Nicotine Dependence Clinical Trial
Official title:
Observational Study on Smoking Cessation and Cost Outcomes in the Duke Smoking Cessation Program
Verified date | September 2019 |
Source | Duke University |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Observational |
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.
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 |
Country | Name | City | State |
---|---|---|---|
United States | Duke Smoking Cessation Program | Durham | North Carolina |
Lead Sponsor | Collaborator |
---|---|
Duke University | National Institute on Drug Abuse (NIDA) |
United States,
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 |
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