Clinical trial NCT02840435: Study on Sit to Quit Phone Intervention
Official title: Pilot Study on Mindfulness Training for Smokers Via Web-based Video and Telephone Counseling
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Nicotine Dependence
Keywords: Nicotine addiction
Cigarette smoking
Lead sponsor: Duke University
Sponsor class: OTHER
Collaborators: name: Consumer Wellness Solutions
name: National Institute on Drug Abuse (NIDA)
First posted: 2016-07-21
Enrollment: 23
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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.

Eligibility 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.

Primary outcomes:
measure: Biochemically confirmed continuous 30-day abstinence from smoking
timeFrame: 12 weeks post-Target Quit Day (TQD)
Secondary outcomes:
measure: Biochemically confirmed 7-day point prevalence abstinence from smoking
timeFrame: 12 weeks post-TQD
measure: Biochemically confirmed 7-day point prevalence abstinence from smoking
timeFrame: 2 weeks post-TQD
measure: Self-reported 7-day point prevalence abstinence rates
timeFrame: 1 week post TQD
measure: Self-reported 7-day point prevalence abstinence rates
timeFrame: 12 weeks post TQD
measure: Self-reported 7-day point prevalence abstinence rates
timeFrame: 26 weeks post TQD
measure: Self-reported 7-day point prevalence abstinence rates
timeFrame: 6 weeks post TQD
measure: Self-reported 7-day point prevalence abstinence rates
timeFrame: 2 weeks post TQD
measure: Smoking reduction
timeFrame: 1 week post-TQD
measure: Smoking reduction
timeFrame: 2 weeks post-TQD
measure: Smoking reduction
timeFrame: 6 weeks post-TQD
measure: Smoking reduction
timeFrame: 12 weeks post-TQD
measure: Smoking reduction
timeFrame: 26 weeks post-TQD
measure: Changes in stress
timeFrame: Baseline to 2-week and 12-week post TQD
measure: Changes in anxiety
timeFrame: Baseline to 2-week and 12-week post TQD
measure: Changes in depression
timeFrame: Baseline to 2-week and 12-week post TQD
measure: Changes in relapse predictors
timeFrame: Baseline to 1-week post-TQD, 2-week post-TQD, 6-week post-TQD, 12-week post-TQD, and 26-week post-TQD
measure: Feasibility: attendance records
timeFrame: Up to 12 weeks post-TQD
measure: Feasibility: website usage
timeFrame: Up to 12 weeks post-TQD
measure: Feasibility: course evaluation
timeFrame: Up to 12 weeks post-TQD
measure: Feasibility: demographics
timeFrame: 12-weeks post-TQD
measure: Feasibility: Behavioral intervention used
timeFrame: 12 weeks post-TQD
measure: Feasibility: Attendance at DSCP appointments
timeFrame: 12 weeks post-TQD
measure: Feasibility: Referral routes to DSCP
timeFrame: Baseline
measure: Feasibility: Side effects
timeFrame: 1-week post-TQD, 2-week post-TQD, and 6-week post-TQD
measure: Feasibility: medication adherence
timeFrame: 1-week post-TQD, 2-week post-TQD, 6-week post-TQD, and 26-week post-TQD
measure: Feasibility: mindfulness practices
timeFrame: 1-week post-TQD, 2-week post-TQD, 6-week post-TQD, and 26-week post-TQD
measure: Feasibility: meditation time
timeFrame: 1-week post-TQD, 2-week post-TQD, 6-week post-TQD, and 26-week post-TQD
Other outcomes:
Locations:
city: Durham
country: United States
facility: Duke Center for Smoking Cessation
state: North Carolina
Study officials:
affiliation: Duke University
name: James M Davis, MD
role: PRINCIPAL_INVESTIGATOR
References: