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Nicotine DependenceNCT02845687

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

An observational study of Nicotine Dependence, run by Duke University at 1 site in United States.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record
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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. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Nicotine Dependence
How many people
209 participants
Where
1 siteUnited States
Study dates
16 Aug 2016to 29 May 2018
Phase
Observational
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

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.

Who may be able to join

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

Who cannot join

None listed.

Trial locations and contacts

1 site in 1 country.

United States1 site

  • Duke Smoking Cessation Program

    Durham, North Carolina, 27705

Other trials in United States

About this study

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

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.

Read the 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.

Keywords
nicotine addiction, cigarette smoking
Medical subject headings
Tobacco Use Disorder, Cigarette Smoking

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Study groups in NCT02845687
Study groupRoleWhat they receive
ParticipantsAll participants are patients within the Quit at Duke Smoking Cessation Program. This is an observational study with no interventions.

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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

    Measured: 12 weeks post-Target Quit Day (TQD)

Secondary outcomes (19)

  1. 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

    Measured: 2 weeks post-TQD

  2. 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

    Measured: 12 weeks post-TQD

  3. Self-report 7-day point prevalence abstinence from smoking

    7-day point prevalence abstinence as measured by phone-based, single-item self-report

    Measured: 1 day post-TQD

  4. Self-report 7-day point prevalence abstinence from smoking

    7-day point prevalence abstinence as measured by phone-based, single-item self-report

    Measured: 1 week post-TQD

  5. Self-report 7-day point prevalence abstinence from smoking

    7-day point prevalence abstinence as measured by phone-based, single-item self-report

    Measured: 6 month post-TQD

  6. Self-report 7-day point prevalence abstinence from smoking

    7-day point prevalence abstinence as measured by phone-based, single-item self-report

    Measured: 12 month post-TQD

  7. Smoking reduction

    Smoking reduction as measured by cigarettes per day, as measured by phone-based self-report

    Measured: 1 day post-TQD

  8. Smoking reduction

    Smoking reduction as measured by cigarettes per day, as measured by phone-based self-report

    Measured: 1 week post-TQD

  9. Smoking reduction

    Smoking reduction as measured by cigarettes per day, as measured by phone-based self-report

    Measured: 6 months post-TQD

  10. Smoking reduction

    Smoking reduction as measured by cigarettes per day, as measured by phone-based self-report

    Measured: 12 months post-TQD

  11. Changes in stress

    Change in self-reported measures of stress, as measured by Perceived Stress Scale

    Measured: Baseline (pre-quit) to 2 and 12 weeks post-TQD

  12. Changes in anxiety

    Change in self-reported measures of anxiety, as measured by the GAD-7

    Measured: Baseline (pre-quit) to 2 and 12 weeks post-TQD

  13. Changes in depression

    Change in self-reported measures of depression, as measured by the PHQ-2

    Measured: Baseline (pre-quit) to 2 and 12 weeks post-TQD

  14. Changes in relapse predictors

    Changes in self-reported measures on repeated non-standardized single-item question on stress, urges, and confidence assessed by phone

    Measured: Baseline (pre-quit) to 1 day post-TQD, 1 week post-TQD, 6 months post-TQD, and 12 months post-TQD

  15. Overall cost of treatment in dollars per participant

    Measured: 12 weeks post-TQD

  16. cost of medical visits in dollars per abstinent participant

    Measured: 12 weeks post-TQD

  17. cost of medications per abstinent smoker

    Measured: 12 weeks post-TQD

  18. cost of behavioral intervention per abstinent smoker

    Measured: 12 weeks post-TQD

  19. cost of prescribed medications in dollars

    Measured: 12 weeks post-TQD

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted27 Jul 2016 (estimated)
  2. Study start16 Aug 2016
  3. Primary completion29 May 2018
  4. Study completion29 May 2018

Why it stopped: Per NIH request

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Cohort
Time perspective
Prospective
Enrolment
209 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02845687
Sponsor's protocol ID
Pro00073920
Other IDs
P50DA027840
Status last verified
Sep 2019
First submitted
5 Jul 2016
Last updated
13 Sep 2019
Results posted
No
Data monitoring committee
No
Individual data sharing
No

Publications

  • 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.

    PubMed 33687070

Questions about this trial

What is this clinical trial studying?

An observational study of Nicotine Dependence, run by Duke University at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 0 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: stopped early, as of the sponsor's last update on 13 Sep 2019. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study was stopped early (reason given: Per NIH request). Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Biochemically confirmed continuous 30-day abstinence from smoking (time frame: 12 weeks post-Target Quit Day (TQD)). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02845687, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Sep 2019.

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