Working…
COVID-19 is an emerging, rapidly evolving situation.
Get the latest public health information from CDC: https://www.coronavirus.gov.

Get the latest research information from NIH: https://www.nih.gov/coronavirus.
ClinicalTrials.gov
ClinicalTrials.gov Menu

Study on Sit to Quit Phone Intervention

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02840435
Recruitment Status : Completed
First Posted : July 21, 2016
Last Update Posted : September 13, 2019
Sponsor:
Collaborators:
Alere Wellbeing
National Institute on Drug Abuse (NIDA)
Information provided by (Responsible Party):
Duke University

Brief 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.

Condition or disease Intervention/treatment Phase
Nicotine Dependence Behavioral: Sit to Quit Behavioral: Quit for Life Not Applicable

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.

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 23 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Pilot Study on Mindfulness Training for Smokers Via Web-based Video and Telephone Counseling
Actual Study Start Date : September 2016
Actual Primary Completion Date : February 2018
Actual Study Completion Date : June 2018

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Active Comparator: North Carolina Quit Line: Quit for Life
Participants will be connected to the 'Quit for Life' program offered through the North Carolina Quit Line.
Behavioral: Quit for Life
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.
Other Name: North Carolina Quit Line

Experimental: Sit to Quit
Participants will be connected to the 'Sit to Quit' program offered through the Duke Smoking Cessation Program.
Behavioral: Sit to Quit
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.
Other Name: Mindfulness Training for Smokers




Primary Outcome Measures :
  1. Biochemically confirmed continuous 30-day abstinence from smoking [ Time Frame: 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 Outcome Measures :
  1. Biochemically confirmed 7-day point prevalence abstinence from smoking [ Time Frame: 12 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

  2. Biochemically confirmed 7-day point prevalence abstinence from smoking [ Time Frame: 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

  3. Self-reported 7-day point prevalence abstinence rates [ Time Frame: 1 week post TQD ]
    7-day point prevalence abstinence as measured by phone-based, single-item self-report

  4. Self-reported 7-day point prevalence abstinence rates [ Time Frame: 12 weeks post TQD ]
    7-day point prevalence abstinence as measured by phone-based, single-item self-report

  5. Self-reported 7-day point prevalence abstinence rates [ Time Frame: 26 weeks post TQD ]
    7-day point prevalence abstinence as measured by phone-based, single-item self-report

  6. Self-reported 7-day point prevalence abstinence rates [ Time Frame: 6 weeks post TQD ]
    7-day point prevalence abstinence as measured by phone-based, single-item self-report

  7. Self-reported 7-day point prevalence abstinence rates [ Time Frame: 2 weeks post TQD ]
    7-day point prevalence abstinence as measured by phone-based, single-item self-report

  8. Smoking reduction [ Time Frame: 1 week post-TQD ]
    Smoking reduction as measured by number of cpd measured by phone-based self-report

  9. Smoking reduction [ Time Frame: 2 weeks post-TQD ]
    Smoking reduction as measured by number of cpd measured by phone-based self-report

  10. Smoking reduction [ Time Frame: 6 weeks post-TQD ]
    Smoking reduction as measured by number of cpd measured by phone-based self-report

  11. Smoking reduction [ Time Frame: 12 weeks post-TQD ]
    Smoking reduction as measured by number of cpd measured by phone-based self-report

  12. Smoking reduction [ Time Frame: 26 weeks post-TQD ]
    Smoking reduction as measured by number of cpd measured by phone-based self-report

  13. Changes in stress [ Time Frame: Baseline to 2-week and 12-week post TQD ]
    Change in self-reported measures of stress

  14. Changes in anxiety [ Time Frame: Baseline to 2-week and 12-week post TQD ]
    Change in self-reported measures of anxiety

  15. Changes in depression [ Time Frame: Baseline to 2-week and 12-week post TQD ]
    Change in self-reported measures of depression

  16. Changes in relapse predictors [ Time Frame: Baseline to 1-week post-TQD, 2-week post-TQD, 6-week post-TQD, 12-week post-TQD, and 26-week post-TQD ]
    Changes in self-reported measures on repeated non-standardized single-item question on stress, urges, and confidence assessed by phone

  17. Feasibility: attendance records [ Time Frame: Up to 12 weeks post-TQD ]
    Feasibility as measured by attendance and completion of STQ and QL assessed by attendance records taken instructors during phone sessions.

  18. Feasibility: website usage [ Time Frame: Up to 12 weeks post-TQD ]
    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

  19. Feasibility: course evaluation [ Time Frame: Up to 12 weeks post-TQD ]
    Feasibility as measured by course evaluation

  20. Feasibility: demographics [ Time Frame: 12-weeks post-TQD ]
    Feasibility as measured by demographics of patients at DSCP

  21. Feasibility: Behavioral intervention used [ Time Frame: 12 weeks post-TQD ]
    Feasibility as measured by behavioral intervention assignment

  22. Feasibility: Attendance at DSCP appointments [ Time Frame: 12 weeks post-TQD ]
    Feasibility as measured by attendance at DSCP appointments

  23. Feasibility: Referral routes to DSCP [ Time Frame: Baseline ]
    Feasibility as measured by referral routes to DSCP

  24. Feasibility: Side effects [ Time Frame: 1-week post-TQD, 2-week post-TQD, and 6-week post-TQD ]
    Feasibility as measured by side effects, as measured by phone assessment

  25. Feasibility: medication adherence [ Time Frame: 1-week post-TQD, 2-week post-TQD, 6-week post-TQD, and 26-week post-TQD ]
    Feasibility as measured by medication adherence, as measured by phone assessment

  26. Feasibility: mindfulness practices [ Time Frame: 1-week post-TQD, 2-week post-TQD, 6-week post-TQD, and 26-week post-TQD ]
    Feasibility as measured by non-standardized phone-based self-report of number of times mindfulness practices are used by experimental group

  27. Feasibility: meditation time [ Time Frame: 1-week post-TQD, 2-week post-TQD, 6-week post-TQD, and 26-week post-TQD ]
    Feasibility as measured by non-standardized phone-based self-report of time spent meditating by experimental group



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • 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.

Exclusion Criteria:

  • 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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02840435


Locations
Layout table for location information
United States, North Carolina
Duke Center for Smoking Cessation
Durham, North Carolina, United States, 27705
Sponsors and Collaborators
Duke University
Alere Wellbeing
National Institute on Drug Abuse (NIDA)
Investigators
Layout table for investigator information
Principal Investigator: James M Davis, MD Duke University
Layout table for additonal information
Responsible Party: Duke University
ClinicalTrials.gov Identifier: NCT02840435    
Other Study ID Numbers: Pro00073392
P50DA027840 ( U.S. NIH Grant/Contract )
First Posted: July 21, 2016    Key Record Dates
Last Update Posted: September 13, 2019
Last Verified: September 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Keywords provided by Duke University:
Nicotine addiction
Cigarette smoking
Additional relevant MeSH terms:
Layout table for MeSH terms
Tobacco Use Disorder
Substance-Related Disorders
Chemically-Induced Disorders
Mental Disorders