Clinical trial NCT02845687: Study on Smoking Cessation and Cost Outcomes in the Duke Smoking Cessation Program
Official title: Observational Study on Smoking Cessation and Cost Outcomes in the Duke Smoking Cessation Program
Study type: OBSERVATIONAL
Overall status: TERMINATED
Conditions: Nicotine Dependence
Keywords: nicotine addiction
cigarette smoking
Lead sponsor: Duke University
Sponsor class: OTHER
Collaborators: name: National Institute on Drug Abuse (NIDA)
First posted: 2016-07-27
Enrollment: 209
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: This study will recruit participants through Quit at Duke, also called the Duke Smoking Cessation Program (DSCP). The DSCP is a growing multi-clinic tobacco use treatment program. The initial clinic site is at Duke Cancer Center, but it is positioned to expand over the next several years to include several other clinic sites within the Duke University Health System (DUHS). There are no exclusion criteria for this study.

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.

Eligibility criteria: Inclusion Criteria:

* Age 18 or older
* Being treated at the Duke Smoking Cessation Program
* Fluent in written and spoken English.

Exclusion Criteria: N/A

Primary outcomes:
measure: Biochemically confirmed continuous 30-day abstinence from smoking
timeFrame: 12 weeks post-Target Quit Day (TQD)
Secondary outcomes:
measure: Biochemically confirmed 7-day point prevalence abstinence from smoking
timeFrame: 2 weeks post-TQD
measure: Biochemically confirmed 7-day point prevalence abstinence from smoking
timeFrame: 12 weeks post-TQD
measure: Self-report 7-day point prevalence abstinence from smoking
timeFrame: 1 day post-TQD
measure: Self-report 7-day point prevalence abstinence from smoking
timeFrame: 1 week post-TQD
measure: Self-report 7-day point prevalence abstinence from smoking
timeFrame: 6 month post-TQD
measure: Self-report 7-day point prevalence abstinence from smoking
timeFrame: 12 month post-TQD
measure: Smoking reduction
timeFrame: 1 day post-TQD
measure: Smoking reduction
timeFrame: 1 week post-TQD
measure: Smoking reduction
timeFrame: 6 months post-TQD
measure: Smoking reduction
timeFrame: 12 months post-TQD
measure: Changes in stress
timeFrame: Baseline (pre-quit) to 2 and 12 weeks post-TQD
measure: Changes in anxiety
timeFrame: Baseline (pre-quit) to 2 and 12 weeks post-TQD
measure: Changes in depression
timeFrame: Baseline (pre-quit) to 2 and 12 weeks post-TQD
measure: Changes in relapse predictors
timeFrame: Baseline (pre-quit) to 1 day post-TQD, 1 week post-TQD, 6 months post-TQD, and 12 months post-TQD
measure: Overall cost of treatment in dollars per participant
timeFrame: 12 weeks post-TQD
measure: cost of medical visits in dollars per abstinent participant
timeFrame: 12 weeks post-TQD
measure: cost of medications per abstinent smoker
timeFrame: 12 weeks post-TQD
measure: cost of behavioral intervention per abstinent smoker
timeFrame: 12 weeks post-TQD
measure: cost of prescribed medications in dollars
timeFrame: 12 weeks post-TQD
Other outcomes:
measure: Feasibility: attendance records
timeFrame: up to 12 weeks post-TQD
measure: Feasibility: website usage
timeFrame: up to 12 weeks post-TQD
measure: Feasibility: course evaluation
timeFrame: up to 12 weeks post-TQD
measure: Feasibility: demographics
timeFrame: Baseline
measure: Feasibility: Medications Used
timeFrame: 12 weeks post-TQD
measure: Feasibility: Behavioral intervention used
timeFrame: 12 weeks post-TQD
measure: Feasibility: Attendance at DSCP appointments
timeFrame: 12 weeks post-TQD
measure: Feasibility: Referral routes to DSCP
timeFrame: Baseline
measure: Feasibility: Side effects
timeFrame: 1 day post-TQD
measure: Feasibility: Side effects
timeFrame: 1 week post-TQD
measure: Feasibility: Side effects
timeFrame: 6 months post-TQD
measure: Feasibility: Side effects
timeFrame: 12 months post-TQD
measure: Feasibility: medication adherence
timeFrame: 1 day post-TQD
measure: Feasibility: medication adherence
timeFrame: 1 week post-TQD
measure: Feasibility: medication adherence
timeFrame: 6 months post-TQD
measure: Feasibility: medication adherence
timeFrame: 12 months post-TQD
Locations:
city: Durham
country: United States
facility: Duke Smoking Cessation Program
state: North Carolina
Study officials:
affiliation: Duke University
name: James M Davis, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Taylor GM, Lindson N, Farley A, Leinberger-Jabari A, Sawyer K, Te Water Naude R, Theodoulou A, King N, Burke C, Aveyard P. Smoking cessation for improving mental health. Cochrane Database Syst Rev. 2021 Mar 9;3(3):CD013522. doi: 10.1002/14651858.CD013522.pub2.