Ignite Creation Date:
2024-05-05 @ 11:55 AM
Last Modification Date:
2024-10-26 @ 9:16 AM
Study NCT ID:
NCT00170079
Status:
COMPLETED
Last Update Posted:
2014-12-02
First Post:
2005-09-12
Brief Title:
Prolonged Smoking Cessation Using Prescription Step Care
Sponsor:
University of Tennessee
Organization:
University of Tennessee
Study Overview
Official Title:
Prolonged Smoking Cessation Using Prescription Step Care
Status:
COMPLETED
Status Verified Date:
2014-12
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:
Smoking is the number one preventable cause of morbidity and mortality in this nation Unfortunately more than 50 of those who quit following a smoking cessation intervention typically relapse within two weeks with approximately 80 relapsing within six months Therefore tobacco use can be conceptualized as a chronic condition As with many chronic medical problems tobacco use interventions may benefit from a step care approach to treatment
A total of 400 adult smokers will be enrolled in the study Participants will be randomly assigned to one of two treatment conditions consisting of 1 A State of the Art Smoking Cessation Intervention Recycling or 2 A State of the Art Smoking Cessation Intervention Step Care Long term smoking cessation will be assessed by self-report exhaled carbon monoxide levels and salivary cotinine The primary endpoint of the study will be smoking abstinence rates at two-year follow-up It is predicted that long-term cessation rates will be significantly higher in the step care condition than for those assigned to the recycling group
A total of 400 adult smokers will be enrolled in the study Participants will be randomly assigned to one of two treatment conditions consisting of 1 A State of the Art Smoking Cessation Intervention Recycling or 2 A State of the Art Smoking Cessation Intervention Step Care Long term smoking cessation will be assessed by self-report exhaled carbon monoxide levels and salivary cotinine The primary endpoint of the study will be smoking abstinence rates at two-year follow-up It is predicted that long-term cessation rates will be significantly higher in the step care condition than for those assigned to the recycling group
Detailed Description:
A common approach to increasing long-term adherence and control of chronic medical problems such as hypertension in both general and preventive medicine is the concept of step care Despite a high degree of interest in applying the step care model to smoking cessation Abrams et al 1996 Hughes 1994 little empirical work has been conducted utilizing this treatment approach The purpose of this study is to evaluate the long-term efficacy of a step care model for smoking cessation that is disseminable in primary care settings With that introduction we propose the following specific aims
Aim 1 To enroll approximately 400 adult cigarette smokers recruited mainly from primary care settings
Aim 2 To randomize these participants to 1 State of the Art Smoking Cessation Recycling or 2 State of the Art Smoking Cessation Step Care and
Aim 3 To evaluate the long-term 24 months post-randomization relative success of the interventions It is predicted that long-term cessation rates will be significantly higher in the step care condition
Aim 1 To enroll approximately 400 adult cigarette smokers recruited mainly from primary care settings
Aim 2 To randomize these participants to 1 State of the Art Smoking Cessation Recycling or 2 State of the Art Smoking Cessation Step Care and
Aim 3 To evaluate the long-term 24 months post-randomization relative success of the interventions It is predicted that long-term cessation rates will be significantly higher in the step care condition
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 |
|---|---|---|---|
| R01CA106667-01 | NIH | None | httpsreporternihgovquickSearchR01CA106667-01 |