Ignite Creation Date:
2024-05-05 @ 11:33 AM
Last Modification Date:
2024-10-26 @ 9:10 AM
Study NCT ID:
NCT00079469
Status:
COMPLETED
Last Update Posted:
2012-03-08
First Post:
2004-03-08
Brief Title:
Bupropion and Counseling With or Without Contingency Management to Enhance Smoking Cessation in Treating Cancer Survivors Who Continue to Smoke
Sponsor:
National Institutes of Health Clinical Center CC
Organization:
National Institutes of Health Clinical Center CC
Study Overview
Official Title:
Contingency Management to Enhance Smoking Cessation for Cancer Survivors A Proof of Concept Trial
Status:
COMPLETED
Status Verified Date:
2012-03
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 Contingency management is a behavioral treatment approach that provides immediate rewards for positive change in behavior such as quitting smoking In this protocol contingency management will be in the form of a cash reward A smoking cessation stop-smoking program that combines contingency management with bupropion and counseling may be effective in helping cancer survivors stop smoking
PURPOSE Randomized clinical trial to compare the effectiveness of bupropion and counseling with or without contingency management in helping cancer survivors stop smoking
PURPOSE Randomized clinical trial to compare the effectiveness of bupropion and counseling with or without contingency management in helping cancer survivors stop smoking
Detailed Description:
OBJECTIVES
Primary
Compare the feasibility of a multi-component smoking cessation intervention comprising bupropion and counseling with or without contingency management cash reward for cancer survivors who continue to smoke
Compare 7-day point-prevalence abstinence rates in patients treated with these smoking cessation interventions
Secondary
Determine the characteristics of these patients that predict success at quitting smoking
OUTLINE This is a randomized multicenter study Patients are randomized to 1 of 2 smoking cessation intervention arms
Arm I Patients receive oral bupropion twice daily on weeks 1-12 and brief practical counseling ie problem-solving strategies stimulus control stress management and social support on weeks 1-6
Arm II Patients receive treatment as in arm I and contingency management ie monetary reinforcement for not smoking on weeks 1-6
In both arms treatment continues in the absence of unacceptable toxicity
Patients are followed at 12 and 24 weeks after the completion of the smoking cessation interventions
PROJECTED ACCRUAL A total of 100 patients 50 per intervention arm will be accrued for this study within 8 months
Primary
Compare the feasibility of a multi-component smoking cessation intervention comprising bupropion and counseling with or without contingency management cash reward for cancer survivors who continue to smoke
Compare 7-day point-prevalence abstinence rates in patients treated with these smoking cessation interventions
Secondary
Determine the characteristics of these patients that predict success at quitting smoking
OUTLINE This is a randomized multicenter study Patients are randomized to 1 of 2 smoking cessation intervention arms
Arm I Patients receive oral bupropion twice daily on weeks 1-12 and brief practical counseling ie problem-solving strategies stimulus control stress management and social support on weeks 1-6
Arm II Patients receive treatment as in arm I and contingency management ie monetary reinforcement for not smoking on weeks 1-6
In both arms treatment continues in the absence of unacceptable toxicity
Patients are followed at 12 and 24 weeks after the completion of the smoking cessation interventions
PROJECTED ACCRUAL A total of 100 patients 50 per intervention arm will be accrued for this study within 8 months
Study Oversight
Has Oversight DMC:
Is a FDA Regulated Drug?:
Is a FDA Regulated Device?:
Is an Unapproved Device?:
Is a PPSD?:
Is a US Export?:
Is an FDA AA801 Violation?:
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| 03-C-N308 | None | None | None |
| CDR0000356037 | None | None | None |