Study on Sit to Quit Phone Intervention

Duke University

Status

Completed

Conditions

Nicotine Dependence

Treatments

Behavioral: Sit to Quit

Behavioral: Quit for Life

Study type

Interventional

Funder types

Other

Industry

NIH

Identifiers

NCT02840435

P50DA027840 (U.S. NIH Grant/Contract)

Pro00073392

Details and patient eligibility

About

Full 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.

Enrollment

23 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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.