Ignite Creation Date:
2024-05-05 @ 4:45 PM
Last Modification Date:
2024-10-26 @ 9:23 AM
Study NCT ID:
NCT00301145
Status:
COMPLETED
Last Update Posted:
2013-12-19
First Post:
2006-03-08
Brief Title:
Varenicline Tartrate With Telephone-Based Counseling andor Internet-Based Counseling in Helping Adults Stop Smoking
Sponsor:
SRI International
Organization:
National Cancer Institute NCI
Study Overview
Official Title:
Treatment of Nicotine Dependence in a Health Care Setting
Status:
COMPLETED
Status Verified Date:
2007-09
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 Varenicline tartrate may help people quit smoking by decreasing the symptoms of nicotine withdrawal It is not yet known whether varenicline tartrate is more effective in helping people stop smoking when given together with a telephone-based counseling program and Internet-based counseling program or both programs
PURPOSE This randomized clinical trial is studying how well giving varenicline tartrate together with a telephone-based counseling program andor an Internet-based counseling program works in helping adults stop smoking
PURPOSE This randomized clinical trial is studying how well giving varenicline tartrate together with a telephone-based counseling program andor an Internet-based counseling program works in helping adults stop smoking
Detailed Description:
OBJECTIVES
Determine the effectiveness of varenicline with telephone counseling vs Internet-based counseling vs telephone counseling and Internet-based smoking cessation interventions in adult smokers
Determine individual or group differences in patients undergoing these interventions
Determine heterogeneity in responsiveness in regard to the Classification and Regression Tree Analysis in patients undergoing these interventions
Determine the effectiveness of these interventions in regard to recruitment implementation barriers to treatment exposure to intervention satisfaction with treatment treatment contamination and program maintenance
Determine the cost-effectiveness of these interventions
OUTLINE This is a randomized open-label study Patients are randomized to 1 of 3 intervention arms
Arm I Patients undergo a proactive telephone-based PTB smoking cessation program
Arm II Patients undergo a web-based WB smoking cessation program
Arm III Patients undergo an integrated PTBWB smoking cessation program Beginning 1 week before the target quit date all patients receive oral varenicline once daily for 3 days and then twice daily for up to 12 weeks They also receive a mailed packet containing a welcome letter description of the intervention services offered a privacy notice a Free Clear Quit Kit comprehensive educationself-help materials including health smoking substitutions a phone call to orient the patient to the intervention to which they are randomized and access to a toll-free support line All patients undergo a pre-treatment assessment pre-quit and 3 post-quit assessments at 21 days 12 weeks and 6 months after their original scheduled quit date to determine medication adherence treatment utilization point-prevalent smoking outcomes and continuous nonsmoking
PROJECTED ACCRUAL A total of 1200 patients will be accrued for this study
Determine the effectiveness of varenicline with telephone counseling vs Internet-based counseling vs telephone counseling and Internet-based smoking cessation interventions in adult smokers
Determine individual or group differences in patients undergoing these interventions
Determine heterogeneity in responsiveness in regard to the Classification and Regression Tree Analysis in patients undergoing these interventions
Determine the effectiveness of these interventions in regard to recruitment implementation barriers to treatment exposure to intervention satisfaction with treatment treatment contamination and program maintenance
Determine the cost-effectiveness of these interventions
OUTLINE This is a randomized open-label study Patients are randomized to 1 of 3 intervention arms
Arm I Patients undergo a proactive telephone-based PTB smoking cessation program
Arm II Patients undergo a web-based WB smoking cessation program
Arm III Patients undergo an integrated PTBWB smoking cessation program Beginning 1 week before the target quit date all patients receive oral varenicline once daily for 3 days and then twice daily for up to 12 weeks They also receive a mailed packet containing a welcome letter description of the intervention services offered a privacy notice a Free Clear Quit Kit comprehensive educationself-help materials including health smoking substitutions a phone call to orient the patient to the intervention to which they are randomized and access to a toll-free support line All patients undergo a pre-treatment assessment pre-quit and 3 post-quit assessments at 21 days 12 weeks and 6 months after their original scheduled quit date to determine medication adherence treatment utilization point-prevalent smoking outcomes and continuous nonsmoking
PROJECTED ACCRUAL A total of 1200 patients will be accrued for this study
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 |
|---|---|---|---|
| SRI-751 | None | None | None |