Ignite Creation Date:
2024-05-05 @ 11:25 AM
Last Modification Date:
2024-10-26 @ 9:07 AM
Study NCT ID:
NCT00033592
Status:
COMPLETED
Last Update Posted:
2016-07-13
First Post:
2002-04-09
Brief Title:
Comparison of Nicotine Inhaler andor Bupropion in Helping People to Stop Smoking and Prevent the Recurrence of Smoking
Sponsor:
Alliance for Clinical Trials in Oncology
Organization:
Alliance for Clinical Trials in Oncology
Study Overview
Official Title:
Phase III Trial Comparing Nicotine Inhaler Versus Bupropion Versus Nicotine Inhaler Plus Bupropion For Smoking Cessation Efficacy And Relapse Prevention
Status:
COMPLETED
Status Verified Date:
2016-07
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
RATIONALE Use of a nicotine inhaler andor 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
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
Detailed Description:
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
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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| CDR0000069303 | REGISTRY | None | None |
| NCI-P02-0220 | Registry Identifier | PDQ Physician Data Query | None |