- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04388319
Zonisamide/Bupropion Effects on Switching to Electronic Cigarettes (BuZonE)
March 28, 2022 updated by: Rose Research Center, LLC
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).
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
26
Phase
- Phase 3
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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North Carolina
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Charlotte, North Carolina, United States, 28262
- Rose Research Center
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Raleigh, North Carolina, United States, 27617
- Rose Research Center
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
21 years to 65 years (ADULT, OLDER_ADULT)
Accepts Healthy Volunteers
Yes
Genders Eligible for Study
All
Description
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.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: TREATMENT
- Allocation: NA
- Interventional Model: SINGLE_GROUP
- Masking: NONE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
EXPERIMENTAL: Combination zonisamide and bupropion with e-cigarette
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 and bupropion in addition to continued use of the G6.
Use of these study drugs will continue for 12- weeks with a target complete switch date (from combustible cigarettes to e-cigarettes) one week after study drug initiation.
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Zonisamide (100 mg/daily) for 12 weeks.
Other Names:
Extended-release bupropion dosing (150 mg each morning days 1-3, then 300 mg/daily) for the remainder of the 12 weeks.
Other Names:
G6 e-cigarette for ad libitum use for two weeks prior to complete switch day.
Other Names:
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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)
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Defined as self-report of no cigarette smoking (not even a puff), confirmed by an expired air CO reading of less than 5 ppm.
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Weeks 8-11 post-quit date (weeks 10-13 post baseline)
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Point Abstinence From Combustible Cigarettes
Time Frame: Six months post switch day (approximately 6 months post baseline)
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Assessed by self-report utilizing an automated SMS messaging system.
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Six months post switch day (approximately 6 months post baseline)
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Change in Rewarding Effects of Smoking Combustible Cigarettes
Time Frame: First week compared to after start of study drugs (Weeks 2-13 post baseline)
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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.
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First week compared to after start of study drugs (Weeks 2-13 post baseline)
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Collaborators
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (ACTUAL)
May 27, 2020
Primary Completion (ACTUAL)
June 4, 2021
Study Completion (ACTUAL)
September 15, 2021
Study Registration Dates
First Submitted
May 11, 2020
First Submitted That Met QC Criteria
May 11, 2020
First Posted (ACTUAL)
May 14, 2020
Study Record Updates
Last Update Posted (ACTUAL)
April 13, 2022
Last Update Submitted That Met QC Criteria
March 28, 2022
Last Verified
March 1, 2022
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Physiological Effects of Drugs
- Neurotransmitter Agents
- Molecular Mechanisms of Pharmacological Action
- Enzyme Inhibitors
- Psychotropic Drugs
- Neurotransmitter Uptake Inhibitors
- Membrane Transport Modulators
- Antidepressive Agents
- Dopamine Agents
- Cytochrome P-450 Enzyme Inhibitors
- Anticonvulsants
- Antidepressive Agents, Second-Generation
- Cytochrome P-450 CYP2D6 Inhibitors
- Calcium-Regulating Hormones and Agents
- Calcium Channel Blockers
- Dopamine Uptake Inhibitors
- Bupropion
- Zonisamide
Other Study ID Numbers
- BuZonE
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Yes
Studies a U.S. FDA-regulated device product
No
product manufactured in and exported from the U.S.
Yes
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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