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

NCT00033592 | Completed Phase 3

• 3 other identifiers: NCCTG-N99C4CDR0000069303NCI-P02-0220
• Study Type: interventional
• Target: 1,708
• Locations: 2 countries
• Sites: 25

Brief Summary

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.

Conditions

Lung Cancer

Keywords

non-small cell lung cancer; small cell lung cancer

Outcome Measures

Primary Outcomes (1)

• Prevention in relapse

  Up to 6 months

Secondary Outcomes (1)

• Reduction in the rate of relapse

  Up to 6 months

Study Arms (15)

Arm I: nicotine inhaler cartridges

EXPERIMENTAL

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.

Drug: nicotine

Arm II: bupropion

EXPERIMENTAL

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.

Drug: bupropion hydrochloride

Arm III: nicotine inhaler cartridges

EXPERIMENTAL

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.

Drug: nicotine

Arm IV: bupropion

EXPERIMENTAL

Participants receive oral bupropion 1-2 times daily for 12 weeks. All participants are followed every month for 6 months.

Drug: bupropion hydrochloride

Arm V: placebo

PLACEBO COMPARATOR

Participants receive oral placebo 1-2 times daily for 12 weeks. All participants are followed every month for 6 months.

Other: placebo

Arm VI: nicotine inhaler cartridges

EXPERIMENTAL

Participants receive 6-16 nicotine inhaler cartridges per day for 12 weeks. All participants are followed every month for 6 months.

Drug: nicotine

Arm VII: placebo inhaler

PLACEBO COMPARATOR

Participants receive 6-16 placebo inhaler cartridges per day for 12 weeks. All participants are followed every month for 6 months.

Other: placebo

Arm VIII: nicotine inhaler cartridges

EXPERIMENTAL

Participants receive 6-16 nicotine inhaler cartridges per day for 40 weeks. All participants are followed every month for 6 months.

Drug: nicotine

Arm IX: placebo inhaler cartridges

PLACEBO COMPARATOR

Participants receive 6-16 placebo inhaler cartridges per day for 40 weeks. All participants are followed every month for 6 months.

Other: placebo

Arm X: bupropion

EXPERIMENTAL

Participants receive oral bupropion 1-2 times daily for 40 weeks. All participants are followed every month for 6 months.

Drug: bupropion hydrochloride

Arm XI: placebo

PLACEBO COMPARATOR

Participants receive oral placebo 1-2 times daily for 40 weeks. All participants are followed every month for 6 months.

Other: placebo

Arm XII: nicotine inhaler cartridges

EXPERIMENTAL

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.

Drug: nicotine

Arm XIII: placebo inhaler cartridges

PLACEBO COMPARATOR

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.

Other: placebo

Arm XIV: nicotine inhaler cartridges

EXPERIMENTAL

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.

Drug: nicotine

Arm XV: placebo inhaler cartridges

PLACEBO COMPARATOR

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.

Other: placebo

Interventions

placebo OTHER

Arm IX: placebo inhaler cartridges; Arm V: placebo; Arm VII: placebo inhaler; Arm XI: placebo; Arm XIII: placebo inhaler cartridges; Arm XV: placebo inhaler cartridges

bupropion hydrochloride DRUG

Arm II: bupropion; Arm IV: bupropion; Arm X: bupropion

nicotine DRUG

Arm I: nicotine inhaler cartridges; Arm III: nicotine inhaler cartridges; Arm VI: nicotine inhaler cartridges; Arm VIII: nicotine inhaler cartridges; Arm XII: nicotine inhaler cartridges; Arm XIV: nicotine inhaler cartridges

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

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

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

• Alliance for Clinical Trials in Oncology: lead
• National Cancer Institute (NCI): collaborator

Study Sites (25)

CCOP - Scottsdale Oncology Program

Scottsdale, Arizona, 85259-5404, United States

Location

MBCCOP-Howard University Cancer Center

Washington D.C., District of Columbia, 20060, United States

Location

CCOP - Illinois Oncology Research Association

Peoria, Illinois, 61602, United States

Location

CCOP - Carle Cancer Center

Urbana, Illinois, 61801, United States

Location

CCOP - Cedar Rapids Oncology Project

Cedar Rapids, Iowa, 52403-1206, United States

Location

CCOP - Iowa Oncology Research Association

Des Moines, Iowa, 50309-1016, United States

Location

Siouxland Hematology-Oncology

Sioux City, Iowa, 51101-1733, United States

Location

CCOP - Wichita

Wichita, Kansas, 67214-3882, United States

Location

Cancer Center of Kansas - Wichita

Wichita, Kansas, 67214, United States

Location

CCOP - Ochsner

New Orleans, Louisiana, 70121, United States

Location

CCOP - Ann Arbor Regional

Ann Arbor, Michigan, 48106, United States

Location

CCOP - Duluth

Duluth, Minnesota, 55805, United States

Location

Mayo Clinic Cancer Center

Rochester, Minnesota, 55905, United States

Location

CentraCare Clinic

Saint Cloud, Minnesota, 56303, United States

Location

CCOP - Metro-Minnesota

Saint Louis Park, Minnesota, 55416, United States

Location

CCOP - Missouri Valley Cancer Consortium

Omaha, Nebraska, 68131, United States

Location

Medcenter One Health System

Bismarck, North Dakota, 58501, United States

Location

CCOP - Merit Care Hospital

Fargo, North Dakota, 58122, United States

Location

Altru Health Systems

Grand Forks, North Dakota, 58201, United States

Location

CCOP - Toledo Community Hospital Oncology Program

Toledo, Ohio, 43623-3456, United States

Location

CCOP - Sooner State

Tulsa, Oklahoma, 74136, United States

Location

CCOP - Geisinger Clinic and Medical Center

Danville, Pennsylvania, 17822-2001, United States

Location

Rapid City Regional Hospital

Rapid City, South Dakota, 57709, United States

Location

CCOP - Sioux Community Cancer Consortium

Sioux Falls, South Dakota, 57104, United States

Location

Allan Blair Cancer Centre

Regina, Saskatchewan, S4T 7T1, Canada

Location

Related Publications (1)

• Hajizadeh A, Howes S, Theodoulou A, Klemperer E, Hartmann-Boyce J, Livingstone-Banks J, Lindson N. Antidepressants for smoking cessation. Cochrane Database Syst Rev. 2023 May 24;5(5):CD000031. doi: 10.1002/14651858.CD000031.pub6.

  PMID: 37230961 DERIVED

MeSH Terms

Conditions

Lung Neoplasms; Carcinoma, Non-Small-Cell Lung; Small Cell Lung Carcinoma

Interventions

Bupropion; Nicotine

Condition Hierarchy (Ancestors)

Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Neoplasms; Lung Diseases; Respiratory Tract Diseases; Carcinoma, Bronchogenic; Bronchial Neoplasms

Intervention Hierarchy (Ancestors)

Propiophenones; Ketones; Organic Chemicals; Solanaceous Alkaloids; Alkaloids; Heterocyclic Compounds; Pyridines; Heterocyclic Compounds, 1-Ring

Study Officials

• Richard D. Hurt, MD

  Mayo Clinic

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: PREVENTION
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 9, 2002
• First Posted: February 6, 2004
• Study Start: February 1, 2002
• Primary Completion: July 1, 2006
• Study Completion: July 1, 2006
• Last Updated: July 13, 2016

Record last verified: 2016-07

Locations

US (24); CA (1)