Effectiveness of Combination Varenicline and Oral Nicotine Replacement Therapy (COMBO)
Condition: Smoking Cessation
Intervention: Varenicline; Oral Nicotine Replacement Therapy (NRT); Medication Reminders; Tobacco Cessation Counseling
Intervention description: All participants will be offered a 13-week course of varenicline (including a 1 week titration period). Dosage and administration per manufacturer: 0.5mg once daily for days 1-3 and 0.5mg twice daily for days 4-7 encompass the titration period, then 1mg twice daily for 12 weeks. An additional 12 weeks of treatment is recommended for long-term abstinence.; Half of study participants will be randomly assigned to receive oral nicotine replacement therapy (4mg gum or 4mg lozenge, depending on preference; to be used every 1-2 hours as urges occur) in addition to varenicline.; Half of study participants will be randomly assigned to receive automated medication reminders via their smartphones.; All participants will be offered 6 weekly tobacco cessation counseling sessions with a Tobacco Treatment Specialist.
Intervention MeSH terms: Nicotine; Varenicline
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Factorial Assignment
Masking: None (Open Label)
Enrollment: 34.0
Sex: All
Minimum age: 18 Years
Maximum age: 65 Years
Healthy volunteers: Accepts Healthy Volunteers
Keywords: smoking cessation; varenicline; nicotine gum; nicotine lozenges; nicotine replacement therapy; adherence; mHealth

Summary:

      Varenicline is considered to be a first-line tobacco cessation treatment. Previous studies
      have evaluated the impact of the combination of varenicline and nicotine patches (versus
      varenicline alone) on smoking cessation, though findings have been equivocal. No studies to
      date have evaluated the combination of varenicline and oral nicotine replacement therapy
      (NRT; i.e., nicotine lozenges or gum). Nicotine lozenges and gum can provide acute relief
      during cravings and high risk situations, which offers individuals the flexibility to deliver
      nicotine when they need it most (in contrast with the continuous and passive delivery of
      nicotine offered via the patch). Prospective clinical trials are needed in real-world
      settings to determine whether the combination of varenicline and oral nicotine replacement
      therapy (i.e., lozenges, gum) is superior to varenicline alone for smoking cessation. The
      proposed pilot randomized trial would enroll 100 participants over 1 year (≈8 participants
      per month) utilizing a 2x2 factorial design. Twelve weeks of a pharmacological intervention
      [varenicline + oral NRT (VAR+N) vs. varenicline alone (VAR)] will be crossed with automated
      medication reminders (reminder messages vs. no reminder messages). All participants will
      receive an adapted version of the standard counseling offered through the Tobacco Treatment
      Research Program (TTRP).

      The primary outcomes will be biochemically-verified smoking cessation at 12 and 26 weeks
      following a scheduled quit attempt (1 week after enrollment). Smartphone-based ecological
      momentary assessment (EMA) will be employed to measure withdrawal symptoms, medication
      adherence, side effects, and adverse events using the Insight™ platform developed by the
      Stephenson Cancer Center (SCC) mHealth Shared Resource. This pilot study will provide
      information regarding the feasibility, acceptability, and preliminary efficacy of combination
      varenicline and oral NRT for smoking cessation, which will support an NIH funding application
      for a larger, adequately powered study.
    

Eligibility criteria:

        Inclusion Criteria:

          -  ≥ 18 years of age

          -  ≥ 6th grade English literacy

          -  agree to use personal or study-provided smartphone/applications

          -  agree to complete phone-based or in-person surveys throughout 26 week study

          -  expired CO > 6 ppm at baseline visit (suggesting current smoker)

          -  currently smoke ≥ 5 cigarettes per day

          -  willing to make quit attempt 7 days after baseline visit

        Exclusion Criteria:

          -  < 18 years of age

          -  history of seizures or allergic reaction to varenicline

          -  report current suicidality

          -  taking anti-depressants or anti-psychotic medications

          -  pregnant or planning to become pregnant

          -  currently breastfeeding