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Clinical Trial Details — Status: Terminated

Administrative data

NCT number NCT02845687
Other study ID # Pro00073920
Secondary ID P50DA027840
Status Terminated
Phase
First received
Last updated
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
Health authority
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

Study Design


Related Conditions & MeSH terms


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
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