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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.

Must not have

Has plans to use an FDA-approved smoking cessation product during the study.

Has 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.

Timeline

Screening 3 weeks

Treatment Varies

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

Awards & highlights

All Individual Drugs Already Approved

Approved for 5 Other Conditions

Pivotal Trial

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.

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.

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.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I plan to use an FDA-approved product to quit smoking during the study.

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I have a history of heart disease or issues like heart attack or failure.

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I have not had therapy for depression, anxiety, or nicotine withdrawal in the last 30 days.

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I have not used illegal drugs, experimental drugs, or chronic opiates in the last 30 days.

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I am currently taking antidepressants or medications for my mental health.

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

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

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 study objectives

Smoke

Change in Smoking withdrawal symptoms

Other study objectives

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

dizziness

rash

insomnia

somnolence

pruritus

Abdominal distention

anorexia

contusion

Mood altered

nystagmus

nausia

Gait disturbance

Lumber contusion

Vision blurred

100%

80%

60%

40%

20%

Study treatment Arm

Lamotrigine

Zonegran

Awards & Highlights

All Individual Drugs Already Approved

Therapies where all constituent drugs have already been approved are likely to have better-understood side effect profiles.

Approved for 5 Other Conditions

This treatment demonstrated efficacy for 5 other conditions.

Pivotal Trial

The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.

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 / 7Eligibility criteria met