A Comparison of the Effectiveness of Combination Varenicline and Oral Nicotine Replacement Therapy Versus Varenicline Alone for Smoking Cessation: a Pilot Study

Tobacco Treatment Research Program (TTRP).The TTRP led by Dr. Darla Kendzor and located at the University of Oklahoma Health Science Center (OUHSC), offers free tobacco cessation treatment to adults from campus or the community who would like to quit using tobacco. The proposed study would take place within the context of the TTRP. Individuals are linked with the TTRP via the electronic medical record and 1-click referrals from clinical departments at the OUHSC or SCC; or from the community by phone [(405) 271-QUIT (7848)], email (ttrp@ouhsc.edu), or fax referrals. Treatment includes counseling with a Tobacco Treatment Specialist either in-person or over the telephone and pharmacological treatment.

Baseline (1-Week Pre-quit; Visit 1):

Informed Consent/Screening. Informed consent will be obtained from all participants in a private room in the TTRP. Individuals will be included in the study if they: 1) are ≥ 18 years of age, 2) demonstrate > 6th grade English literacy level, 3) agree to install the study smartphone application onto their personal phone (or agree to carry a study-provided phone with the app), 4) agree to complete phone-based or in-person surveys through 26 weeks post-quit date, 5) have an expired CO level > 7 ppm at the baseline screening visit suggestive of current smoking, 6) currently smoke ≥ 5 cigarettes per day, 7) are willing to initiate a quit attempt 7 days after the baseline visit (enrollment). Individuals will be excluded from the study if they 1) have a history of seizures or allergic reaction to varenicline, 2) report current suicidality, 3) are taking anti-depressant or anti-psychotic medications, or 4) are pregnant, planning to become pregnant, or currently breastfeeding. Please note that the smartphone application used in this pilot study is only available in English.

Smartphones. Participants will be guided through the process of downloading the InsightTM smartphone application onto their personal smartphone and they will be asked to complete daily EMAs during the 12 week period when they are taking their study medication(s). Those who do not possess a phone that meets the minimum requirements to download the Insight™ app, will be provided with a study phone. The smartphone app home screen will include: 1) a "Call Staff" function/button that automatically calls study staff when participants have problems with the app, and 2) a "Payment" function/button that enables participants to track their current level of compliance with phone-based surveys and level of compensation. At the baseline visit, all participants will receive training about how to use the smartphone app to complete EMA and how to use the "Call Staff" and "Payment" button/options. Participants will be instructed to quit smoking at bedtime or 10:00 pm (whichever occurs first), 6 days following their Baseline session. The app will remind participants about their approaching quit date during each day of the pre-cessation period.

Questionnaires and Other Measures. Participants will complete self-report questionnaires on a tablet computer; and expired CO, weight, and height will be measured in a private room to ensure confidentiality.