Study on Smoking Cessation and Cost Outcomes in the Duke Smoking Cessation Program

Nicotine Dependence Clinical Trial

Official title:

Observational Study on Smoking Cessation and Cost Outcomes in the Duke Smoking Cessation Program

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT02845687
• Other study ID #: Pro00073920
• Secondary ID: P50DA027840
• Status: Terminated
• Start date: August 16, 2016
• Est. completion date: May 29, 2018

Study information

• Verified date: September 2019
• Source: Duke University
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

The purpose of this study is to conduct an observational assessment of natural outcomes within the Duke Smoking Cessation Program (DSCP), "Quit at Duke." This assessment will include information regarding abstinence rates, changes in patient emotional state following treatment, and costs of operations. Primarily, this study will assess the financial sustainability and the cost-effectiveness of the program.

Description:

The purpose of this study is to conduct an observational assessment of natural outcomes within the DSCP, "Quit at Duke." This is an observational study (n=3000) on patients being treated at the DSCP. No interventions are conducted, and data analyzed is collected in the course of clinical care at clinic visits to the Duke Smoking Cessation Program (DSCP). Phone calls are also conducted to determine response to medications and abstinence status up to 12 months following a quit attempt. Outcomes of variables including: demographic variables, evaluation responses, feasibility data, and abstinence rates will be analyzed using general regression models using an ANOVA-based design. Because no intervention is being conducted, there are no safety concerns related to the study.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 209
• Est. completion date: May 29, 2018
• Est. primary completion date: May 29, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Age 18 or older

• Being treated at the Duke Smoking Cessation Program

• Fluent in written and spoken English.

Exclusion Criteria: N/A

Related Conditions & MeSH terms

• Nicotine Dependence
• Tobacco Use Disorder

Locations

Country	Name	City	State
United States	Duke Smoking Cessation Program	Durham	North Carolina

Sponsors (2)

Lead Sponsor	Collaborator
Duke University	National Institute on Drug Abuse (NIDA)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Feasibility: attendance records	Feasibility as measured by attendance and completion of HIT and MIT assessed by attendance records taken by instructors at individual classes or sessions	up to 12 weeks post-TQD
Other	Feasibility: website usage	Feasibility as measured by website usage, as measured by electronically recorded login and site-based timer will record time accessing the site through each intervention	up to 12 weeks post-TQD
Other	Feasibility: course evaluation	Feasibility as measured by course evaluation	up to 12 weeks post-TQD
Other	Feasibility: demographics	Feasibility as measured by demographics of patients at DSCP	Baseline
Other	Feasibility: Medications Used	Feasibility as measured by medication use	12 weeks post-TQD
Other	Feasibility: Behavioral intervention used	Feasibility as measured by behavioral intervention assignment	12 weeks post-TQD
Other	Feasibility: Attendance at DSCP appointments	Feasibility as measured by attendance at DSCP appointments	12 weeks post-TQD
Other	Feasibility: Referral routes to DSCP	Feasibility as measured by referral routes to DSCP	Baseline
Other	Feasibility: Side effects	Feasibility as measured by side effects, as measured by phone assessment	1 day post-TQD
Other	Feasibility: Side effects	Feasibility as measured by side effects, as measured by phone assessment	1 week post-TQD
Other	Feasibility: Side effects	Feasibility as measured by side effects, as measured by phone assessment	6 months post-TQD
Other	Feasibility: Side effects	Feasibility as measured by side effects, as measured by phone assessment	12 months post-TQD
Other	Feasibility: medication adherence	Feasibility as measured by medication adherence, as measured by phone assessment	1 day post-TQD
Other	Feasibility: medication adherence	Feasibility as measured by medication adherence, as measured by phone assessment	1 week post-TQD
Other	Feasibility: medication adherence	Feasibility as measured by medication adherence, as measured by phone assessment	6 months post-TQD
Other	Feasibility: medication adherence	Feasibility as measured by medication adherence, as measured by phone assessment	12 months post-TQD
Primary	Biochemically confirmed continuous 30-day abstinence from smoking	Biochemically confirmed 30-day continuous abstinence. Abstinence is determined by a participant both reporting not smoking in the past 30 days AND a result of < 7 ppm in carbon monoxide breath testing. If the participant does not meet both criteria, they are not considered abstinent	12 weeks post-Target Quit Day (TQD)
Secondary	Biochemically confirmed 7-day point prevalence abstinence from smoking	Biochemically confirmed 7-day continuous abstinence. Abstinence is determined by a participant both reporting not smoking in the past 7 days AND a result of < 7 ppm in carbon monoxide breath testing. If the participant does not meet both criteria, they are not considered abstinent	2 weeks post-TQD
Secondary	Biochemically confirmed 7-day point prevalence abstinence from smoking	Biochemically confirmed 7-day continuous abstinence. Abstinence is determined by a participant both reporting not smoking in the past 7 days AND a result of < 7 ppm in carbon monoxide breath testing. If the participant does not meet both criteria, they are not considered abstinent	12 weeks post-TQD
Secondary	Self-report 7-day point prevalence abstinence from smoking	7-day point prevalence abstinence as measured by phone-based, single-item self-report	1 day post-TQD
Secondary	Self-report 7-day point prevalence abstinence from smoking	7-day point prevalence abstinence as measured by phone-based, single-item self-report	1 week post-TQD
Secondary	Self-report 7-day point prevalence abstinence from smoking	7-day point prevalence abstinence as measured by phone-based, single-item self-report	6 month post-TQD
Secondary	Self-report 7-day point prevalence abstinence from smoking	7-day point prevalence abstinence as measured by phone-based, single-item self-report	12 month post-TQD
Secondary	Smoking reduction	Smoking reduction as measured by cigarettes per day, as measured by phone-based self-report	1 day post-TQD
Secondary	Smoking reduction	Smoking reduction as measured by cigarettes per day, as measured by phone-based self-report	1 week post-TQD
Secondary	Smoking reduction	Smoking reduction as measured by cigarettes per day, as measured by phone-based self-report	6 months post-TQD
Secondary	Smoking reduction	Smoking reduction as measured by cigarettes per day, as measured by phone-based self-report	12 months post-TQD
Secondary	Changes in stress	Change in self-reported measures of stress, as measured by Perceived Stress Scale	Baseline (pre-quit) to 2 and 12 weeks post-TQD
Secondary	Changes in anxiety	Change in self-reported measures of anxiety, as measured by the GAD-7	Baseline (pre-quit) to 2 and 12 weeks post-TQD
Secondary	Changes in depression	Change in self-reported measures of depression, as measured by the PHQ-2	Baseline (pre-quit) to 2 and 12 weeks post-TQD
Secondary	Changes in relapse predictors	Changes in self-reported measures on repeated non-standardized single-item question on stress, urges, and confidence assessed by phone	Baseline (pre-quit) to 1 day post-TQD, 1 week post-TQD, 6 months post-TQD, and 12 months post-TQD
Secondary	Overall cost of treatment in dollars per participant		12 weeks post-TQD
Secondary	cost of medical visits in dollars per abstinent participant		12 weeks post-TQD
Secondary	cost of medications per abstinent smoker		12 weeks post-TQD
Secondary	cost of behavioral intervention per abstinent smoker		12 weeks post-TQD
Secondary	cost of prescribed medications in dollars		12 weeks post-TQD