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Nicotine DependenceNCT02840435

Study on Sit to Quit Phone Intervention

A study testing Sit to Quit and Quit for Life in people with Nicotine Dependence, run by Duke University at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

This study is designed to test the effectiveness of the smoking cessation intervention "Sit to Quit" through a randomized-control trial. This study will compare abstinence outcomes in the Sit to Quit study group to a control group using the North Carolina State Tobacco Quit Line. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Nicotine Dependence
What is being tested?
Sit to Quit and Quit for Life
Could I receive a placebo?
No, everyone receives an active treatment
How many people
23 participants
Where
1 siteUnited States
Study dates
Sep 2016to Jun 2018
Phase
Interventional
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

Who may be able to join

  • Patient being treated at Duke Smoking Cessation Program for tobacco use
  • Age 18 years or older
  • Actively smoking 5 or more cigarettes per day for at least one year
  • Fluency in spoken and written English
  • Willing to set a quit date within 2 weeks
  • Access to a smart phone or internet and telephone
  • Willingness to watch 3 videos on computer, receive 5 counseling calls, and attend investigational visits.

Who cannot join

  • CO test under 7 ppm during initial screening
  • 8 or above on the Alcohol Use Disorders Identification Test (AUDIT-10)
  • 6 or above on Drug Abuse Screening Test (DAST-10)
  • 3 or above on Patient Health Questionnaire (PHQ-2) Depression Scale
  • Daily use of a second form of tobacco or nicotine (e.g. e-cigarettes, cigars, chewing tobacco, snuff)
  • Current use of a smoking cessation medication (e.g. nicotine replacement, Varenicline, Bupropion)
  • Intolerable side effects related to, refusal to take, or medical contraindication with nicotine patch
  • Symptomatic cognitive or emotive disorder such as untreated schizophrenia, severe untreated depression, or severe untreated anxiety. This is determined by clinical assessment.

Trial locations and contacts

1 site in 1 country.

United States1 site

  • Duke Center for Smoking Cessation

    Durham, North Carolina, 27705

Other trials in United States

About this study

Official title: Pilot Study on Mindfulness Training for Smokers Via Web-based Video and Telephone Counseling

This study is designed to test the effectiveness of the smoking cessation intervention "Sit to Quit" through a randomized-control trial. This study will compare abstinence outcomes in the Sit to Quit study group to a control group using the North Carolina State Tobacco Quit Line.

Read the detailed description

This study is designed to test the effectiveness of the smoking cessation intervention "Sit to Quit" through a randomized-control trial. This study will compare abstinence outcomes in the Sit to Quit study group to a control group using the North Carolina State Tobacco Quit Line. This is an investigational study (n=60) designed to test Sit to Quit (STQ) versus Quit Line (QL) through a pilot randomized control trial. The proposed study is designed with double-blind procedures (participants and study staff) for randomization of 60 participants recruited through Duke Smoking Cessation Program into two groups: STQ and QL. STQ participants will receive access to the STQ Instructional Video, the STQ manual, and proactive Quit Coach calls supporting STQ. QL participants will be instructed to contact the NC Quit Line and will receive access to "web Coach" (Alere Well-being site), the Quit Line manual, and proactive Quit Coach calls supporting "Quit for Life." All statistical analysis will be performed under the directions of the statistician designated in key personnel. Outcomes of variables including: demographic variables, evaluation responses, and abstinence rates will be analyzed using general regression models using an ANOVA-based design. The study Principal Investigator Dr. James Davis will ultimately be responsible for data and safety monitoring. Subject data will be collected during visits and captured in the Electronic Medical Record. Data will be collected by phone, and this data will be stored in REDCap. Participants that experience events related to their clinical treatment will be recommended to follow-up with their provider.

Being tested
Sit to Quit, Quit for Life
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.

  • Sit to QuitBehavioural

    Also called Mindfulness Training for Smokers

    Sit to Quit(STQ) is a smoking cessation program adapted from Mindfulness Training for Smokers (MTS) with core content available on the STQ video. STQ contains many elements found in traditional interventions (e.g. instruction on planning and structuring a quit day, garnering support from others, assessment of prior relapse occasions, development of strategies to avoid triggers). In addition, STQ provides instruction in various mindfulness practices and in how to apply mindfulness skills to manage common causes of relapse. Exercises are provided, and it is recommended to learn the skill experientially. STQ requests that participants practice guided meditation each day using an audio recording and employ other mindfulness practices targeted to manage relapse challenges. Participants will also receive the STQ Participant Manual, which provides all the instruction found in the STQ Video, but provides additional discussion of topics for smokers who desire additional material.

  • Quit for LifeBehavioural

    Also called North Carolina Quit Line

    Quit for Life integrates telephone counseling, written materials, NRT, and an online program called "Web Coach." Web Coach is an interactive internet-based support system that provides health information on smoking cessation, assistance in the development of quit strategies, and an interactive blog to interact with other smokers. Web Coach is used by approximately 70% of AWI callers. Web Coach is not a complete program, but instead is designed to supplement AWI phone-based therapy. In addition, Quit for Life also provides the "Quit Guide," which is a smoking cessation manual with written instructions on the use of medications, planning a quit day, and cessation-related cognitive skills.

Study groups in NCT02840435
Study groupRoleWhat they receive
North Carolina Quit Line: Quit for LifeActive comparatorParticipants will be connected to the 'Quit for Life' program offered through the North Carolina Quit Line.
Receives: Behavioral: Quit for Life
Sit to QuitExperimentalParticipants will be connected to the 'Sit to Quit' program offered through the Duke Smoking Cessation Program.
Receives: Behavioral: Sit to Quit

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 (27)

  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: 12 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: 2 weeks post-TQD

  3. Self-reported 7-day point prevalence abstinence rates

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

    Measured: 1 week post TQD

  4. Self-reported 7-day point prevalence abstinence rates

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

    Measured: 12 weeks post TQD

  5. Self-reported 7-day point prevalence abstinence rates

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

    Measured: 26 weeks post TQD

  6. Self-reported 7-day point prevalence abstinence rates

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

    Measured: 6 weeks post TQD

  7. Self-reported 7-day point prevalence abstinence rates

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

    Measured: 2 weeks post TQD

  8. Smoking reduction

    Smoking reduction as measured by number of cpd measured by phone-based self-report

    Measured: 1 week post-TQD

  9. Smoking reduction

    Smoking reduction as measured by number of cpd measured by phone-based self-report

    Measured: 2 weeks post-TQD

  10. Smoking reduction

    Smoking reduction as measured by number of cpd measured by phone-based self-report

    Measured: 6 weeks post-TQD

  11. Smoking reduction

    Smoking reduction as measured by number of cpd measured by phone-based self-report

    Measured: 12 weeks post-TQD

  12. Smoking reduction

    Smoking reduction as measured by number of cpd measured by phone-based self-report

    Measured: 26 weeks post-TQD

  13. Changes in stress

    Change in self-reported measures of stress

    Measured: Baseline to 2-week and 12-week post TQD

  14. Changes in anxiety

    Change in self-reported measures of anxiety

    Measured: Baseline to 2-week and 12-week post TQD

  15. Changes in depression

    Change in self-reported measures of depression

    Measured: Baseline to 2-week and 12-week post TQD

  16. 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 to 1-week post-TQD, 2-week post-TQD, 6-week post-TQD, 12-week post-TQD, and 26-week post-TQD

  17. Feasibility: attendance records

    Feasibility as measured by attendance and completion of STQ and QL assessed by attendance records taken instructors during phone sessions.

    Measured: Up to 12 weeks post-TQD

  18. Feasibility: website usage

    Feasibility as measured by website usage by electronically recording login and using a site-based timer to record time accessing the site through each intervention

    Measured: Up to 12 weeks post-TQD

  19. Feasibility: course evaluation

    Feasibility as measured by course evaluation

    Measured: Up to 12 weeks post-TQD

  20. Feasibility: demographics

    Feasibility as measured by demographics of patients at DSCP

    Measured: 12-weeks post-TQD

  21. Feasibility: Behavioral intervention used

    Feasibility as measured by behavioral intervention assignment

    Measured: 12 weeks post-TQD

  22. Feasibility: Attendance at DSCP appointments

    Feasibility as measured by attendance at DSCP appointments

    Measured: 12 weeks post-TQD

  23. Feasibility: Referral routes to DSCP

    Feasibility as measured by referral routes to DSCP

    Measured: Baseline

  24. Feasibility: Side effects

    Feasibility as measured by side effects, as measured by phone assessment

    Measured: 1-week post-TQD, 2-week post-TQD, and 6-week post-TQD

  25. Feasibility: medication adherence

    Feasibility as measured by medication adherence, as measured by phone assessment

    Measured: 1-week post-TQD, 2-week post-TQD, 6-week post-TQD, and 26-week post-TQD

  26. Feasibility: mindfulness practices

    Feasibility as measured by non-standardized phone-based self-report of number of times mindfulness practices are used by experimental group

    Measured: 1-week post-TQD, 2-week post-TQD, 6-week post-TQD, and 26-week post-TQD

  27. Feasibility: meditation time

    Feasibility as measured by non-standardized phone-based self-report of time spent meditating by experimental group

    Measured: 1-week post-TQD, 2-week post-TQD, 6-week post-TQD, and 26-week 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 posted21 Jul 2016 (estimated)
  2. Study startSep 2016
  3. Primary completionFeb 2018
  4. Study completionJun 2018

Resources

More details

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

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
23 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02840435
Sponsor's protocol ID
Pro00073392
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

Questions about this trial

What is this clinical trial studying?

A study testing Sit to Quit and Quit for Life in people with 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 7 inclusion and 8 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: finished, 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 is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

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 NCT02840435.

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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