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Smoking CessationPhase 3BuZonENCT04388319

Zonisamide/Bupropion Effects on Switching to Electronic Cigarettes

A Phase 3 study testing Zonisamide, Bupropion and Halo G6 e-cigarette in people with Smoking Cessation, run by Rose Research Center, LLC at 2 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 21 to 65 yearsHealthy volunteers can take part
Conditions the study is for
Smoking Cessation
What is being tested?
Zonisamide, Bupropion and Halo G6 e-cigarette
Could I receive a placebo?
No, everyone receives an active treatment
How many people
26 participants
Where
2 sitesUnited States
Study dates
27 May 2020to 15 Sep 2021
Phase
Phase 3
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 21 to 65 years
  • All sexes
  • Healthy volunteers accepted
  • Adult, Older adult

Who may be able to join

  • 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.

Who cannot join

  • 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.
Show all 15Show fewer
  • 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.

Trial locations and contacts

2 sites in 1 country.

United States2 sites

  • Rose Research Center

    Charlotte, North Carolina, 28262

  • Rose Research Center

    Raleigh, North Carolina, 27617

Other trials in United States

About this study

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).

Being tested
Zonisamide, Bupropion, Halo G6 e-cigarette
Keywords
e-cigarette, zonisamide, bupropion, combustible cigarettes
Medical subject headings
Smoking Cessation, Vaping

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • ZonisamideDrug

    Also called zonegran

    Zonisamide (100 mg/daily) for 12 weeks.

  • BupropionDrug

    Also called wellbutrin, Zyban

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

  • Halo G6 e-cigaretteOther

    Also called e-cigarette

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

Study groups in NCT04388319
Study groupRoleWhat they receive
Combination zonisamide and bupropion with e-cigaretteExperimentalParticipants 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.
Receives: Drug: Zonisamide; Drug: Bupropion; Other: Halo G6 e-cigarette

What is being measured

The primary outcome is the main question the study is designed to answer.

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

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

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

Secondary outcomes (2)

  1. Point Abstinence From Combustible Cigarettes

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

    Measured: Six months post switch day (approximately 6 months post baseline)

  2. Change in Rewarding Effects of Smoking Combustible Cigarettes

    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.

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

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted14 May 2020
  2. Study start27 May 2020
  3. Primary completion4 Jun 2021
  4. Study completion15 Sep 2021

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
26 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04388319
Sponsor's protocol ID
BuZonE
Acronym
BuZonE
Status last verified
Mar 2022
First submitted
11 May 2020
Last updated
13 Apr 2022
Data monitoring committee
No
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Zonisamide, Bupropion and Halo G6 e-cigarette in people with Smoking Cessation, run by Rose Research Center, LLC at 2 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 7 inclusion and 15 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 13 Apr 2022. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 29 Mar 2022). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

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)). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04388319.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Apr 2022.

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