Smoking Cessation
Conditions
Keywords
e-cigarette, zonisamide, bupropion, combustible cigarettes
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).
Interventions
DRUGZonisamide
Zonisamide (100 mg/daily) for 12 weeks.
DRUGBupropion
Extended-release bupropion dosing (150 mg each morning days 1-3, then 300 mg/daily) for the remainder of the 12 weeks.
OTHERHalo G6 e-cigarette
G6 e-cigarette for ad libitum use for two weeks prior to complete switch day.
Sponsors
Foundation for a Smoke Free World INC
Rose Research Center, LLC
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
21 Years to 65 Years
Healthy volunteers
Yes
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants That Completely Switched From Combustible Cigarettes to Halo G6 E-Cigarettes | 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
| Measure | Time frame | Description |
|---|---|---|
| Point Abstinence From Combustible Cigarettes | Six months post switch day (approximately 6 months post baseline) | Assessed by self-report utilizing an automated SMS messaging system. |
| Change in Rewarding Effects of Smoking Combustible Cigarettes | 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. |
Countries
United States
Participant flow
Pre-assignment details
Two participants were enrolled into the study but discontinued prior to taken any study drug.
Participants by arm
| Arm | Count |
|---|---|
| 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.
Zonisamide: Zonisamide (100 mg/daily) for 12 weeks.
Bupropion: Extended-release bupropion dosing (150 mg each morning days 1-3, then 300 mg/daily) for the remainder of the 12 weeks.
Halo G6 e-cigarette: G6 e-cigarette for ad libitum use for two weeks prior to complete switch day. | 26 |
| Total | 26 |
Baseline characteristics
| Characteristic | Combination Zonisamide and Bupropion With E-cigarette |
|---|---|
| Age, Categorical <=18 years | 0 Participants |
| Age, Categorical >=65 years | 0 Participants |
| Age, Categorical Between 18 and 65 years | 26 Participants |
| Age, Continuous | 45.1 years STANDARD_DEVIATION 9.75 |
| Cigarettes smoked per day (CPD) | 21.2 Cigs smoked per day STANDARD_DEVIATION 6.64 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 1 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 25 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants |
| Expired air carbon monoxide (CO) | 26.0 ppm STANDARD_DEVIATION 9.19 |
| FTND -- The Fagerström Test for Nicotine Dependence Score | 6.1 units on a scale STANDARD_DEVIATION 1.82 |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants |
| Race (NIH/OMB) Asian | 1 Participants |
| Race (NIH/OMB) Black or African American | 6 Participants |
| Race (NIH/OMB) More than one race | 1 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants |
| Race (NIH/OMB) White | 18 Participants |
| Region of Enrollment United States | 26 participants |
| Sex: Female, Male Female | 8 Participants |
| Sex: Female, Male Male | 18 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 0 / 24 |
| other Total, other adverse events | 22 / 24 |
| serious Total, serious adverse events | 0 / 24 |
Outcome results
Primary
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.
Time frame: Weeks 8-11 post-quit date (weeks 10-13 post baseline)
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Combination Zonisamide and Bupropion With E-cigarette | Number of Participants That Completely Switched From Combustible Cigarettes to Halo G6 E-Cigarettes | 8 Participants |
Secondary
Change in Rewarding Effects of Smoking Combustible Cigarettes
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.
Time frame: First week compared to after start of study drugs (Weeks 2-13 post baseline)
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Combination Zonisamide and Bupropion With E-cigarette | Change in Rewarding Effects of Smoking Combustible Cigarettes | CEQ Satisfaction Scale | 0 score on a scale | Standard Deviation 1.2 |
| Combination Zonisamide and Bupropion With E-cigarette | Change in Rewarding Effects of Smoking Combustible Cigarettes | CEQ Psych Reward Scale | 0.2 score on a scale | Standard Deviation 1.1 |
Secondary
Point Abstinence From Combustible Cigarettes
Assessed by self-report utilizing an automated SMS messaging system.
Time frame: Six months post switch day (approximately 6 months post baseline)
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Combination Zonisamide and Bupropion With E-cigarette | Point Abstinence From Combustible Cigarettes | 15 Participants |