Comparison of Nicotine Inhaler and/or Bupropion in Helping People to Stop Smoking and Prevent the Recurrence of Smoking
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.
調査の概要
詳細な説明
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.
研究の種類
入学 (実際)
段階
- フェーズ 3
連絡先と場所
研究場所
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Arizona
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Scottsdale、Arizona、アメリカ、85259-5404
- CCOP - Scottsdale Oncology Program
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District of Columbia
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Washington、District of Columbia、アメリカ、20060
- MBCCOP-Howard University Cancer Center
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Illinois
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Peoria、Illinois、アメリカ、61602
- CCOP - Illinois Oncology Research Association
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Urbana、Illinois、アメリカ、61801
- CCOP - Carle Cancer Center
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Iowa
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Cedar Rapids、Iowa、アメリカ、52403-1206
- CCOP - Cedar Rapids Oncology Project
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Des Moines、Iowa、アメリカ、50309-1016
- CCOP - Iowa Oncology Research Association
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Sioux City、Iowa、アメリカ、51101-1733
- Siouxland Hematology-Oncology
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Kansas
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Wichita、Kansas、アメリカ、67214
- Cancer Center of Kansas - Wichita
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Wichita、Kansas、アメリカ、67214-3882
- CCOP - Wichita
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Louisiana
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New Orleans、Louisiana、アメリカ、70121
- CCOP - Ochsner
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Michigan
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Ann Arbor、Michigan、アメリカ、48106
- CCOP - Ann Arbor Regional
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Minnesota
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Duluth、Minnesota、アメリカ、55805
- CCOP - Duluth
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Rochester、Minnesota、アメリカ、55905
- Mayo Clinic Cancer Center
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Saint Cloud、Minnesota、アメリカ、56303
- CentraCare Clinic
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Saint Louis Park、Minnesota、アメリカ、55416
- CCOP - Metro-Minnesota
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Nebraska
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Omaha、Nebraska、アメリカ、68131
- CCOP - Missouri Valley Cancer Consortium
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North Dakota
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Bismarck、North Dakota、アメリカ、58501
- Medcenter One Health System
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Fargo、North Dakota、アメリカ、58122
- CCOP - Merit Care Hospital
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Grand Forks、North Dakota、アメリカ、58201
- Altru Health Systems
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Ohio
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Toledo、Ohio、アメリカ、43623-3456
- CCOP - Toledo Community Hospital Oncology Program
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Oklahoma
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Tulsa、Oklahoma、アメリカ、74136
- CCOP - Sooner State
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Pennsylvania
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Danville、Pennsylvania、アメリカ、17822-2001
- CCOP - Geisinger Clinic and Medical Center
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South Dakota
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Rapid City、South Dakota、アメリカ、57709
- Rapid City Regional Hospital
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Sioux Falls、South Dakota、アメリカ、57104
- CCOP - Sioux Community Cancer Consortium
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Saskatchewan
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Regina、Saskatchewan、カナダ、S4T 7T1
- Allan Blair Cancer Centre
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参加基準
適格基準
就学可能な年齢
健康ボランティアの受け入れ
受講資格のある性別
説明
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
研究計画
研究はどのように設計されていますか？
デザインの詳細
- 主な目的：防止
- 割り当て：ランダム化
- 介入モデル：クロスオーバー割り当て
- マスキング：ダブル
武器と介入
参加者グループ / アーム |
介入・治療 |
|---|---|
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実験的：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. |
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実験的：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. |
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実験的：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. |
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実験的：Arm IV: bupropion
Participants receive oral bupropion 1-2 times daily for 12 weeks. All participants are followed every month for 6 months. |
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プラセボコンパレーター：Arm V: placebo
Participants receive oral placebo 1-2 times daily for 12 weeks. All participants are followed every month for 6 months. |
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実験的：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. |
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プラセボコンパレーター：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. |
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実験的：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. |
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プラセボコンパレーター：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. |
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実験的：Arm X: bupropion
Participants receive oral bupropion 1-2 times daily for 40 weeks. All participants are followed every month for 6 months. |
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プラセボコンパレーター：Arm XI: placebo
Participants receive oral placebo 1-2 times daily for 40 weeks. All participants are followed every month for 6 months. |
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実験的：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. |
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プラセボコンパレーター：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. |
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実験的：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. |
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プラセボコンパレーター：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. |
この研究は何を測定していますか？
主要な結果の測定
結果測定 |
時間枠 |
|---|---|
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Prevention in relapse
時間枠：Up to 6 months
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Up to 6 months
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二次結果の測定
結果測定 |
時間枠 |
|---|---|
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Reduction in the rate of relapse
時間枠：Up to 6 months
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Up to 6 months
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協力者と研究者
捜査官
- スタディチェア：Richard D. Hurt, MD、Mayo Clinic
研究記録日
主要日程の研究
研究開始
一次修了 (実際)
研究の完了 (実際)
試験登録日
最初に提出
QC基準を満たした最初の提出物
最初の投稿 (見積もり)
学習記録の更新
投稿された最後の更新 (見積もり)
QC基準を満たした最後の更新が送信されました
最終確認日
詳しくは
本研究に関する用語
追加の関連 MeSH 用語
その他の研究ID番号
- NCCTG-N99C4
- CDR0000069303 (レジストリ識別子：PDQ (Physician Data Query))
- NCI-P02-0220
この情報は、Web サイト clinicaltrials.gov から変更なしで直接取得したものです。研究の詳細を変更、削除、または更新するリクエストがある場合は、register@clinicaltrials.gov。 までご連絡ください。 clinicaltrials.gov に変更が加えられるとすぐに、ウェブサイトでも自動的に更新されます。