Bupropion Versus Nicotine Inhaler Plus Bupropion For Smoking Cessation Efficacy And Relapse Prevention

RATIONALE: Use of a nicotine inhaler and/or bupropion may be effective in helping people stop smoking and prevent them from starting smoking again. It is not yet known whether a nicotine inhaler or bupropion are more effective alone or combined for stopping smoking.

PURPOSE: Randomized phase III trial to compare the effectiveness of the nicotine inhaler or bupropion alone to that of the nicotine inhaler combined with bupropion in helping people to stop smoking and prevent starting smoking again.

Studieöversikt

Status

Avslutad

Betingelser

Intervention / Behandling

Detaljerad beskrivning

OBJECTIVES: I. Compare the effectiveness of nicotine inhaler vs bupropion vs nicotine inhaler plus bupropion on smoking cessation and prevention of relapse in participants who currently smoke. II. Compare the reduction in the rate of relapse to smoking after initial abstinence in participants treated long term with these regimens.

OUTLINE: This is a randomized, double-blind, placebo-controlled, multicenter study. Patients are stratified according to gender, cigarettes smoked per day at time of screening (10-39 vs 40 or more), and total length of smoking in years (less than 5 vs 5-9 vs 10 or more). Participants are randomized to one of three treatment arms. Arm I: Participants receive 6-16 nicotine inhaler cartridges per day. Arm II: Participants receive oral bupropion 1-2 times daily. Arm III: Participants receive 6-16 nicotine inhaler cartridges per day and oral bupropion 1-2 times daily. In all arms, treatment continues for 12 weeks. After 12 weeks, participants are randomized a second time based on whether they continue to smoke or are smoke-free. Participants randomized to arm I who continue to smoke are randomized to one of two treatment arms. Arm IV: Participants receive oral bupropion 1-2 times daily for 12 weeks Arm V: Participants receive oral placebo 1-2 times daily for 12 weeks. Participants randomized to arm II who continue to smoke are randomized to one of two treatment arms. Arm VI: Participants receive 6-16 nicotine inhaler cartridges per day for 12 weeks. Arm VII: Participants receive 6-16 placebo inhaler cartridges per day for 12 weeks. Participants randomized to arm III who continue to smoke do not receive any further therapy. Participants randomized to arm I who are smoke-free are randomized to one of two treatment arms. Arm VIII: Participants receive 6-16 nicotine inhaler cartridges per day for 40 weeks. Arm IX: Participants receive 6-16 placebo inhaler cartridges per day for 40 weeks. Participants randomized to arm II who are smoke-free are randomized to one of two treatment arms. Arm X: Participants receive oral bupropion 1-2 times daily for 40 weeks. Arm XI: Participants receive oral placebo 1-2 times daily for 40 weeks. Participants randomized to arm III who are smoke-free are randomized to one of four treatment arms. Arm XII: Participants receive 6-16 nicotine inhaler cartridges per day and oral placebo 1-2 times daily for 40 weeks. Arm XIII: Participants receive 6-16 placebo inhaler cartridges per day and oral bupropion 1-2 times daily for 40 weeks. Arm XIV: Participants receive 6-16 nicotine inhaler cartridges per day and oral bupropion 1-2 times daily for 40 weeks. Arm XV: Participants receive 6-16 placebo inhaler cartridges per day and oral placebo 1-2 times daily for 40 weeks. All participants are followed every month for 6 months.

Studietyp

Interventionell

Inskrivning (Faktisk)

1708

Fas

  • Fas 3

Kontakter och platser

Det här avsnittet innehåller kontaktuppgifter för dem som genomför studien och information om var denna studie genomförs.

Studieorter

  • Förenta staterna
    • Arizona
      • Scottsdale, Arizona, Förenta staterna, 85259-5404
        • CCOP - Scottsdale Oncology Program
    • District of Columbia
      • Washington, District of Columbia, Förenta staterna, 20060
        • MBCCOP-Howard University Cancer Center
    • Illinois
      • Peoria, Illinois, Förenta staterna, 61602
        • CCOP - Illinois Oncology Research Association
      • Urbana, Illinois, Förenta staterna, 61801
        • CCOP - Carle Cancer Center
    • Iowa
      • Cedar Rapids, Iowa, Förenta staterna, 52403-1206
        • CCOP - Cedar Rapids Oncology Project
      • Des Moines, Iowa, Förenta staterna, 50309-1016
        • CCOP - Iowa Oncology Research Association
      • Sioux City, Iowa, Förenta staterna, 51101-1733
        • Siouxland Hematology-Oncology
    • Kansas
      • Wichita, Kansas, Förenta staterna, 67214
        • Cancer Center of Kansas - Wichita
      • Wichita, Kansas, Förenta staterna, 67214-3882
        • CCOP - Wichita
    • Louisiana
      • New Orleans, Louisiana, Förenta staterna, 70121
        • CCOP - Ochsner
    • Michigan
      • Ann Arbor, Michigan, Förenta staterna, 48106
        • CCOP - Ann Arbor Regional
    • Minnesota
      • Duluth, Minnesota, Förenta staterna, 55805
        • CCOP - Duluth
      • Rochester, Minnesota, Förenta staterna, 55905
        • Mayo Clinic Cancer Center
      • Saint Cloud, Minnesota, Förenta staterna, 56303
        • CentraCare Clinic
      • Saint Louis Park, Minnesota, Förenta staterna, 55416
        • CCOP - Metro-Minnesota
    • Nebraska
      • Omaha, Nebraska, Förenta staterna, 68131
        • CCOP - Missouri Valley Cancer Consortium
    • North Dakota
      • Bismarck, North Dakota, Förenta staterna, 58501
        • Medcenter One Health System
      • Fargo, North Dakota, Förenta staterna, 58122
        • CCOP - Merit Care Hospital
      • Grand Forks, North Dakota, Förenta staterna, 58201
        • Altru Health Systems
    • Ohio
      • Toledo, Ohio, Förenta staterna, 43623-3456
        • CCOP - Toledo Community Hospital Oncology Program
    • Oklahoma
      • Tulsa, Oklahoma, Förenta staterna, 74136
        • CCOP - Sooner State
    • Pennsylvania
      • Danville, Pennsylvania, Förenta staterna, 17822-2001
        • CCOP - Geisinger Clinic and Medical Center
    • South Dakota
      • Rapid City, South Dakota, Förenta staterna, 57709
        • Rapid City Regional Hospital
      • Sioux Falls, South Dakota, Förenta staterna, 57104
        • CCOP - Sioux Community Cancer Consortium
  • Kanada
    • Saskatchewan
      • Regina, Saskatchewan, Kanada, S4T 7T1
        • Allan Blair Cancer Centre

Deltagandekriterier

Forskare letar efter personer som passar en viss beskrivning, så kallade behörighetskriterier. Några exempel på dessa kriterier är en persons allmänna hälsotillstånd eller tidigare behandlingar.

Urvalskriterier

Åldrar som är berättigade till studier

18 år och äldre (Vuxen, Äldre vuxen)

Tar emot friska volontärer

Nej

Kön som är behöriga för studier

Allt

Beskrivning

DISEASE CHARACTERISTICS: Currently smoking at least 10 cigarettes per day Smoked regularly for the past year Motivated to use study medication More than 30 days since prior use of tobacco products other than cigarettes (e.g., smokeless tobacco, pipes, cigars, or snuff) No active chemical dependence of drug other than nicotine (e.g., alcohol, marijuana, cocaine, heroin, or other illicit drugs) within the past year

PATIENT CHARACTERISTICS: Age: 18 and over Performance status: Not specified Life expectancy: Not specified Hematopoietic: Not specified Hepatic: Not specified Renal: Not specified Cardiovascular: No unstable angina, myocardial infarction, or cardiac arrhythmias within the past 3 months Other: Not pregnant or nursing Negative pregnancy test Fertile patients must use effective contraception for at least 3 months prior to and during study Good health by medical history No history of seizure disorder No epilepsy No prior serious head trauma or other predisposing factors to seizures (e.g., alcohol withdrawal, febrile seizures during childhood, brain tumor, cerebrovascular accident, or family history of idiopathic seizure disorder) No known hypersensitivity or allergy to nicotine, menthol, or bupropion No prior or concurrent diagnosis of bulimia or anorexia nervosa No other member of household currently enrolled on this study No bipolar disorder, psychosis, or schizophrenia

PRIOR CONCURRENT THERAPY: Biologic therapy: Not specified Chemotherapy: Not specified Endocrine therapy: More than 30 days since prior systemic steroids Radiotherapy: Not specified Surgery: Not specified Other: More than 30 days since other prior behavioral or pharmacologic smoking- cessation program (e.g., behavioral therapy, nicotine replacement therapy, clonidine, bupropion, nortriptyline, or doxepin) More than 30 days since prior investigational drugs More than 30 days since prior antipsychotics or antidepressants More than 30 days since prior theophylline More than 30 days since prior monoamine oxidase inhibitor More than 30 days since prior medication containing bupropion No concurrent antiepileptic medications No concurrent medications known to lower seizure threshold No other concurrent investigational drugs

Studieplan

Det här avsnittet ger detaljer om studieplanen, inklusive hur studien är utformad och vad studien mäter.

Hur är studien utformad?

Designdetaljer

  • Primärt syfte: Förebyggande
  • Tilldelning: Randomiserad
  • Interventionsmodell: Crossover tilldelning
  • Maskning: Dubbel

Vapen och interventioner

Deltagargrupp / Arm
Intervention / Behandling
Experimentell: Arm I: nicotine inhaler cartridges

Participants receive 6-16 nicotine inhaler cartridges per day. Treatment continues for 12 weeks. After 12 weeks, participants are randomized a second time based on whether they continue to smoke or are smoke-free.

Participants randomized to arm I who continue to smoke are randomized to one of two treatment arms Arm IV or Arm V. Participants randomized to arm I who are smoke-free are randomized to one of two treatment arms Arm VIII or Arm IX.
Läkemedel: nikotin
Experimentell: Arm II: bupropion

Participants receive oral bupropion 1-2 times daily.

Treatment continues for 12 weeks. After 12 weeks, participants are randomized a second time based on whether they continue to smoke or are smoke-free. After 12 weeks, participants are randomized a second time based on whether they continue to smoke or are smoke-free.

Participants randomized to arm II who continue to smoke are randomized to one of two treatment arms Arm VI or Arm VII. Participants randomized to arm II who are smoke-free are randomized to one of two treatment arms Arm Arm X or Arm XI.
Läkemedel: bupropionhydroklorid
Experimentell: Arm III: nicotine inhaler cartridges

Participants receive 6-16 nicotine inhaler cartridges per day and oral bupropion 1-2 times daily. Treatment continues for 12 weeks. After 12 weeks, participants are randomized a second time based on whether they continue to smoke or are smoke-free.

Participants randomized to arm III who continue to smoke do not receive any further therapy. Participants randomized to arm III who are smoke-free are randomized to one of four treatment arms Arm XII, Arm XIII, Arm XIV or Arm XV.
Läkemedel: nikotin
Experimentell: Arm IV: bupropion

Participants receive oral bupropion 1-2 times daily for 12 weeks.

All participants are followed every month for 6 months.
Läkemedel: bupropionhydroklorid
Placebo-jämförare: Arm V: placebo

Participants receive oral placebo 1-2 times daily for 12 weeks.

All participants are followed every month for 6 months.
Övrig: placebo
Experimentell: Arm VI: nicotine inhaler cartridges

Participants receive 6-16 nicotine inhaler cartridges per day for 12 weeks.

All participants are followed every month for 6 months.
Läkemedel: nikotin
Placebo-jämförare: Arm VII: placebo inhaler

Participants receive 6-16 placebo inhaler cartridges per day for 12 weeks.

All participants are followed every month for 6 months.
Övrig: placebo
Experimentell: Arm VIII: nicotine inhaler cartridges

Participants receive 6-16 nicotine inhaler cartridges per day for 40 weeks.

All participants are followed every month for 6 months.
Läkemedel: nikotin
Placebo-jämförare: Arm IX: placebo inhaler cartridges

Participants receive 6-16 placebo inhaler cartridges per day for 40 weeks.

All participants are followed every month for 6 months.
Övrig: placebo
Experimentell: Arm X: bupropion

Participants receive oral bupropion 1-2 times daily for 40 weeks.

All participants are followed every month for 6 months.
Läkemedel: bupropionhydroklorid
Placebo-jämförare: Arm XI: placebo

Participants receive oral placebo 1-2 times daily for 40 weeks.

All participants are followed every month for 6 months.
Övrig: placebo
Experimentell: Arm XII: nicotine inhaler cartridges

Participants receive 6-16 nicotine inhaler cartridges per day and oral placebo 1-2 times daily for 40 weeks.

All participants are followed every month for 6 months.
Läkemedel: nikotin
Placebo-jämförare: Arm XIII: placebo inhaler cartridges

Participants receive 6-16 placebo inhaler cartridges per day and oral bupropion 1-2 times daily for 40 weeks.

All participants are followed every month for 6 months.
Övrig: placebo
Experimentell: Arm XIV: nicotine inhaler cartridges

Participants receive 6-16 nicotine inhaler cartridges per day and oral bupropion 1-2 times daily for 40 weeks.

All participants are followed every month for 6 months.
Läkemedel: nikotin
Placebo-jämförare: Arm XV: placebo inhaler cartridges

Participants receive 6-16 placebo inhaler cartridges per day and oral placebo 1-2 times daily for 40 weeks.

All participants are followed every month for 6 months.
Övrig: placebo

Vad mäter studien?

Primära resultatmått

Resultatmått
Tidsram
Prevention in relapse
Tidsram: Up to 6 months
Up to 6 months

Sekundära resultatmått

Resultatmått
Tidsram
Reduction in the rate of relapse
Tidsram: Up to 6 months
Up to 6 months

Samarbetspartners och utredare

Det är här du hittar personer och organisationer som är involverade i denna studie.

Sponsor

Alliance for Clinical Trials in Oncology

Samarbetspartners

National Cancer Institute (NCI)

Utredare

  • Studiestol: Richard D. Hurt, MD, Mayo Clinic

Studieavstämningsdatum

Dessa datum spårar framstegen för inlämningar av studieposter och sammanfattande resultat till ClinicalTrials.gov. Studieposter och rapporterade resultat granskas av National Library of Medicine (NLM) för att säkerställa att de uppfyller specifika kvalitetskontrollstandarder innan de publiceras på den offentliga webbplatsen.

Studera stora datum

Studiestart

1 februari 2002

Primärt slutförande (Faktisk)

1 juli 2006

Avslutad studie (Faktisk)

1 juli 2006

Studieregistreringsdatum

Först inskickad

9 april 2002

Först inskickad som uppfyllde QC-kriterierna

5 februari 2004

Första postat (Uppskatta)

6 februari 2004

Uppdateringar av studier

Senaste uppdatering publicerad (Uppskatta)

13 juli 2016

Senaste inskickade uppdateringen som uppfyllde QC-kriterierna

12 juli 2016

Senast verifierad

1 juli 2016

Mer information

Termer relaterade till denna studie

Nyckelord

Ytterligare relevanta MeSH-villkor

Andra studie-ID-nummer

  • NCCTG-N99C4
  • CDR0000069303 (Registeridentifierare: PDQ (Physician Data Query))
  • NCI-P02-0220

Denna information hämtades direkt från webbplatsen clinicaltrials.gov utan några ändringar. Om du har några önskemål om att ändra, ta bort eller uppdatera dina studieuppgifter, vänligen kontakta register@clinicaltrials.gov. Så snart en ändring har implementerats på clinicaltrials.gov, kommer denna att uppdateras automatiskt även på vår webbplats .

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