Zonisamide/Bupropion Effects on Switching to Electronic Cigarettes

NCT04388319 | Completed Phase 3 Results FDA Drug

• 1 other identifier: BuZonE
• Study Type: interventional
• Target: 26
• Locations: 1 country
• Sites: 2

Brief 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. 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).

Conditions

Smoking Cessation

Keywords

e-cigarette; zonisamide; bupropion; combustible cigarettes

Outcome Measures

Primary Outcomes (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.

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

Secondary Outcomes (2)

• Point Abstinence From Combustible Cigarettes

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

• Change in Rewarding Effects of Smoking Combustible Cigarettes

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

Study Arms (1)

Combination zonisamide and bupropion with e-cigarette

EXPERIMENTAL

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.

Drug: Zonisamide; Drug: Bupropion; Other: Halo G6 e-cigarette

Interventions

Zonisamide DRUG

Zonisamide (100 mg/daily) for 12 weeks.

Also known as: zonegran

Combination zonisamide and bupropion with e-cigarette

Bupropion DRUG

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

Also known as: wellbutrin, Zyban

Combination zonisamide and bupropion with e-cigarette

Halo G6 e-cigarette OTHER

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

Also known as: e-cigarette

Combination zonisamide and bupropion with e-cigarette

Eligibility Criteria

• Age: 21 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Rose Research Center, LLC: lead
• Foundation for a Smoke Free World INC: collaborator

Study Sites (2)

Rose Research Center

Charlotte, North Carolina, 28262, United States

Location

Rose Research Center

Raleigh, North Carolina, 27617, United States

Location

MeSH Terms

Conditions

Smoking Cessation; Vaping

Interventions

Zonisamide; Bupropion; Electronic Nicotine Delivery Systems

Condition Hierarchy (Ancestors)

Health Behavior; Behavior; Smoking

Intervention Hierarchy (Ancestors)

Sulfonamides; Amides; Organic Chemicals; Sulfones; Sulfur Compounds; Isoxazoles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Propiophenones; Ketones; Smoking Devices; Manufactured Materials; Technology, Industry, and Agriculture

Results Point of Contact

• Title: Dr. Jed E. Rose
• Organization: Rose Research Center

jed.rose@roseresearchcenter.com

9193282345

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 11, 2020
• First Posted: May 14, 2020
• Study Start: May 27, 2020
• Primary Completion: June 4, 2021
• Study Completion: September 15, 2021
• Last Updated: April 13, 2022
• Results First Posted: March 29, 2022

Record last verified: 2022-03

Data Sharing

• IPD Sharing: Will not share

Locations

US (2)