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Completed

NCT Number: NCT04388319

Zonisamide/Bupropion Effects on Switching to Electronic Cigarettes

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).

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Key information

Age range

21 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Rose Research Center, Charlotte, North Carolina, United States

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Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Has signed the ICF and is able to read and understand the information provided in the ICF.
  • Is 21 to 65 years of age (inclusive) at screening.
  • Smokes at least 10 commercially available cigarettes per day (no brand restrictions), for the last 12 months.
  • Has an expired air CO reading of at least 10 ppm at screening.
  • Interested in switching to an electronic cigarette.
  • Willing and able to comply with the requirements of the study.
  • Owns a smart phone with text message and data capabilities compatible with necessary surveys.

Exclusion criteria

  • 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).
  • 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.
  • Planned use of an FDA-approved smoking cessation product during the study.
  • High blood pressure (systolic > 150 mmHg or diastolic >95 mmHg) at screening.
  • Body mass index (BMI) less than 15.0 kg/m2 or greater than 40.0 kg/m2.
  • 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.
  • Has received psychotherapy or behavioral treatments potentially impacting symptoms of depression, anxiety, or nicotine withdrawal within 30 days of screening, or during the study.
  • Taking antidepressants, psychoactive medications (e.g. antipsychotics, benzodiazepines, hypnotics) or medications that prolong QTc.
  • Use of any of these products in the past 30 days:
  • Illegal drugs (or if the urine drug screen is positive for cocaine, THC, amphetamines, methamphetamines, or opiates);
  • Experimental (investigational) drugs that are unknown to participant;
  • Chronic opiate use.
  • 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.
  • Pregnant or nursing (by self-report) or has a positive pregnancy test.
  • Enrollment requirements met.

Treatment and study plan

zonisamide

Drug

Zonisamide (100 mg/daily) for 12 weeks.

Other names: zonegran

bupropion

Drug

Extended-release bupropion dosing (150 mg each morning days 1-3, then 300 mg/daily) for the remainder of the 12 weeks.

Other names: wellbutrin, Zyban

Halo G6 e-cigarette

Other

G6 e-cigarette for ad libitum use for two weeks prior to complete switch day.

Other names: e-cigarette

Primary outcomes

  1. Number of Participants That Completely Switched From Combustible Cigarettes to Halo G6 E-Cigarettes

    Time frame: Weeks 8-11 post-quit date (weeks 10-13 post baseline)

    Defined as self-report of no cigarette smoking (not even a puff), confirmed by an expired air CO reading of less than 5 ppm.

Secondary outcomes

  1. Point Abstinence From Combustible Cigarettes

    Time frame: Six months post switch day (approximately 6 months post baseline)

    Assessed by self-report utilizing an automated SMS messaging system.

  2. Change in Rewarding Effects of Smoking Combustible Cigarettes

    Time frame: First week compared to after start of study drugs (Weeks 2-13 post baseline)

    Characterize changes in the two primary scales of the Cigarette Evaluation Questionnaire (mCEQ), assessing smoking satisfaction and psychological reward, compared between cigarettes smoked after meals versus all others smoked during the day, examining how this difference changes after zonisamide/bupropion usage. The mCEQ uses a 7-point scale (0=Not at all; 1=Very little; 2=A little; 3=Moderately; 4=A lot, 5=Quite a lot; 6=Extremely) to measure the following subscales: Satisfaction, Psychological Reward, Enjoyment of Respiratory Tract Sensations, Craving Reduction, Aversion.

Sponsors and collaborators

Lead sponsor

Rose Research Center, LLC

Industry

Collaborators

  • Foundation for a Smoke Free World INC

Registry information

Acronym: BuZonE

Important dates

Study start
2020
Primary completion
2021
Study completion
2021
First posted
May 14, 2020
Registry last updated
Apr 13, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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