Trial Outcomes & Findings for Zonisamide Augmentation of Varenicline Treatment for Smoking Cessation (NCT NCT01685996)
NCT ID: NCT01685996
Last Updated: 2018-01-24
Results Overview
Biochemically-verified continuous smoking abstinence during weeks 7-10 of the study.
Recruitment status
COMPLETED
Study phase
PHASE1/PHASE2
Target enrollment
74 participants
Primary outcome timeframe
weeks 7-10
Results posted on
2018-01-24
Participant Flow
Participant milestones
| Measure |
Zonisamide
participants will receive zonisamide capsules (up to 300 mg) to take once a day.
zonisamide: In addition to zonisamide vs placebo treatment, varenicline tablets will be dispensed with specific instructions to take at the recommended doses for smoking cessation Participants will receive brief smoking cessation counseling and referral to a quitline
|
Placebo
Participants will receive placebo capsules to take once a day
placebo
|
|---|---|---|
|
Overall Study
STARTED
|
34
|
40
|
|
Overall Study
COMPLETED
|
18
|
27
|
|
Overall Study
NOT COMPLETED
|
16
|
13
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Zonisamide Augmentation of Varenicline Treatment for Smoking Cessation
Baseline characteristics by cohort
| Measure |
Zonisamide
n=34 Participants
Participants receive zonisamide + varenicline for smoking cessation
|
Placebo
n=40 Participants
Participants receive placebo + varenicline for smoking cessation
|
Total
n=74 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
45.3 years
STANDARD_DEVIATION 9.8 • n=5 Participants
|
45.9 years
STANDARD_DEVIATION 9.7 • n=7 Participants
|
45.6 years
STANDARD_DEVIATION 9.8 • n=5 Participants
|
|
Sex: Female, Male
Female
|
8 Participants
n=5 Participants
|
13 Participants
n=7 Participants
|
21 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
26 Participants
n=5 Participants
|
27 Participants
n=7 Participants
|
53 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
34 Participants
n=5 Participants
|
39 Participants
n=7 Participants
|
73 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
23 Participants
n=5 Participants
|
27 Participants
n=7 Participants
|
50 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
11 Participants
n=5 Participants
|
13 Participants
n=7 Participants
|
24 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
34 participants
n=5 Participants
|
40 participants
n=7 Participants
|
74 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: weeks 7-10Biochemically-verified continuous smoking abstinence during weeks 7-10 of the study.
Outcome measures
| Measure |
Zonisamide
n=34 Participants
participants will receive zonisamide capsules (up to 300 mg) to take once a day.
zonisamide: In addition to zonisamide vs placebo treatment, varenicline tablets will be dispensed with specific instructions to take at the recommended doses for smoking cessation Participants will receive brief smoking cessation counseling and referral to a quitline
|
Placebo
n=40 Participants
Participants will receive placebo capsules to take once a day
placebo
|
|---|---|---|
|
Percent Participants Abstinent From Smoking During Study Weeks 7-10
|
5 Participants
|
6 Participants
|
SECONDARY outcome
Timeframe: Past 24 hoursTotal Score from the Minnesota Nicotine Withdrawal Questionnaire (MNWQ), assessed at weekly visits. The MNWQ is a commonly-used 12-item Likert scale self-report measure of nicotine symptoms. Individual symptoms were rated from 0 (none) to 4 (severe) for each item and the Total score range was 0 - 48. Ratings were collected once weekly during study visits.
Outcome measures
| Measure |
Zonisamide
n=34 Participants
participants will receive zonisamide capsules (up to 300 mg) to take once a day.
zonisamide: In addition to zonisamide vs placebo treatment, varenicline tablets will be dispensed with specific instructions to take at the recommended doses for smoking cessation Participants will receive brief smoking cessation counseling and referral to a quitline
|
Placebo
n=40 Participants
Participants will receive placebo capsules to take once a day
placebo
|
|---|---|---|
|
Nicotine Withdrawal Symptom Severity
Screening Visit
|
4.6 units on a scale
Standard Deviation 6.0
|
5.6 units on a scale
Standard Deviation 5.5
|
|
Nicotine Withdrawal Symptom Severity
Admission Visit
|
5.1 units on a scale
Standard Deviation 5.3
|
7.0 units on a scale
Standard Deviation 6.3
|
|
Nicotine Withdrawal Symptom Severity
Week 1 (pre-quit day)
|
5.3 units on a scale
Standard Deviation 6.
|
6.2 units on a scale
Standard Deviation 7.3
|
|
Nicotine Withdrawal Symptom Severity
Week 2 (pre-quit day)
|
4.8 units on a scale
Standard Deviation 6.0
|
5.7 units on a scale
Standard Deviation 6.3
|
|
Nicotine Withdrawal Symptom Severity
Week 6
|
3.4 units on a scale
Standard Deviation 4.3
|
4.0 units on a scale
Standard Deviation 5.0
|
|
Nicotine Withdrawal Symptom Severity
Week 7
|
3.8 units on a scale
Standard Deviation 4.7
|
4.4 units on a scale
Standard Deviation 4.7
|
|
Nicotine Withdrawal Symptom Severity
Week 8
|
2.7 units on a scale
Standard Deviation 3.3
|
4.0 units on a scale
Standard Deviation 4.5
|
|
Nicotine Withdrawal Symptom Severity
Week 9
|
3.1 units on a scale
Standard Deviation 3.0
|
4.1 units on a scale
Standard Deviation 4.4
|
|
Nicotine Withdrawal Symptom Severity
Week 10
|
2.6 units on a scale
Standard Deviation 4.9
|
4.8 units on a scale
Standard Deviation 5.8
|
|
Nicotine Withdrawal Symptom Severity
Week 3 (target quit day)
|
4.7 units on a scale
Standard Deviation 5.4
|
6.6 units on a scale
Standard Deviation 7.0
|
|
Nicotine Withdrawal Symptom Severity
Week 4
|
3.8 units on a scale
Standard Deviation 5.1
|
5.9 units on a scale
Standard Deviation 7.0
|
|
Nicotine Withdrawal Symptom Severity
Week 5
|
3.8 units on a scale
Standard Deviation 3.7
|
4.7 units on a scale
Standard Deviation 5.3
|
Adverse Events
Zonisamide
Serious events: 0 serious events
Other events: 28 other events
Deaths: 0 deaths
Placebo
Serious events: 0 serious events
Other events: 28 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Zonisamide
n=34 participants at risk
participants will receive zonisamide capsules (up to 300 mg) to take once a day.
zonisamide: In addition to zonisamide vs placebo treatment, varenicline tablets will be dispensed with specific instructions to take at the recommended doses for smoking cessation Participants will receive brief smoking cessation counseling and referral to a quitline
|
Placebo
n=40 participants at risk
Participants will receive placebo capsules to take once a day
placebo
|
|---|---|---|
|
Cardiac disorders
Chest Pain
|
5.9%
2/34 • Number of events 2 • Adverse events were collected systematically during each study visit for the duration of the 10-week study. All events that were rated as being possibly, probably, or definitely related to study participation are reported. Events can represent nicotine withdrawal symptoms (e.g. all events were documented and nicotine withdrawal symptoms were not excluded from Adverse Events (AE) reporting).
|
0.00%
0/40 • Adverse events were collected systematically during each study visit for the duration of the 10-week study. All events that were rated as being possibly, probably, or definitely related to study participation are reported. Events can represent nicotine withdrawal symptoms (e.g. all events were documented and nicotine withdrawal symptoms were not excluded from Adverse Events (AE) reporting).
|
|
General disorders
Chills
|
2.9%
1/34 • Number of events 1 • Adverse events were collected systematically during each study visit for the duration of the 10-week study. All events that were rated as being possibly, probably, or definitely related to study participation are reported. Events can represent nicotine withdrawal symptoms (e.g. all events were documented and nicotine withdrawal symptoms were not excluded from Adverse Events (AE) reporting).
|
0.00%
0/40 • Adverse events were collected systematically during each study visit for the duration of the 10-week study. All events that were rated as being possibly, probably, or definitely related to study participation are reported. Events can represent nicotine withdrawal symptoms (e.g. all events were documented and nicotine withdrawal symptoms were not excluded from Adverse Events (AE) reporting).
|
|
General disorders
Headache
|
14.7%
5/34 • Number of events 5 • Adverse events were collected systematically during each study visit for the duration of the 10-week study. All events that were rated as being possibly, probably, or definitely related to study participation are reported. Events can represent nicotine withdrawal symptoms (e.g. all events were documented and nicotine withdrawal symptoms were not excluded from Adverse Events (AE) reporting).
|
10.0%
4/40 • Number of events 6 • Adverse events were collected systematically during each study visit for the duration of the 10-week study. All events that were rated as being possibly, probably, or definitely related to study participation are reported. Events can represent nicotine withdrawal symptoms (e.g. all events were documented and nicotine withdrawal symptoms were not excluded from Adverse Events (AE) reporting).
|
|
Skin and subcutaneous tissue disorders
Skin Rash
|
2.9%
1/34 • Number of events 1 • Adverse events were collected systematically during each study visit for the duration of the 10-week study. All events that were rated as being possibly, probably, or definitely related to study participation are reported. Events can represent nicotine withdrawal symptoms (e.g. all events were documented and nicotine withdrawal symptoms were not excluded from Adverse Events (AE) reporting).
|
0.00%
0/40 • Adverse events were collected systematically during each study visit for the duration of the 10-week study. All events that were rated as being possibly, probably, or definitely related to study participation are reported. Events can represent nicotine withdrawal symptoms (e.g. all events were documented and nicotine withdrawal symptoms were not excluded from Adverse Events (AE) reporting).
|
|
Skin and subcutaneous tissue disorders
Pruritis (itching)
|
2.9%
1/34 • Number of events 1 • Adverse events were collected systematically during each study visit for the duration of the 10-week study. All events that were rated as being possibly, probably, or definitely related to study participation are reported. Events can represent nicotine withdrawal symptoms (e.g. all events were documented and nicotine withdrawal symptoms were not excluded from Adverse Events (AE) reporting).
|
0.00%
0/40 • Adverse events were collected systematically during each study visit for the duration of the 10-week study. All events that were rated as being possibly, probably, or definitely related to study participation are reported. Events can represent nicotine withdrawal symptoms (e.g. all events were documented and nicotine withdrawal symptoms were not excluded from Adverse Events (AE) reporting).
|
|
Skin and subcutaneous tissue disorders
Sweating Increased
|
8.8%
3/34 • Number of events 3 • Adverse events were collected systematically during each study visit for the duration of the 10-week study. All events that were rated as being possibly, probably, or definitely related to study participation are reported. Events can represent nicotine withdrawal symptoms (e.g. all events were documented and nicotine withdrawal symptoms were not excluded from Adverse Events (AE) reporting).
|
0.00%
0/40 • Adverse events were collected systematically during each study visit for the duration of the 10-week study. All events that were rated as being possibly, probably, or definitely related to study participation are reported. Events can represent nicotine withdrawal symptoms (e.g. all events were documented and nicotine withdrawal symptoms were not excluded from Adverse Events (AE) reporting).
|
|
Gastrointestinal disorders
Abdominal Pain
|
2.9%
1/34 • Number of events 1 • Adverse events were collected systematically during each study visit for the duration of the 10-week study. All events that were rated as being possibly, probably, or definitely related to study participation are reported. Events can represent nicotine withdrawal symptoms (e.g. all events were documented and nicotine withdrawal symptoms were not excluded from Adverse Events (AE) reporting).
|
2.5%
1/40 • Number of events 1 • Adverse events were collected systematically during each study visit for the duration of the 10-week study. All events that were rated as being possibly, probably, or definitely related to study participation are reported. Events can represent nicotine withdrawal symptoms (e.g. all events were documented and nicotine withdrawal symptoms were not excluded from Adverse Events (AE) reporting).
|
|
Gastrointestinal disorders
Constipation
|
14.7%
5/34 • Number of events 6 • Adverse events were collected systematically during each study visit for the duration of the 10-week study. All events that were rated as being possibly, probably, or definitely related to study participation are reported. Events can represent nicotine withdrawal symptoms (e.g. all events were documented and nicotine withdrawal symptoms were not excluded from Adverse Events (AE) reporting).
|
10.0%
4/40 • Number of events 4 • Adverse events were collected systematically during each study visit for the duration of the 10-week study. All events that were rated as being possibly, probably, or definitely related to study participation are reported. Events can represent nicotine withdrawal symptoms (e.g. all events were documented and nicotine withdrawal symptoms were not excluded from Adverse Events (AE) reporting).
|
|
Gastrointestinal disorders
Diarrhea
|
5.9%
2/34 • Number of events 2 • Adverse events were collected systematically during each study visit for the duration of the 10-week study. All events that were rated as being possibly, probably, or definitely related to study participation are reported. Events can represent nicotine withdrawal symptoms (e.g. all events were documented and nicotine withdrawal symptoms were not excluded from Adverse Events (AE) reporting).
|
2.5%
1/40 • Number of events 1 • Adverse events were collected systematically during each study visit for the duration of the 10-week study. All events that were rated as being possibly, probably, or definitely related to study participation are reported. Events can represent nicotine withdrawal symptoms (e.g. all events were documented and nicotine withdrawal symptoms were not excluded from Adverse Events (AE) reporting).
|
|
Gastrointestinal disorders
Dry Mouth
|
2.9%
1/34 • Number of events 1 • Adverse events were collected systematically during each study visit for the duration of the 10-week study. All events that were rated as being possibly, probably, or definitely related to study participation are reported. Events can represent nicotine withdrawal symptoms (e.g. all events were documented and nicotine withdrawal symptoms were not excluded from Adverse Events (AE) reporting).
|
0.00%
0/40 • Adverse events were collected systematically during each study visit for the duration of the 10-week study. All events that were rated as being possibly, probably, or definitely related to study participation are reported. Events can represent nicotine withdrawal symptoms (e.g. all events were documented and nicotine withdrawal symptoms were not excluded from Adverse Events (AE) reporting).
|
|
Gastrointestinal disorders
Dyspepsia
|
2.9%
1/34 • Number of events 1 • Adverse events were collected systematically during each study visit for the duration of the 10-week study. All events that were rated as being possibly, probably, or definitely related to study participation are reported. Events can represent nicotine withdrawal symptoms (e.g. all events were documented and nicotine withdrawal symptoms were not excluded from Adverse Events (AE) reporting).
|
0.00%
0/40 • Adverse events were collected systematically during each study visit for the duration of the 10-week study. All events that were rated as being possibly, probably, or definitely related to study participation are reported. Events can represent nicotine withdrawal symptoms (e.g. all events were documented and nicotine withdrawal symptoms were not excluded from Adverse Events (AE) reporting).
|
|
Gastrointestinal disorders
Nausea
|
32.4%
11/34 • Number of events 14 • Adverse events were collected systematically during each study visit for the duration of the 10-week study. All events that were rated as being possibly, probably, or definitely related to study participation are reported. Events can represent nicotine withdrawal symptoms (e.g. all events were documented and nicotine withdrawal symptoms were not excluded from Adverse Events (AE) reporting).
|
27.5%
11/40 • Number of events 14 • Adverse events were collected systematically during each study visit for the duration of the 10-week study. All events that were rated as being possibly, probably, or definitely related to study participation are reported. Events can represent nicotine withdrawal symptoms (e.g. all events were documented and nicotine withdrawal symptoms were not excluded from Adverse Events (AE) reporting).
|
|
Gastrointestinal disorders
Sore Throat
|
2.9%
1/34 • Number of events 1 • Adverse events were collected systematically during each study visit for the duration of the 10-week study. All events that were rated as being possibly, probably, or definitely related to study participation are reported. Events can represent nicotine withdrawal symptoms (e.g. all events were documented and nicotine withdrawal symptoms were not excluded from Adverse Events (AE) reporting).
|
0.00%
0/40 • Adverse events were collected systematically during each study visit for the duration of the 10-week study. All events that were rated as being possibly, probably, or definitely related to study participation are reported. Events can represent nicotine withdrawal symptoms (e.g. all events were documented and nicotine withdrawal symptoms were not excluded from Adverse Events (AE) reporting).
|
|
Gastrointestinal disorders
Vomiting
|
11.8%
4/34 • Number of events 4 • Adverse events were collected systematically during each study visit for the duration of the 10-week study. All events that were rated as being possibly, probably, or definitely related to study participation are reported. Events can represent nicotine withdrawal symptoms (e.g. all events were documented and nicotine withdrawal symptoms were not excluded from Adverse Events (AE) reporting).
|
5.0%
2/40 • Number of events 2 • Adverse events were collected systematically during each study visit for the duration of the 10-week study. All events that were rated as being possibly, probably, or definitely related to study participation are reported. Events can represent nicotine withdrawal symptoms (e.g. all events were documented and nicotine withdrawal symptoms were not excluded from Adverse Events (AE) reporting).
|
|
Hepatobiliary disorders
Chemistry Abnormal
|
5.9%
2/34 • Number of events 2 • Adverse events were collected systematically during each study visit for the duration of the 10-week study. All events that were rated as being possibly, probably, or definitely related to study participation are reported. Events can represent nicotine withdrawal symptoms (e.g. all events were documented and nicotine withdrawal symptoms were not excluded from Adverse Events (AE) reporting).
|
7.5%
3/40 • Number of events 3 • Adverse events were collected systematically during each study visit for the duration of the 10-week study. All events that were rated as being possibly, probably, or definitely related to study participation are reported. Events can represent nicotine withdrawal symptoms (e.g. all events were documented and nicotine withdrawal symptoms were not excluded from Adverse Events (AE) reporting).
|
|
Metabolism and nutrition disorders
Dehydration
|
0.00%
0/34 • Adverse events were collected systematically during each study visit for the duration of the 10-week study. All events that were rated as being possibly, probably, or definitely related to study participation are reported. Events can represent nicotine withdrawal symptoms (e.g. all events were documented and nicotine withdrawal symptoms were not excluded from Adverse Events (AE) reporting).
|
2.5%
1/40 • Number of events 1 • Adverse events were collected systematically during each study visit for the duration of the 10-week study. All events that were rated as being possibly, probably, or definitely related to study participation are reported. Events can represent nicotine withdrawal symptoms (e.g. all events were documented and nicotine withdrawal symptoms were not excluded from Adverse Events (AE) reporting).
|
|
Musculoskeletal and connective tissue disorders
Back Pain
|
0.00%
0/34 • Adverse events were collected systematically during each study visit for the duration of the 10-week study. All events that were rated as being possibly, probably, or definitely related to study participation are reported. Events can represent nicotine withdrawal symptoms (e.g. all events were documented and nicotine withdrawal symptoms were not excluded from Adverse Events (AE) reporting).
|
2.5%
1/40 • Number of events 1 • Adverse events were collected systematically during each study visit for the duration of the 10-week study. All events that were rated as being possibly, probably, or definitely related to study participation are reported. Events can represent nicotine withdrawal symptoms (e.g. all events were documented and nicotine withdrawal symptoms were not excluded from Adverse Events (AE) reporting).
|
|
Musculoskeletal and connective tissue disorders
Jaw Pain
|
0.00%
0/34 • Adverse events were collected systematically during each study visit for the duration of the 10-week study. All events that were rated as being possibly, probably, or definitely related to study participation are reported. Events can represent nicotine withdrawal symptoms (e.g. all events were documented and nicotine withdrawal symptoms were not excluded from Adverse Events (AE) reporting).
|
2.5%
1/40 • Number of events 1 • Adverse events were collected systematically during each study visit for the duration of the 10-week study. All events that were rated as being possibly, probably, or definitely related to study participation are reported. Events can represent nicotine withdrawal symptoms (e.g. all events were documented and nicotine withdrawal symptoms were not excluded from Adverse Events (AE) reporting).
|
|
Musculoskeletal and connective tissue disorders
Pain Lower Extremity
|
0.00%
0/34 • Adverse events were collected systematically during each study visit for the duration of the 10-week study. All events that were rated as being possibly, probably, or definitely related to study participation are reported. Events can represent nicotine withdrawal symptoms (e.g. all events were documented and nicotine withdrawal symptoms were not excluded from Adverse Events (AE) reporting).
|
2.5%
1/40 • Number of events 1 • Adverse events were collected systematically during each study visit for the duration of the 10-week study. All events that were rated as being possibly, probably, or definitely related to study participation are reported. Events can represent nicotine withdrawal symptoms (e.g. all events were documented and nicotine withdrawal symptoms were not excluded from Adverse Events (AE) reporting).
|
|
Nervous system disorders
Adjustment Disorder
|
2.9%
1/34 • Number of events 1 • Adverse events were collected systematically during each study visit for the duration of the 10-week study. All events that were rated as being possibly, probably, or definitely related to study participation are reported. Events can represent nicotine withdrawal symptoms (e.g. all events were documented and nicotine withdrawal symptoms were not excluded from Adverse Events (AE) reporting).
|
0.00%
0/40 • Adverse events were collected systematically during each study visit for the duration of the 10-week study. All events that were rated as being possibly, probably, or definitely related to study participation are reported. Events can represent nicotine withdrawal symptoms (e.g. all events were documented and nicotine withdrawal symptoms were not excluded from Adverse Events (AE) reporting).
|
|
Nervous system disorders
Ataxia
|
2.9%
1/34 • Number of events 1 • Adverse events were collected systematically during each study visit for the duration of the 10-week study. All events that were rated as being possibly, probably, or definitely related to study participation are reported. Events can represent nicotine withdrawal symptoms (e.g. all events were documented and nicotine withdrawal symptoms were not excluded from Adverse Events (AE) reporting).
|
0.00%
0/40 • Adverse events were collected systematically during each study visit for the duration of the 10-week study. All events that were rated as being possibly, probably, or definitely related to study participation are reported. Events can represent nicotine withdrawal symptoms (e.g. all events were documented and nicotine withdrawal symptoms were not excluded from Adverse Events (AE) reporting).
|
|
Psychiatric disorders
Change in Mental Status
|
0.00%
0/34 • Adverse events were collected systematically during each study visit for the duration of the 10-week study. All events that were rated as being possibly, probably, or definitely related to study participation are reported. Events can represent nicotine withdrawal symptoms (e.g. all events were documented and nicotine withdrawal symptoms were not excluded from Adverse Events (AE) reporting).
|
2.5%
1/40 • Number of events 1 • Adverse events were collected systematically during each study visit for the duration of the 10-week study. All events that were rated as being possibly, probably, or definitely related to study participation are reported. Events can represent nicotine withdrawal symptoms (e.g. all events were documented and nicotine withdrawal symptoms were not excluded from Adverse Events (AE) reporting).
|
|
Nervous system disorders
Difficulty Concentrating
|
2.9%
1/34 • Number of events 1 • Adverse events were collected systematically during each study visit for the duration of the 10-week study. All events that were rated as being possibly, probably, or definitely related to study participation are reported. Events can represent nicotine withdrawal symptoms (e.g. all events were documented and nicotine withdrawal symptoms were not excluded from Adverse Events (AE) reporting).
|
0.00%
0/40 • Adverse events were collected systematically during each study visit for the duration of the 10-week study. All events that were rated as being possibly, probably, or definitely related to study participation are reported. Events can represent nicotine withdrawal symptoms (e.g. all events were documented and nicotine withdrawal symptoms were not excluded from Adverse Events (AE) reporting).
|
|
Nervous system disorders
Agitation
|
8.8%
3/34 • Number of events 3 • Adverse events were collected systematically during each study visit for the duration of the 10-week study. All events that were rated as being possibly, probably, or definitely related to study participation are reported. Events can represent nicotine withdrawal symptoms (e.g. all events were documented and nicotine withdrawal symptoms were not excluded from Adverse Events (AE) reporting).
|
2.5%
1/40 • Number of events 1 • Adverse events were collected systematically during each study visit for the duration of the 10-week study. All events that were rated as being possibly, probably, or definitely related to study participation are reported. Events can represent nicotine withdrawal symptoms (e.g. all events were documented and nicotine withdrawal symptoms were not excluded from Adverse Events (AE) reporting).
|
|
Nervous system disorders
Anxiety
|
0.00%
0/34 • Adverse events were collected systematically during each study visit for the duration of the 10-week study. All events that were rated as being possibly, probably, or definitely related to study participation are reported. Events can represent nicotine withdrawal symptoms (e.g. all events were documented and nicotine withdrawal symptoms were not excluded from Adverse Events (AE) reporting).
|
7.5%
3/40 • Number of events 3 • Adverse events were collected systematically during each study visit for the duration of the 10-week study. All events that were rated as being possibly, probably, or definitely related to study participation are reported. Events can represent nicotine withdrawal symptoms (e.g. all events were documented and nicotine withdrawal symptoms were not excluded from Adverse Events (AE) reporting).
|
|
Nervous system disorders
Depression
|
2.9%
1/34 • Number of events 1 • Adverse events were collected systematically during each study visit for the duration of the 10-week study. All events that were rated as being possibly, probably, or definitely related to study participation are reported. Events can represent nicotine withdrawal symptoms (e.g. all events were documented and nicotine withdrawal symptoms were not excluded from Adverse Events (AE) reporting).
|
5.0%
2/40 • Number of events 2 • Adverse events were collected systematically during each study visit for the duration of the 10-week study. All events that were rated as being possibly, probably, or definitely related to study participation are reported. Events can represent nicotine withdrawal symptoms (e.g. all events were documented and nicotine withdrawal symptoms were not excluded from Adverse Events (AE) reporting).
|
|
Nervous system disorders
Dizziness
|
8.8%
3/34 • Number of events 3 • Adverse events were collected systematically during each study visit for the duration of the 10-week study. All events that were rated as being possibly, probably, or definitely related to study participation are reported. Events can represent nicotine withdrawal symptoms (e.g. all events were documented and nicotine withdrawal symptoms were not excluded from Adverse Events (AE) reporting).
|
5.0%
2/40 • Number of events 2 • Adverse events were collected systematically during each study visit for the duration of the 10-week study. All events that were rated as being possibly, probably, or definitely related to study participation are reported. Events can represent nicotine withdrawal symptoms (e.g. all events were documented and nicotine withdrawal symptoms were not excluded from Adverse Events (AE) reporting).
|
|
Nervous system disorders
Dream Abnormal
|
23.5%
8/34 • Number of events 9 • Adverse events were collected systematically during each study visit for the duration of the 10-week study. All events that were rated as being possibly, probably, or definitely related to study participation are reported. Events can represent nicotine withdrawal symptoms (e.g. all events were documented and nicotine withdrawal symptoms were not excluded from Adverse Events (AE) reporting).
|
17.5%
7/40 • Number of events 7 • Adverse events were collected systematically during each study visit for the duration of the 10-week study. All events that were rated as being possibly, probably, or definitely related to study participation are reported. Events can represent nicotine withdrawal symptoms (e.g. all events were documented and nicotine withdrawal symptoms were not excluded from Adverse Events (AE) reporting).
|
|
Nervous system disorders
Drowsiness
|
17.6%
6/34 • Number of events 6 • Adverse events were collected systematically during each study visit for the duration of the 10-week study. All events that were rated as being possibly, probably, or definitely related to study participation are reported. Events can represent nicotine withdrawal symptoms (e.g. all events were documented and nicotine withdrawal symptoms were not excluded from Adverse Events (AE) reporting).
|
10.0%
4/40 • Number of events 5 • Adverse events were collected systematically during each study visit for the duration of the 10-week study. All events that were rated as being possibly, probably, or definitely related to study participation are reported. Events can represent nicotine withdrawal symptoms (e.g. all events were documented and nicotine withdrawal symptoms were not excluded from Adverse Events (AE) reporting).
|
|
Nervous system disorders
Fatigue
|
5.9%
2/34 • Number of events 2 • Adverse events were collected systematically during each study visit for the duration of the 10-week study. All events that were rated as being possibly, probably, or definitely related to study participation are reported. Events can represent nicotine withdrawal symptoms (e.g. all events were documented and nicotine withdrawal symptoms were not excluded from Adverse Events (AE) reporting).
|
0.00%
0/40 • Adverse events were collected systematically during each study visit for the duration of the 10-week study. All events that were rated as being possibly, probably, or definitely related to study participation are reported. Events can represent nicotine withdrawal symptoms (e.g. all events were documented and nicotine withdrawal symptoms were not excluded from Adverse Events (AE) reporting).
|
|
Nervous system disorders
Insomnia
|
20.6%
7/34 • Number of events 8 • Adverse events were collected systematically during each study visit for the duration of the 10-week study. All events that were rated as being possibly, probably, or definitely related to study participation are reported. Events can represent nicotine withdrawal symptoms (e.g. all events were documented and nicotine withdrawal symptoms were not excluded from Adverse Events (AE) reporting).
|
7.5%
3/40 • Number of events 3 • Adverse events were collected systematically during each study visit for the duration of the 10-week study. All events that were rated as being possibly, probably, or definitely related to study participation are reported. Events can represent nicotine withdrawal symptoms (e.g. all events were documented and nicotine withdrawal symptoms were not excluded from Adverse Events (AE) reporting).
|
|
Nervous system disorders
Irritability
|
17.6%
6/34 • Number of events 6 • Adverse events were collected systematically during each study visit for the duration of the 10-week study. All events that were rated as being possibly, probably, or definitely related to study participation are reported. Events can represent nicotine withdrawal symptoms (e.g. all events were documented and nicotine withdrawal symptoms were not excluded from Adverse Events (AE) reporting).
|
17.5%
7/40 • Number of events 7 • Adverse events were collected systematically during each study visit for the duration of the 10-week study. All events that were rated as being possibly, probably, or definitely related to study participation are reported. Events can represent nicotine withdrawal symptoms (e.g. all events were documented and nicotine withdrawal symptoms were not excluded from Adverse Events (AE) reporting).
|
|
Nervous system disorders
Paranoid
|
2.9%
1/34 • Number of events 1 • Adverse events were collected systematically during each study visit for the duration of the 10-week study. All events that were rated as being possibly, probably, or definitely related to study participation are reported. Events can represent nicotine withdrawal symptoms (e.g. all events were documented and nicotine withdrawal symptoms were not excluded from Adverse Events (AE) reporting).
|
0.00%
0/40 • Adverse events were collected systematically during each study visit for the duration of the 10-week study. All events that were rated as being possibly, probably, or definitely related to study participation are reported. Events can represent nicotine withdrawal symptoms (e.g. all events were documented and nicotine withdrawal symptoms were not excluded from Adverse Events (AE) reporting).
|
|
Nervous system disorders
Paresthesia
|
2.9%
1/34 • Number of events 1 • Adverse events were collected systematically during each study visit for the duration of the 10-week study. All events that were rated as being possibly, probably, or definitely related to study participation are reported. Events can represent nicotine withdrawal symptoms (e.g. all events were documented and nicotine withdrawal symptoms were not excluded from Adverse Events (AE) reporting).
|
0.00%
0/40 • Adverse events were collected systematically during each study visit for the duration of the 10-week study. All events that were rated as being possibly, probably, or definitely related to study participation are reported. Events can represent nicotine withdrawal symptoms (e.g. all events were documented and nicotine withdrawal symptoms were not excluded from Adverse Events (AE) reporting).
|
|
Nervous system disorders
Restlessness
|
2.9%
1/34 • Number of events 1 • Adverse events were collected systematically during each study visit for the duration of the 10-week study. All events that were rated as being possibly, probably, or definitely related to study participation are reported. Events can represent nicotine withdrawal symptoms (e.g. all events were documented and nicotine withdrawal symptoms were not excluded from Adverse Events (AE) reporting).
|
0.00%
0/40 • Adverse events were collected systematically during each study visit for the duration of the 10-week study. All events that were rated as being possibly, probably, or definitely related to study participation are reported. Events can represent nicotine withdrawal symptoms (e.g. all events were documented and nicotine withdrawal symptoms were not excluded from Adverse Events (AE) reporting).
|
|
Respiratory, thoracic and mediastinal disorders
Sinusitis
|
0.00%
0/34 • Adverse events were collected systematically during each study visit for the duration of the 10-week study. All events that were rated as being possibly, probably, or definitely related to study participation are reported. Events can represent nicotine withdrawal symptoms (e.g. all events were documented and nicotine withdrawal symptoms were not excluded from Adverse Events (AE) reporting).
|
2.5%
1/40 • Number of events 1 • Adverse events were collected systematically during each study visit for the duration of the 10-week study. All events that were rated as being possibly, probably, or definitely related to study participation are reported. Events can represent nicotine withdrawal symptoms (e.g. all events were documented and nicotine withdrawal symptoms were not excluded from Adverse Events (AE) reporting).
|
|
Skin and subcutaneous tissue disorders
Hot Flashes
|
2.9%
1/34 • Number of events 1 • Adverse events were collected systematically during each study visit for the duration of the 10-week study. All events that were rated as being possibly, probably, or definitely related to study participation are reported. Events can represent nicotine withdrawal symptoms (e.g. all events were documented and nicotine withdrawal symptoms were not excluded from Adverse Events (AE) reporting).
|
0.00%
0/40 • Adverse events were collected systematically during each study visit for the duration of the 10-week study. All events that were rated as being possibly, probably, or definitely related to study participation are reported. Events can represent nicotine withdrawal symptoms (e.g. all events were documented and nicotine withdrawal symptoms were not excluded from Adverse Events (AE) reporting).
|
|
Skin and subcutaneous tissue disorders
Itching Eyes
|
2.9%
1/34 • Number of events 1 • Adverse events were collected systematically during each study visit for the duration of the 10-week study. All events that were rated as being possibly, probably, or definitely related to study participation are reported. Events can represent nicotine withdrawal symptoms (e.g. all events were documented and nicotine withdrawal symptoms were not excluded from Adverse Events (AE) reporting).
|
0.00%
0/40 • Adverse events were collected systematically during each study visit for the duration of the 10-week study. All events that were rated as being possibly, probably, or definitely related to study participation are reported. Events can represent nicotine withdrawal symptoms (e.g. all events were documented and nicotine withdrawal symptoms were not excluded from Adverse Events (AE) reporting).
|
|
Skin and subcutaneous tissue disorders
Pain- Eye
|
2.9%
1/34 • Number of events 1 • Adverse events were collected systematically during each study visit for the duration of the 10-week study. All events that were rated as being possibly, probably, or definitely related to study participation are reported. Events can represent nicotine withdrawal symptoms (e.g. all events were documented and nicotine withdrawal symptoms were not excluded from Adverse Events (AE) reporting).
|
0.00%
0/40 • Adverse events were collected systematically during each study visit for the duration of the 10-week study. All events that were rated as being possibly, probably, or definitely related to study participation are reported. Events can represent nicotine withdrawal symptoms (e.g. all events were documented and nicotine withdrawal symptoms were not excluded from Adverse Events (AE) reporting).
|
Additional Information
Dr. Annie Umbricht, M.D.
Johns Hopkins University School of Medicine
Phone: 410-550-1917
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place