This three-group randomized double-blind placebo-controlled trial (N=180) will evaluate the impact of combination zonisamide and bupropion on the process of switching from combustible cigarettes (CCs) to an e-cigarette. There will be a data collection period of at least five days to obtain baseline information on the use of combustible cigarettes. All participants enrolled in the study will receive a JUUL e-cigarette at Visit 2 for ad libitum use. After the first week of e-cigarette use (at Visit 3), participants will be given bupropion (150 mg each morning for days 1-3, then 300 mg daily) with either zonisamide (100 mg daily) or placebo (group 1 and group 2 respectively), or placebo for both medications (group 3) in addition to continued use of the e-cigarette. At each visit, participants will receive enough study drugs (or placebos) and e-cigarettes to last until their next study visit. The combination of zonisamide and bupropion use will continue until Visit 6 (7 weeks of treatment), and e-cigarette use will continue until the end of treatment (Visit 7).
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
180
Extended-release bupropion dosing (150 mg each morning days 1-3, then 300 mg/daily) for the remainder of the 7 weeks.
Zonisamide (100 mg/daily) for 7 weeks.
Placebo bupropion for 7 weeks.
Placebo zonisamide for 7 weeks.
e-cigarette for ad libitum use for two weeks prior to complete switch day and for an additional 10 weeks.
Rose Research Center
Charlotte, North Carolina, United States
Rose Research Center
Raleigh, North Carolina, United States
Complete Switching From Combustible Cigarettes to JUUL e-cigarette as measured by Exhaled carbon monoxide (CO)
Exhaled carbon monoxide (CO) \< 5 ppm at the end of drug treatment
Time frame: After 8 weeks
Complete Switching From Combustible Cigarettes to JUUL e-cigarette as measured by change in Total urinary 4-(methylnitrosamino)-1-(3-pyridyl)-1-butanol (NNAL)
Total urinary 4-(methylnitrosamino)-1-(3-pyridyl)-1-butanol (NNAL)
Time frame: Baseline, Week 8, Week 12
Complete Switching From Combustible Cigarettes to JUUL e-cigarette as measured by change in self-report of daily cigarette and e-cigarette use
Self-report of daily cigarette and e-cigarette use
Time frame: Daily from Week 2 to Week 12
Change in Smoking withdrawal symptoms
Smoking withdrawal symptoms will be collected using a questionnaire developed by Drs. Shiffman and Jarvik (1976), which assesses craving for cigarettes, negative mood, arousal, missing the habit of smoking, changes in appetite and somatic symptoms and a seven-point scale (from 1-Not at All to 7-Extremely). Higher scores indicate more withdrawal symptoms.
Time frame: Baseline, Week 1, Week 2, Week 4, Week 8, Week 12
Change in Rewarding and aversive effects of smoking and e-cigarette use
The mCEQ-E will be utilized to assess the degree to which participants experience the reinforcing of smoking, providing five subscale scores: smoking satisfaction (satisfying, tastes good,enjoy smoking), psychological rewards (calms down, more awake, less irritable, helps concentrate, reduces hunger), aversion (dizziness, nauseated), enjoyment of respiratory tract sensations (single-item assessment), craving reduction (single-item assessment). Participants will be asked to assess the 12 items of the questionnaire on a 7-point scale, ranging from "not at all" to "extremely". These 12 items will be asked for the "first cigarette smoked", "cigarette immediately after a meal", and "all other cigarettes." The e-cigarette version of this questionnaire (mECEQ-E) will also be used.
Time frame: Baseline, Week 1, Week 2, Week 4, Week 8, Week 12
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