Ignite Creation Date:
2024-05-05 @ 11:34 AM
Last Modification Date:
2024-10-26 @ 9:09 AM
Study NCT ID:
NCT00075972
Status:
COMPLETED
Last Update Posted:
2015-06-26
First Post:
2004-01-12
Brief Title:
Mood and Smoking A Comparison of Smoking Cessation Treatments
Sponsor:
US Department of Veterans Affairs
Organization:
VA Office of Research and Development
Study Overview
Official Title:
CSP 725 - Mood and Smoking A Comparison of Smoking Cessation Treatments
Status:
COMPLETED
Status Verified Date:
2015-06
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:
Objectives
The long term objectives of this research program are
1 To advance the mission of the VHA Boston Healthcare System to deliver comprehensive quality healthcare that meets the needs of patients in this case who have been unresponsive to standard smoking cessation treatment through research and clinical care
2 To expand upon our knowledge of the feasibility and effectiveness of commonly-used treatments for nicotine dependence
3 To further explore variables related to mood and coping that may contribute to or prevent successful reduction and cessation of smoking behavior among veterans
The short-term objectives of this project are
1 To evaluate the feasibility and effectiveness of two adjunctive treatments a mood-focused exposure-based treatment Mood Tolerance with Nicotine Replacement Therapy MTNRT and mood-focused affect-management treatment Mood Management with Nicotine Replacement Therapy MMNRT aimed at reduction and cessation of smoking behavior among veterans who were previously non-responders to smoking cessation treatment in the VA
2 To inform equivocal findings in the literature regarding the role of mood as trigger for smoking behavior
3 To explore selected mood coping and individual difference variable that may be predictive of successful abstinence from cigarettes among veterans
The long term objectives of this research program are
1 To advance the mission of the VHA Boston Healthcare System to deliver comprehensive quality healthcare that meets the needs of patients in this case who have been unresponsive to standard smoking cessation treatment through research and clinical care
2 To expand upon our knowledge of the feasibility and effectiveness of commonly-used treatments for nicotine dependence
3 To further explore variables related to mood and coping that may contribute to or prevent successful reduction and cessation of smoking behavior among veterans
The short-term objectives of this project are
1 To evaluate the feasibility and effectiveness of two adjunctive treatments a mood-focused exposure-based treatment Mood Tolerance with Nicotine Replacement Therapy MTNRT and mood-focused affect-management treatment Mood Management with Nicotine Replacement Therapy MMNRT aimed at reduction and cessation of smoking behavior among veterans who were previously non-responders to smoking cessation treatment in the VA
2 To inform equivocal findings in the literature regarding the role of mood as trigger for smoking behavior
3 To explore selected mood coping and individual difference variable that may be predictive of successful abstinence from cigarettes among veterans
Detailed Description:
Objectives
The short-term objectives of this project are
1 To evaluate the effectiveness of two adjunctive treatments mood-focused exposure-based treatment Mood Tolerance with Nicotine Replacement Therapy MT-NRT and mood-focused affect-management treatment Mood Management with NRT MM-NRT aimed at reduction and cessation of smoking behavior among veterans who were previously non-responders to smoking cessation treatment
2 To examine specific variables that may serve as mechanisms of action for successful treatment ie mood and coping variables
The long-term objectives of this research program are
1 To advance the mission of the VA to deliver comprehensive quality healthcare that meets the needs of patients who have been unresponsive to standard smoking cessation treatment through research and clinical care
2 To reduce the exorbitant healthcare costs of nicotine dependence ND to the VA and to improve veterans physical and psychological well-being healthcare utilization and mortality rates
3 To evaluate effectiveness of common treatments for ND
4 To explore mechanisms of action related to efficacy of treatment for ND among veterans ie changes in mood and coping
Research Design
This is a two-cell single-blind randomized treatment outcome study
Methodology
One hundred and twenty-eight smoking outpatients who have previously participated in standard group smoking cessation treatment treatment non-responders with NRT will be recruited through the VA Boston Outpatient Health Psychology Clinic Advertising flyers posted throughout the Boston VA Medical Center and Outpatient Clinic will be used to supplement this recruitment
Baseline Assessment
Interested and eligible patients will sign an informed consent form which will be thoroughly reviewed with each participant and co-signed by the investigators Baseline evaluation of the participants will take approximately 90 minutes This evaluation will include assessment of smoking-related variables moods and affect-regulation and coping strategies as well as carbon monoxide CO levels in expired breath
Treatment
Participants will be randomly assigned to one of the two treatments This will involve meeting with a pharmacist primary care physician psychiatrist or nurse practitioner to be screened for use of nicotine replacement therapy NRT transdermal patch and to initiate NRT use A member of the research team will continue to monitor the participants physical health during the course of the treatment In addition the participant will attend treatment groups once a week for 15 weeks These treatment groups will be conducted by a member of the research team or clinical students supervised by the PI Each of these groups will last 90 minutes
Follow-Up
The first follow-up appointment will take place in the week after completion of the treatment Additional follow-up assessments will take place at 3- 6- 9- and 12-months subsequent to the first follow-up appointment These assessments will be almost identical to the baseline assessment and will last approximately 90 minutes
Findings
Thirty-four participants have been enrolled in this study 12 of whom are currently actively involved in the protocol No data have been analyzed or presented yet
The short-term objectives of this project are
1 To evaluate the effectiveness of two adjunctive treatments mood-focused exposure-based treatment Mood Tolerance with Nicotine Replacement Therapy MT-NRT and mood-focused affect-management treatment Mood Management with NRT MM-NRT aimed at reduction and cessation of smoking behavior among veterans who were previously non-responders to smoking cessation treatment
2 To examine specific variables that may serve as mechanisms of action for successful treatment ie mood and coping variables
The long-term objectives of this research program are
1 To advance the mission of the VA to deliver comprehensive quality healthcare that meets the needs of patients who have been unresponsive to standard smoking cessation treatment through research and clinical care
2 To reduce the exorbitant healthcare costs of nicotine dependence ND to the VA and to improve veterans physical and psychological well-being healthcare utilization and mortality rates
3 To evaluate effectiveness of common treatments for ND
4 To explore mechanisms of action related to efficacy of treatment for ND among veterans ie changes in mood and coping
Research Design
This is a two-cell single-blind randomized treatment outcome study
Methodology
One hundred and twenty-eight smoking outpatients who have previously participated in standard group smoking cessation treatment treatment non-responders with NRT will be recruited through the VA Boston Outpatient Health Psychology Clinic Advertising flyers posted throughout the Boston VA Medical Center and Outpatient Clinic will be used to supplement this recruitment
Baseline Assessment
Interested and eligible patients will sign an informed consent form which will be thoroughly reviewed with each participant and co-signed by the investigators Baseline evaluation of the participants will take approximately 90 minutes This evaluation will include assessment of smoking-related variables moods and affect-regulation and coping strategies as well as carbon monoxide CO levels in expired breath
Treatment
Participants will be randomly assigned to one of the two treatments This will involve meeting with a pharmacist primary care physician psychiatrist or nurse practitioner to be screened for use of nicotine replacement therapy NRT transdermal patch and to initiate NRT use A member of the research team will continue to monitor the participants physical health during the course of the treatment In addition the participant will attend treatment groups once a week for 15 weeks These treatment groups will be conducted by a member of the research team or clinical students supervised by the PI Each of these groups will last 90 minutes
Follow-Up
The first follow-up appointment will take place in the week after completion of the treatment Additional follow-up assessments will take place at 3- 6- 9- and 12-months subsequent to the first follow-up appointment These assessments will be almost identical to the baseline assessment and will last approximately 90 minutes
Findings
Thirty-four participants have been enrolled in this study 12 of whom are currently actively involved in the protocol No data have been analyzed or presented yet
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