Ignite Creation Date:
2024-05-05 @ 11:54 AM
Last Modification Date:
2024-10-26 @ 9:16 AM
Study NCT ID:
NCT00178685
Status:
COMPLETED
Last Update Posted:
2013-02-15
First Post:
2005-09-13
Brief Title:
Smokers Health Project Self-Determination and Maintaining Tobacco Abstinence
Sponsor:
University of Rochester
Organization:
University of Rochester
Study Overview
Official Title:
Self-determination and Maintaining Tobacco Abstinence
Status:
COMPLETED
Status Verified Date:
2009-07
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:
SHP
Brief Summary:
These two studies will examine the role of autonomous motivation in maintained adherence The first study will determine whether smokers are still abstinent from tobacco 32 months after starting in a previous project Smokers Health Study The purpose of the second study is to determine which of three treatments for tobacco dependence provides the greatest amount of protection from relapsing to smoking after quitting Specifically the investigators will determine if extending the length of treatment time focusing on relapse prevention and arranging for support from important others prevents relapse compared to community care Also the investigators will determine if providing extended treatment time and support from important others plus providing medications to those that dont want to quit prevents long term relapse compared to just extending the length of treatment time and support from others Additionally a sub set of the population will be randomized to using hand held palm devices to recover real-time data assessment during the last 10 months of the project
Detailed Description:
These two studies will extend our examination of self-determination theory SDT based counseling interventions to the issue of maintained abstinence from tobacco use Two projects are proposed both of which build on the results of our current trial The first is a 32-month follow-up of the smoking status of patients in the preceding trial called the Smokers Health Study self-determination smoking diet and health That SDT intervention 4 counselor visits over 6 months increased cessation at 6 months relative to community care and was also effective in increasing 12 month prolonged abstinence and the results have been reported in two manuscripts Williams McGregor Sharp Levesque Kouides Ryan and Deci In press Williams McGregor Sharp Levesque Kouides Ryan and Deci 2005 The part of this first project that will be conducted as part of this grant will be to complete 32 month follow-up of smokers in the Smokers Health Study The second project is a 3-cell clinical trial called the Smokers Health Project that will examine two extensions of the current intervention both of which place greater emphasis on use of and adherence to cessation medications The two arms will be compared to community care Both arms involve two visits with a physician to discuss medications and side effects In both interventions counselors will address medication adherence The two arms differ in that patients not ready to quit in one arm will receive a smoking reduction approach with medications in which they first try to reduce their smoking to half and then attempt cessation In addition to place greater emphasis on medications and to examine medication adherence as a mediator of maintained cessation
There will be two major changes in the intervention intended to facilitate long-term maintenance First the intervention will extend over 12 months whereas the current one lasts only 6 months with meetings during the additional 6 months focusing on maintenance and relapse prevention Second at least one family member or best friend of each patient will be encouraged to meet with a counselor to learn how to be more autonomy supportive with the patient around issues related to tobacco Cessation and maintained abstinence will be examined with logistic regression The SDT process model of maintained cessation will be tested using structural equation modeling and cost-effectiveness analyses will be done for the interventions
There will be two major changes in the intervention intended to facilitate long-term maintenance First the intervention will extend over 12 months whereas the current one lasts only 6 months with meetings during the additional 6 months focusing on maintenance and relapse prevention Second at least one family member or best friend of each patient will be encouraged to meet with a counselor to learn how to be more autonomy supportive with the patient around issues related to tobacco Cessation and maintained abstinence will be examined with logistic regression The SDT process model of maintained cessation will be tested using structural equation modeling and cost-effectiveness analyses will be done for the interventions
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 |
|---|---|---|---|
| 1R21CA119112-01A2 | NIH | None | httpsreporternihgovquickSearch1R21CA119112-01A2 |
| R01 CA10666 | None | None | None |