Efficacy and Tolerability of Combination Varenicline With Hydroxyzine as a Potential Smoking Cessation Treatment
Condition: Smoking Cessation; Stress; Sleep Disturbance; Nausea
MeSH terms: Dyssomnias; Parasomnias
Intervention: Varenicline Pill; Hydroxyzine Pill
Intervention description: FDA approved starter kit of varenicline (0.5 mg nightly for days 1-3, then 0.5 mg twice daily for days 4-7) followed by FDA-approved dose of varenicline (1 mg twice daily) for the remaining 11 weeks; For the first week, participants will receive 50 mg nightly for the first 3 days, then twice daily, 25 mg in the morning and 50 mg at night for the remaining 12 weeks.
Intervention MeSH terms: Hydroxyzine; Varenicline
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Intervention model description: Open-label, single group study.
Masking: None (Open Label)
Enrollment: 26.0
Sex: All
Minimum age: 19 Years
Maximum age: 65 Years
Healthy volunteers: Accepts Healthy Volunteers

Summary:

      This open-label study will evaluate hydroxyzine, a first-generation antihistamine, combined
      with varenicline, to help smokers abstain from smoking during a 12-week trial period by
      diminishing the nausea, stress, anxiety, and sleep disturbances associated with the use of
      varenicline and with nicotine withdrawal.
    

Eligibility criteria:

        Inclusion Criteria:

          1. Has signed the consent form and is able to read and understand the information
             provided in the consent form.

          2. Is 19 to 65 years of age (inclusive) at screening.

          3. Smokes at least 10 commercially available cigarettes per day for the last 12 months.

          4. Has an expired air carbon monoxide reading of at least 10 ppm at screening.

          5. Express a desire to quit smoking within the next 30 days at screening.

          6. Willing and able to comply with the requirements of the study.

          7. Participant owns a smart phone with text message and data capabilities.

        Exclusion Criteria:

          1. Is unhealthy or cannot participate in the study for any reason (e.g., medical,
             psychiatric, and/or social reason) as judged by the Investigator or designated medical
             staff based on all available assessments from the screening period (e.g., safety
             laboratory, vital signs, physical examination, ECG, concomitant medications and
             medical history).

          2. PHQ-9 score greater than 9, or a score greater than 0 on item #9 ("Thoughts that you
             would be better off dead, or of hurting yourself in some way") at screening.

          3. High blood pressure (systolic > 150 mmHg or diastolic >95 mmHg) at screening.

          4. Body mass index (BMI) less than 15.0 kg/m2 or greater than 40.0 kg/m2.

          5. Coronary heart disease, structural cardiac disease, cardiac dysrhythmias, abnormal ECG
             (e.g. prolonged QTc), syncope, cardiac chest pain, or history of heart attack or heart
             failure.

          6. Has received psychotherapy or behavioral treatments potentially impacting symptoms of
             depression, anxiety, or nicotine withdrawal within 30 days of screening, or during the
             study.

          7. Taking antidepressants, psychoactive medications (e.g. antipsychotics,
             benzodiazepines, hypnotics) or medications that prolong QTc.

          8. Positive urine drug test for cocaine, marijuana, opiates, amphetamines or
             methamphetamines.

          9. Use of smokeless tobacco (chewing tobacco, snuff), cigars, pipes, hookah,
             e-cigarettes, nicotine replacement therapy or other smoking cessation treatments
             within 14 days of enrollment.

         10. Pregnant or nursing (by self-report) or has a positive pregnancy test.