Alert icon

To align with industry best practices for security and data integrity, Project Data Sphere is requiring users to upgrade their browsers to one that supports encryption protocol TLS 1.2 by December 15, 2017. On that date, Project Data Sphere will disable support of browsers that permit SSL 3.0/TLS 1.0. To prevent any disruption to your access to Project Data Sphere, you must take action.
This browser was not recognized and may not be compatible with TLS 1.2 or higher. Please check with the browser's developer to confirm.
To view information about this, please visit the FAQ. If you have any further questions, please contact us.

Lung (Non-Small Cell), and Lung (Small Cell)

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

Unique Dataset IDNCT00033592
SponsorAlliance for Clinical Trials in OncologyData ProviderThe Alliance for Clinical Trials in OncologyTotal Study Enrolled Patients1708Comparator (Control) Arm Enrolled Patients470Experimental (Active) Arm Enrolled Patients1238RandomizationYes
Study PhaseClinical Study Phase IIIBlinding MethodDouble-BlindedType(s) of dataBoth comparator and experimental arm dataIntervention TypeOtherDataset TypeADS

Clinical Trial Title

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

Trial Summary and Conditions

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.

Data Summary

Control and experimental arm data files include data on safety, efficacy, demographics etc. See the data dictionary provided for more details.

Study Objectives

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.

Outcome Measures

Prevention in relapse [ Time Frame: Up to 6 months ]

Available Downloads:

To gain access to the data and analytic tools click here.

PROTOCOL: n99c4_protocol.doc

CRF: n99c4_forms.pdf

DATA DICTIONARY: n99c4_ddt.docx

OTHER: chklist2.sas7bdat

OTHER: chklist.sas7bdat

OTHER: fagerstm.sas7bdat

OTHER: end_at.sas7bdat

OTHER: relapse.sas7bdat

OTHER: casecrse.sas7bdat

OTHER: wt_scale.sas7bdat

OTHER: smokehx.sas7bdat

OTHER: visit.sas7bdat