Zonisamide/Bupropion Effects on Switching to Electronic Cigarettes (BuZonE)

• ClinicalTrials.gov Identifier: NCT04388319
• Recruitment Status: Completed
• First Posted: May 14, 2020
• Results First Posted: March 29, 2022
• Last Update Posted: April 13, 2022
• Sponsor: Rose Research Center, LLC
• Collaborator: Foundation for a Smoke Free World INC
• Information provided by (Responsible Party): Rose Research Center, LLC

Study Description

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).

Condition or disease	Intervention/treatment	Phase
Smoking Cessation	Drug: Zonisamide; Drug: Bupropion; Other: Halo G6 e-cigarette	Phase 3

Study Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 26 participants
• Allocation: N/A
• Intervention Model: Single Group Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: Zonisamide/Bupropion Effects on Switching to Electronic Cigarettes
• Actual Study Start Date: May 27, 2020
• Actual Primary Completion Date: June 4, 2021
• Actual Study Completion Date: September 15, 2021

Arms and Interventions

Arm

Intervention/treatment

Experimental: Combination zonisamide and bupropion with e-cigarette; 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; Zonisamide (100 mg/daily) for 12 weeks.; Other Name: zonegran; Drug: Bupropion; Extended-release bupropion dosing (150 mg each morning days 1-3, then 300 mg/daily) for the remainder of the 12 weeks.; Other Names: wellbutrin; Zyban; Other: Halo G6 e-cigarette; G6 e-cigarette for ad libitum use for two weeks prior to complete switch day.; Other Name: e-cigarette

Outcome Measures

Primary Outcome Measures :

1. 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) ]
   Defined as self-report of no cigarette smoking (not even a puff), confirmed by an expired air CO reading of less than 5 ppm.

Secondary Outcome Measures :

1. Point Abstinence From Combustible Cigarettes [ Time Frame: Six months post switch day (approximately 6 months post baseline) ]
   Assessed by self-report utilizing an automated SMS messaging system.
2. Change in Rewarding Effects of Smoking Combustible Cigarettes [ Time Frame: First week compared to after start of study drugs (Weeks 2-13 post baseline) ]
   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.

Eligibility Criteria

• Ages Eligible for Study: 21 Years to 65 Years (Adult, Older Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

Criteria

Inclusion Criteria:

1. Has signed the ICF and is able to read and understand the information provided in the ICF.
2. Is 21 to 65 years of age (inclusive) at screening.
3. Smokes at least 10 commercially available cigarettes per day (no brand restrictions), for the last 12 months.
4. Has an expired air CO reading of at least 10 ppm at screening.
5. Interested in switching to an electronic cigarette.
6. Willing and able to comply with the requirements of the study.
7. Owns a smart phone with text message and data capabilities compatible with necessary surveys.

Exclusion Criteria:

1. 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).
2. 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.
3. Planned use of an FDA-approved smoking cessation product during the study.
4. High blood pressure (systolic > 150 mmHg or diastolic >95 mmHg) at screening.
5. Body mass index (BMI) less than 15.0 kg/m2 or greater than 40.0 kg/m2.
6. 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.
7. Has received psychotherapy or behavioral treatments potentially impacting symptoms of depression, anxiety, or nicotine withdrawal within 30 days of screening, or during the study.
8. Taking antidepressants, psychoactive medications (e.g. antipsychotics, benzodiazepines, hypnotics) or medications that prolong QTc.

9. Use of any of these products in the past 30 days:

   1. Illegal drugs (or if the urine drug screen is positive for cocaine, THC, amphetamines, methamphetamines, or opiates);
   2. Experimental (investigational) drugs that are unknown to participant;
   3. Chronic opiate use.
10. 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.
11. Pregnant or nursing (by self-report) or has a positive pregnancy test.
12. Enrollment requirements met.

Contacts and Locations

Locations

United States, North Carolina

Rose Research Center

Charlotte, North Carolina, United States, 28262

Rose Research Center

Raleigh, North Carolina, United States, 27617

Sponsors and Collaborators

Rose Research Center, LLC

Foundation for a Smoke Free World INC

  Study Documents (Full-Text)

Documents provided by Rose Research Center, LLC:

Study Protocol and Statistical Analysis Plan  [PDF] February 16, 2021

More Information

• Responsible Party: Rose Research Center, LLC
• ClinicalTrials.gov Identifier: NCT04388319
• Other Study ID Numbers: BuZonE
• First Posted: May 14, 2020
• Results First Posted: March 29, 2022
• Last Update Posted: April 13, 2022
• Last Verified: March 2022

Individual Participant Data (IPD) Sharing Statement:

• Plan to Share IPD: No

• Studies a U.S. FDA-regulated Drug Product: Yes
• Studies a U.S. FDA-regulated Device Product: No
• Product Manufactured in and Exported from the U.S.: Yes

Keywords provided by Rose Research Center, LLC:

e-cigarette; zonisamide; bupropion; combustible cigarettes

Additional relevant MeSH terms:

Zonisamide; Bupropion; Antidepressive Agents, Second-Generation; Antidepressive Agents; Psychotropic Drugs; Dopamine Uptake Inhibitors; Neurotransmitter Uptake Inhibitors; Membrane Transport Modulators; Molecular Mechanisms of Pharmacological Action; Dopamine Agents; Neurotransmitter Agents; Physiological Effects of Drugs; Cytochrome P-450 CYP2D6 Inhibitors; Cytochrome P-450 Enzyme Inhibitors; Enzyme Inhibitors; Anticonvulsants; Calcium Channel Blockers; Calcium-Regulating Hormones and Agents