Zonisamide/Bupropion Effects on Switching to Electronic Cigarettes
Condition: Smoking Cessation
Intervention: Zonisamide; Bupropion; Halo G6 e-cigarette
Intervention description: Zonisamide (100 mg/daily) for 12 weeks.; Extended-release bupropion dosing (150 mg each morning days 1-3, then 300 mg/daily) for the remainder of the 12 weeks.; G6 e-cigarette for ad libitum use for two weeks prior to complete switch day.
Intervention MeSH terms: Zonisamide; Bupropion
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 26.0
Sex: All
Minimum age: 21 Years
Maximum age: 65 Years
Healthy volunteers: Accepts Healthy Volunteers
Keywords: e-cigarette; zonisamide; bupropion; combustible cigarettes

Summary:

      This single-group, small-scale, open-label study (N= 25 to 50) will evaluate the impact of
      combination zonisamide and bupropion on the process of switching from combustible cigarettes
      (CC) to an e-cigarette. There will be a data collection period of at least five days to
      obtain baseline data on use of combustible cigarettes. Participants enrolled in the study
      will receive a G6 e-cigarette at V2 for ad libitum use. After the first week of e-cigarette
      use, (at V3) participants will be given zonisamide (100 mg/daily) and will begin
      extended-release bupropion dosing (150 mg each morning days 1-3, then 300 mg/daily) in
      addition to continued use of the G6. At each visit, participants will receive enough
      zonisamide, bupropion, and Halo G6 cartomizers to last until their next study visit. Halo G6
      and combination zonisamide and bupropion use will continue until the participant returns for
      the End-of-Study visit (V7).
    

Eligibility criteria:

        Inclusion Criteria:

          1. Has signed the ICF and is able to read and understand the information provided in the
             ICF.

          2. Is 21 to 65 years of age (inclusive) at screening.

          3. Smokes at least 10 commercially available cigarettes per day (no brand restrictions),
             for the last 12 months.

          4. Has an expired air CO reading of at least 10 ppm at screening.

          5. Interested in switching to an electronic cigarette.

          6. Willing and able to comply with the requirements of the study.

          7. Owns a smart phone with text message and data capabilities compatible with necessary
             surveys.

        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. Planned use of an FDA-approved smoking cessation product during the study.

          4. High blood pressure (systolic > 150 mmHg or diastolic >95 mmHg) at screening.

          5. Body mass index (BMI) less than 15.0 kg/m2 or greater than 40.0 kg/m2.

          6. Coronary heart disease, structural cardiac disease (including, but not limited to
             valvular heart disease or cardiac murmurs), cardiac dysrhythmias, syncope, cardiac
             chest pain, or history of heart attack or heart failure.

          7. Has received psychotherapy or behavioral treatments potentially impacting symptoms of
             depression, anxiety, or nicotine withdrawal within 30 days of screening, or during the
             study.

          8. Taking antidepressants, psychoactive medications (e.g. antipsychotics,
             benzodiazepines, hypnotics) or medications that prolong QTc.

          9. Use of any of these products in the past 30 days:

               1. Illegal drugs (or if the urine drug screen is positive for cocaine, THC,
                  amphetamines, methamphetamines, or opiates);

               2. Experimental (investigational) drugs that are unknown to participant;

               3. Chronic opiate use.

         10. Use of smokeless tobacco (chewing tobacco, snuff), cigars (except for "Black & Mild"
             cigars or Cigarillos), pipes, hookah, e-cigarettes, nicotine replacement therapy or
             other smoking cessation treatments within 14 days of screening.

         11. Pregnant or nursing (by self-report) or has a positive pregnancy test.

         12. Enrollment requirements met.