Study on Sit to Quit Phone Intervention

• Register: ClinicalTrials.gov
• Last refreshed on: 12 December 2020
• Main ID: NCT02840435
• Date of registration: 05/07/2016
• Prospective Registration: Yes
• Primary sponsor: Duke University
• Public title: Study on Sit to Quit Phone Intervention
• Scientific title: Pilot Study on Mindfulness Training for Smokers Via Web-based Video and Telephone Counseling
• Date of first enrolment: September 2016
• Target sample size: 23
• Recruitment status: Completed
• URL: https://clinicaltrials.gov/show/NCT02840435
• Study type: Interventional
• Study design: Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Treatment. Masking: None (Open Label).
• Phase: N/A

Countries of recruitment

United States

Contacts

• Name: James M Davis, MD
• Affiliation: Duke University

Key inclusion & exclusion 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.



Age minimum: 18 Years
Age maximum: N/A
Gender: All

Health Condition(s) or Problem(s) studied

Nicotine Dependence

Intervention(s)

Behavioral: Quit for Life

Behavioral: Sit to Quit

Primary Outcome(s)

Biochemically confirmed continuous 30-day abstinence from smoking [Time Frame: 12 weeks post-Target Quit Day (TQD)]

Secondary Outcome(s)

Feasibility: medication adherence [Time Frame: 1-week post-TQD, 2-week post-TQD, 6-week post-TQD, and 26-week post-TQD]

Feasibility: mindfulness practices [Time Frame: 1-week post-TQD, 2-week post-TQD, 6-week post-TQD, and 26-week post-TQD]

Feasibility: Referral routes to DSCP [Time Frame: Baseline]

Smoking reduction [Time Frame: 2 weeks post-TQD]

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]

Feasibility: Attendance at DSCP appointments [Time Frame: 12 weeks post-TQD]

Smoking reduction [Time Frame: 1 week post-TQD]

Changes in stress [Time Frame: Baseline to 2-week and 12-week post TQD]

Feasibility: demographics [Time Frame: 12-weeks post-TQD]

Feasibility: attendance records [Time Frame: Up to 12 weeks post-TQD]

Self-reported 7-day point prevalence abstinence rates [Time Frame: 6 weeks post TQD]

Self-reported 7-day point prevalence abstinence rates [Time Frame: 2 weeks post TQD]

Biochemically confirmed 7-day point prevalence abstinence from smoking [Time Frame: 12 weeks post-TQD]

Feasibility: meditation time [Time Frame: 1-week post-TQD, 2-week post-TQD, 6-week post-TQD, and 26-week post-TQD]

Self-reported 7-day point prevalence abstinence rates [Time Frame: 26 weeks post TQD]

Smoking reduction [Time Frame: 12 weeks post-TQD]

Feasibility: course evaluation [Time Frame: Up to 12 weeks post-TQD]

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

Smoking reduction [Time Frame: 6 weeks post-TQD]

Biochemically confirmed 7-day point prevalence abstinence from smoking [Time Frame: 2 weeks post-TQD]

Feasibility: Behavioral intervention used [Time Frame: 12 weeks post-TQD]

Changes in anxiety [Time Frame: Baseline to 2-week and 12-week post TQD]

Changes in depression [Time Frame: Baseline to 2-week and 12-week post TQD]

Feasibility: Side effects [Time Frame: 1-week post-TQD, 2-week post-TQD, and 6-week post-TQD]

Self-reported 7-day point prevalence abstinence rates [Time Frame: 12 weeks post TQD]

Smoking reduction [Time Frame: 26 weeks post-TQD]

Self-reported 7-day point prevalence abstinence rates [Time Frame: 1 week post TQD]

Secondary ID(s)

Pro00073392

P50DA027840

Source(s) of Monetary Support

Please refer to primary and secondary sponsors

Secondary Sponsor(s)

Alere Wellbeing

National Institute on Drug Abuse (NIDA)