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Zonisamide + Bupropion for Smoking Cessation

Phase 3

Recruiting

Research Sponsored by Rose Research Center, LLC

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Smokes at least 10 commercially available cigarettes per day (no brand restrictions), for the last 12 months.

Is 21 to 65 years of age (inclusive) at screening.

Timeline

Screening 3 weeks

Treatment Varies

Follow Up baseline, week 1, week 2, week 4, week 8, week 12

Awards & highlights

Study Summary

This trial will evaluate the impact of combining zonisamide and bupropion on the process of switching from 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 CCs. 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

Who is the study for?

This trial is for smokers aged 21-65 who smoke at least 10 cigarettes daily for the past year, want to switch to e-cigarettes, and can use a smartphone with text and data. Excluded are those with certain health issues like high blood pressure or heart disease, depression risks (PHQ-9 score >9), using other smoking cessation methods or psychoactive drugs, pregnant/nursing women, or anyone deemed unfit by medical staff.Check my eligibility

What is being tested?

The study tests if combining Zonisamide and Bupropion helps people switch from regular cigarettes to e-cigarettes. Participants will first use an e-cigarette alone then take either both drugs, one drug plus placebo, or double placebo alongside continued e-cigarette use over seven weeks in this three-group randomized double-blind trial.See study design

What are the potential side effects?

Possible side effects of Zonisamide include drowsiness, loss of appetite, dizziness; while Bupropion may cause insomnia, dry mouth, headaches. E-cigarettes might lead to throat irritation or coughing. Side effects vary among individuals.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I have been smoking at least 10 cigarettes daily for the past year.

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I am between 21 and 65 years old.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ baseline, week 1, week 2, week 4, week 8, week 12

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~baseline, week 1, week 2, week 4, week 8, week 12

This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline, week 1, week 2, week 4, week 8, week 12 for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Carbon monoxide

Complete Switching From Combustible Cigarettes to JUUL e-cigarette as measured by change in Total urinary 4-(methylnitrosamino)-1-(3-pyridyl)-1-butanol (NNAL)

Complete Switching From Combustible Cigarettes to JUUL e-cigarette as measured by change in self-report of daily cigarette and e-cigarette use

Secondary outcome measures

Smoke

Change in Smoking withdrawal symptoms

Other outcome measures

Seven-day point abstinence at 6 months post-switch

Tolerability of study drugs as measured by frequency of drug termination or drug non-adherence

Side effects data

From 2009 Phase 3 trial • 64 Patients • NCT00292461

10%

diplopia

rash

dizziness

insomnia

somnolence

anorexia

Abdominal distention

Mood altered

nystagmus

contusion

nausia

pruritus

Gait disturbance

Lumber contusion

Vision blurred

100%

80%

60%

40%

20%

Study treatment Arm

Lamotrigine

Zonegran

Trial Design

3Treatment groups

Experimental Treatment

Placebo Group

Group I: Combination zonisamide and bupropion with e-cigaretteExperimental Treatment3 Interventions

After the first week of e-cigarette use (JUUL), participants will be given bupropion (150 mg each morning for days 1-3, then 300 mg daily) with zonisamide (100 mg daily). The combination of zonisamide and bupropion use will continue for 7 weeks of treatment, and e-cigarette use will continue until the end of the study (an additional 4 weeks).

Group II: Bupropion with e-cigaretteExperimental Treatment3 Interventions

After the first week of e-cigarette use (JUUL), participants will be given bupropion (150 mg each morning for days 1-3, then 300 mg daily) with placebo zonisamide. The combination of placebo and bupropion use will continue for 7 weeks of treatment, and e-cigarette use will continue until the end of the study (an additional 4 weeks).

Group III: Placebo with e-cigarettePlacebo Group3 Interventions

After the first week of e-cigarette use (JUUL), participants will be given placebo bupropion with placebo zonisamide. The combination of these placebos will continue for 7 weeks of treatment, and e-cigarette use will continue until the end of the study (an additional 4 weeks).

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Bupropion

FDA approved

Zonisamide

FDA approved

0 / 2Eligibility criteria met

Find a Location

Who is running the clinical trial?

Foundation for a Smoke-Free WorldOTHER

9 Previous Clinical Trials

898 Total Patients Enrolled

Rose Research Center, LLCLead Sponsor

15 Previous Clinical Trials

1,277 Total Patients Enrolled

Foundation for a Smoke Free World INCOTHER

14 Previous Clinical Trials

1,969 Total Patients Enrolled

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

What is the Zonisamide approval status with the FDA?

"Zonisamide has undergone multiple rounds of clinical trials, indicating that it is a safe medication with some efficacy. Our team ranks it as a 3 on our safety scale."

Answered by AI

Are test subjects of this trial restricted to those above 25 years old?

"The target participants for this trial are young adults, aged 21 to 65."

Answered by AI

Are there any medical conditions which would make someone ineligible for this research?

"This study is investigating smoking cessation techniques, and as such, participants must be smokers that are aged 21 to 65. Around 180 people will be accepted into the trial."

Answered by AI

Is recruitment still underway for patients to participate in this research?

"That is correct. The listing for the trial on clinicaltrials.gov shows that it is still seeking participants, with 180 patients needed at 2 locations. The study was first posted on December 14th, 2021 and last updated on August 22nd, 2022."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

The Effects of Combination Zonisamide and Bupropion on Switching to an Electronic Cigarette

2021. "The Effects of Combination Zonisamide and Bupropion on Switching to an Electronic Cigarette". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05205811.

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