Study on Sit to Quit Phone Intervention

NCT02840435 | Completed

• 2 other identifiers: Pro00073392P50DA027840
• Study Type: interventional
• Target: 23
• Locations: 1 country
• Sites: 1

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.

Conditions

Nicotine Dependence

Keywords

Nicotine addiction; Cigarette smoking

Outcome Measures

Primary Outcomes (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

  12 weeks post-Target Quit Day (TQD)

Secondary Outcomes (27)

• Biochemically confirmed 7-day point prevalence abstinence from smoking

  12 weeks post-TQD

• Biochemically confirmed 7-day point prevalence abstinence from smoking

  2 weeks post-TQD

• Self-reported 7-day point prevalence abstinence rates

  1 week post TQD

• Self-reported 7-day point prevalence abstinence rates

  12 weeks post TQD

• Self-reported 7-day point prevalence abstinence rates

  26 weeks post TQD

Study Arms (2)

North Carolina Quit Line: Quit for Life

ACTIVE COMPARATOR

Participants will be connected to the 'Quit for Life' program offered through the North Carolina Quit Line.

Behavioral: Quit for Life

Sit to Quit

EXPERIMENTAL

Participants will be connected to the 'Sit to Quit' program offered through the Duke Smoking Cessation Program.

Behavioral: Sit to Quit

Interventions

Sit to Quit BEHAVIORAL

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.

Also known as: Mindfulness Training for Smokers

Sit to Quit

Quit for Life BEHAVIORAL

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.

Also known as: North Carolina Quit Line

North Carolina Quit Line: Quit for Life

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• CO test under 7 ppm during initial screening
• or above on the Alcohol Use Disorders Identification Test (AUDIT-10)
• or above on Drug Abuse Screening Test (DAST-10)
• 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.

Sponsors & Collaborators

• Duke University: lead
• Consumer Wellness Solutions: collaborator
• National Institute on Drug Abuse (NIDA): collaborator

Study Sites (1)

Duke Center for Smoking Cessation

Durham, North Carolina, 27705, United States

Location

MeSH Terms

Conditions

Tobacco Use Disorder; Cigarette Smoking

Condition Hierarchy (Ancestors)

Substance-Related Disorders; Chemically-Induced Disorders; Mental Disorders; Tobacco Smoking; Smoking; Behavior; Tobacco Use

Study Officials

• James M Davis, MD

  Duke University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 5, 2016
• First Posted: July 21, 2016
• Study Start: September 1, 2016
• Primary Completion: February 1, 2018
• Study Completion: June 1, 2018
• Last Updated: September 13, 2019

Record last verified: 2019-09

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)