Nicotine Dependence
Conditions
Keywords
nicotine addiction, cigarette smoking
Brief 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.
Detailed 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.
Interventions
None listed
Sponsors
National Institute on Drug Abuse (NIDA)
Duke University
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Age 18 or older * Being treated at the Duke Smoking Cessation Program * Fluent in written and spoken English.
Exclusion criteria
N/A
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Biochemically confirmed continuous 30-day abstinence from smoking | 12 weeks post-Target Quit Day (TQD) | 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 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Self-report 7-day point prevalence abstinence from smoking | 1 day post-TQD | 7-day point prevalence abstinence as measured by phone-based, single-item self-report |
| Smoking reduction | 1 day post-TQD | Smoking reduction as measured by cigarettes per day, as measured by phone-based self-report |
| Changes in stress | Baseline (pre-quit) to 2 and 12 weeks post-TQD | Change in self-reported measures of stress, as measured by Perceived Stress Scale |
| Changes in anxiety | Baseline (pre-quit) to 2 and 12 weeks post-TQD | Change in self-reported measures of anxiety, as measured by the GAD-7 |
| Changes in depression | Baseline (pre-quit) to 2 and 12 weeks post-TQD | Change in self-reported measures of depression, as measured by the PHQ-2 |
| Changes in relapse predictors | Baseline (pre-quit) to 1 day post-TQD, 1 week post-TQD, 6 months post-TQD, and 12 months post-TQD | Changes in self-reported measures on repeated non-standardized single-item question on stress, urges, and confidence assessed by phone |
| Overall cost of treatment in dollars per participant | 12 weeks post-TQD | — |
| cost of medical visits in dollars per abstinent participant | 12 weeks post-TQD | — |
| cost of medications per abstinent smoker | 12 weeks post-TQD | — |
| cost of behavioral intervention per abstinent smoker | 12 weeks post-TQD | — |
| Biochemically confirmed 7-day point prevalence abstinence from smoking | 2 weeks post-TQD | 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 |
| cost of prescribed medications in dollars | 12 weeks post-TQD | — |
Other
| Measure | Time frame | Description |
|---|---|---|
| Feasibility: website usage | up to 12 weeks post-TQD | 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 |
| Feasibility: course evaluation | up to 12 weeks post-TQD | Feasibility as measured by course evaluation |
| Feasibility: demographics | Baseline | Feasibility as measured by demographics of patients at DSCP |
| Feasibility: Medications Used | 12 weeks post-TQD | Feasibility as measured by medication use |
| Feasibility: Behavioral intervention used | 12 weeks post-TQD | Feasibility as measured by behavioral intervention assignment |
| Feasibility: Attendance at DSCP appointments | 12 weeks post-TQD | Feasibility as measured by attendance at DSCP appointments |
| Feasibility: Referral routes to DSCP | Baseline | Feasibility as measured by referral routes to DSCP |
| Feasibility: Side effects | 1 day post-TQD | Feasibility as measured by side effects, as measured by phone assessment |
| Feasibility: medication adherence | 1 day post-TQD | Feasibility as measured by medication adherence, as measured by phone assessment |
| Feasibility: attendance records | up to 12 weeks post-TQD | Feasibility as measured by attendance and completion of HIT and MIT assessed by attendance records taken by instructors at individual classes or sessions |
Countries
United States
Outcome results
None listed