Trial Outcomes & Findings for Zonisamide/Bupropion Effects on Switching to Electronic Cigarettes (NCT NCT04388319)
NCT ID: NCT04388319
Last Updated: 2022-04-13
Results Overview
Defined as self-report of no cigarette smoking (not even a puff), confirmed by an expired air CO reading of less than 5 ppm.
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
26 participants
Primary outcome timeframe
Weeks 8-11 post-quit date (weeks 10-13 post baseline)
Results posted on
2022-04-13
Participant Flow
Two participants were enrolled into the study but discontinued prior to taken any study drug.
Participant milestones
| Measure |
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.
|
|---|---|
|
Enrolled in Study
STARTED
|
26
|
|
Enrolled in Study
COMPLETED
|
24
|
|
Enrolled in Study
NOT COMPLETED
|
2
|
|
Treatment Period
STARTED
|
24
|
|
Treatment Period
COMPLETED
|
23
|
|
Treatment Period
NOT COMPLETED
|
1
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Two participants were enrolled into the study but discontinued prior to taken any study drug so analysis is based on the 24 participants who started the study drug.
Baseline characteristics by cohort
| Measure |
Combination Zonisamide and Bupropion With E-cigarette
n=26 Participants
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.
|
|---|---|
|
Cigarettes smoked per day (CPD)
|
21.2 Cigs smoked per day
STANDARD_DEVIATION 6.64 • n=24 Participants • Two participants were enrolled into the study but discontinued prior to taken any study drug so analysis is based on the 24 participants who started the study drug.
|
|
Age, Categorical
<=18 years
|
0 Participants
n=26 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
26 Participants
n=26 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=26 Participants
|
|
Age, Continuous
|
45.1 years
STANDARD_DEVIATION 9.75 • n=26 Participants
|
|
Sex: Female, Male
Female
|
8 Participants
n=26 Participants
|
|
Sex: Female, Male
Male
|
18 Participants
n=26 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
1 Participants
n=26 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
25 Participants
n=26 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=26 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=26 Participants
|
|
Race (NIH/OMB)
Asian
|
1 Participants
n=26 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=26 Participants
|
|
Race (NIH/OMB)
Black or African American
|
6 Participants
n=26 Participants
|
|
Race (NIH/OMB)
White
|
18 Participants
n=26 Participants
|
|
Race (NIH/OMB)
More than one race
|
1 Participants
n=26 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=26 Participants
|
|
Region of Enrollment
United States
|
26 participants
n=26 Participants
|
|
FTND -- The Fagerström Test for Nicotine Dependence Score
|
6.1 units on a scale
STANDARD_DEVIATION 1.82 • n=24 Participants • Two participants were enrolled into the study but discontinued prior to taken any study drug so analysis is based on the 24 participants who started the study drug.
|
|
Expired air carbon monoxide (CO)
|
26.0 ppm
STANDARD_DEVIATION 9.19 • n=24 Participants • Two participants were enrolled into the study but discontinued prior to taken any study drug so analysis is based on the 24 participants who started the study drug.
|
PRIMARY outcome
Timeframe: 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.
Outcome measures
| Measure |
Combination Zonisamide and Bupropion With E-cigarette
n=24 Participants
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.
|
|---|---|
|
Number of Participants That Completely Switched From Combustible Cigarettes to Halo G6 E-Cigarettes
|
8 Participants
|
SECONDARY outcome
Timeframe: Six months post switch day (approximately 6 months post baseline)Assessed by self-report utilizing an automated SMS messaging system.
Outcome measures
| Measure |
Combination Zonisamide and Bupropion With E-cigarette
n=24 Participants
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.
|
|---|---|
|
Point Abstinence From Combustible Cigarettes
|
15 Participants
|
SECONDARY outcome
Timeframe: 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.
Outcome measures
| Measure |
Combination Zonisamide and Bupropion With E-cigarette
n=24 Participants
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.
|
|---|---|
|
Change in Rewarding Effects of Smoking Combustible Cigarettes
CEQ Satisfaction Scale
|
0 score on a scale
Standard Deviation 1.2
|
|
Change in Rewarding Effects of Smoking Combustible Cigarettes
CEQ Psych Reward Scale
|
0.2 score on a scale
Standard Deviation 1.1
|
Adverse Events
Combination Zonisamide and Bupropion With E-cigarette
Serious events: 0 serious events
Other events: 22 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Combination Zonisamide and Bupropion With E-cigarette
n=24 participants at risk
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.
|
|---|---|
|
Gastrointestinal disorders
Constipation
|
20.8%
5/24 • Number of events 5 • During 13 week study period.
|
|
Nervous system disorders
Headache
|
20.8%
5/24 • Number of events 5 • During 13 week study period.
|
|
Gastrointestinal disorders
Throat irritation
|
16.7%
4/24 • Number of events 4 • During 13 week study period.
|
|
Gastrointestinal disorders
Nausea
|
16.7%
4/24 • Number of events 4 • During 13 week study period.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
8.3%
2/24 • Number of events 2 • During 13 week study period.
|
|
Nervous system disorders
Tinnitus
|
8.3%
2/24 • Number of events 2 • During 13 week study period.
|
|
Gastrointestinal disorders
Dry mouth
|
8.3%
2/24 • Number of events 2 • During 13 week study period.
|
|
Nervous system disorders
Dizziness
|
8.3%
2/24 • Number of events 2 • During 13 week study period.
|
|
Nervous system disorders
Aversion to cigarettes
|
8.3%
2/24 • Number of events 2 • During 13 week study period.
|
|
Nervous system disorders
Anxiety
|
8.3%
2/24 • Number of events 2 • During 13 week study period.
|
|
Cardiac disorders
Elevated blood pressure
|
8.3%
2/24 • Number of events 3 • During 13 week study period.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place