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Zonisamide for Smoking Cessation

Rose Research Center, Charlotte, NC
Smoking CessationZonisamide - Drug
Eligibility
21 - 65
All Sexes

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

Treatment Effectiveness

Phase-Based Effectiveness

2 of 3
Phase 3
This is further along than 85% of similar trials

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Usual health education curriculum
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Tobacco flavored liquid type 1

Study Objectives

3 Primary · 2 Secondary · Reporting Duration: Baseline, Week 1, Week 2, Week 4, Week 8, Week 12

Month 6
Seven-day point abstinence at 6 months post-switch
After 8 weeks
Carbon monoxide
Week 8
Tolerability of study drugs as measured by frequency of drug termination or drug non-adherence
Week 12
Smoke
Change in Smoking withdrawal symptoms
Week 12
Complete Switching From Combustible Cigarettes to JUUL e-cigarette as measured by change in Total urinary 4-(methylnitrosamino)-1-(3-pyridyl)-1-butanol (NNAL)
Week 12
Complete Switching From Combustible Cigarettes to JUUL e-cigarette as measured by change in self-report of daily cigarette and e-cigarette use

Trial Safety

Phase-Based Safety

3 of 3
This is further along than 85% of similar trials

Similar Trials

1
CATCH My Breath (CMB) program for E-cigarette prevention among adolescents
1
Usual health education curriculum
1
Tobacco flavored liquid type 1

Side Effects for

Lamotrigine
10%diplopia
7%somnolence
7%dizziness
7%rash
7%insomnia
3%nausia
3%anorexia
3%nystagmus
3%Gait disturbance
3%Abdominal distention
3%contusion
3%Lumber contusion
3%Mood altered
3%pruritus
3%Vision blurred
This histogram enumerates side effects from a completed 2009 Phase 3 trial (NCT00292461) in the Lamotrigine ARM group. Side effects include: diplopia with 10%, somnolence with 7%, dizziness with 7%, rash with 7%, insomnia with 7%.

Awards & Highlights

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

Trial Design

3 Treatment Groups

Combination zonisamide and bupropion with e-cigarette
1 of 3
Bupropion with e-cigarette
1 of 3
Placebo with e-cigarette
1 of 3

Experimental Treatment

Non-Treatment Group

180 Total Participants · 3 Treatment Groups

Primary Treatment: Zonisamide · Has Placebo Group · Phase 3

Combination zonisamide and bupropion with e-cigaretteExperimental Group · 3 Interventions: Zonisamide, Bupropion, E-cigarette · Intervention Types: Drug, Drug, Other
Bupropion with e-cigaretteExperimental Group · 3 Interventions: Bupropion, E-cigarette, Placebo zonisamide · Intervention Types: Drug, Other, Drug
Placebo with e-cigarettePlaceboComparator Group · 3 Interventions: E-cigarette, Placebo bupropion, Placebo zonisamide · Intervention Types: Other, Drug, Drug
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Zonisamide
2006
Completed Phase 4
~2280
Bupropion
2011
Completed Phase 4
~3310

Trial Logistics

Trial Timeline

Screening: ~3 weeks
Treatment: Varies
Reporting: baseline, week 1, week 2, week 4, week 8, week 12

Who is running the clinical trial?

Foundation for a Smoke Free World INCOTHER
11 Previous Clinical Trials
1,215 Total Patients Enrolled
Rose Research Center, LLCLead Sponsor
12 Previous Clinical Trials
561 Total Patients Enrolled
Foundation for a Smoke-Free WorldOTHER
9 Previous Clinical Trials
932 Total Patients Enrolled

Eligibility Criteria

Age 21 - 65 · All Participants · 2 Total Inclusion Criteria

Mark “Yes” if the following statements are true for you:
You want to start using electronic cigarettes.
You smoke at least 10 cigarettes a day for the past year.
References

Frequently Asked Questions

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." - Anonymous Online Contributor

Unverified Answer

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." - Anonymous Online Contributor

Unverified Answer

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." - Anonymous Online Contributor

Unverified Answer

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." - Anonymous Online Contributor

Unverified Answer
Please Note: These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

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