Trial Outcomes & Findings for Meclizine as a Potential Smoking Cessation Treatment (NCT NCT01443858)
NCT ID: NCT01443858
Last Updated: 2014-08-01
Results Overview
To evaluate the effects of meclizine alone on ad lib smoking, the percent decrease in expired air carbon monoxide (CO) at the end of week 1 (relative to baseline) will be compared (using ANOVA) between each meclizine group and placebo.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
146 participants
Primary outcome timeframe
After 1 week of treatment (relative to baseline)
Results posted on
2014-08-01
Participant Flow
Recruitment began on 9/16/11 and ended on 11/30/12. Of the 146 subjects consented during this period, 72 were in our Charlotte, NC office, 45 were in our Durham, NC office and 29 were in our Raleigh, NC office. Of the 146 subjects consented during this study only 75 subjects met all study criteria and were assigned to a study arm.
Participant milestones
| Measure |
Control
Subjects in this group will take placebo meclizine daily for the three weeks prior to their quit date. Subjects will also apply a 21mg/24h nicotine patch daily starting in the second week of pre-quit treatment. Placebo meclizine will be administered in two doses each day.
Nicotine patches: Pre-Quit Period: During weeks two and three, participants will apply active 21mg/24h nicotine patches daily.
Post-Quit Period: Following the quit-day these participants will apply active nicotine patches daily using the following dose schedule: 21mg/24h for four weeks, 14mg/24h for one week, and 7mg/24h for one week.
|
25mg Meclizine
Subjects in this group will take 25mg of meclizine daily for the three weeks prior to their quit date. Subjects will also apply a 21mg/24h nicotine patch daily starting in the second week of pre-quit treatment. Meclizine will be administered in two doses each day.
Meclizine: Pre-Quit Period: In this group, participants will take meclizine daily during the three week pre-quit period. The meclizine will be taken in two doses daily, one capsule with breakfast and one with dinner.
Nicotine patches: Pre-Quit Period: During weeks two and three, participants will apply active 21mg/24h nicotine patches daily.
Post-Quit Period: Following the quit-day these participants will apply active nicotine patches daily using the following dose schedule: 21mg/24h for four weeks, 14mg/24h for one week, and 7mg/24h for one week.
|
50mg Meclizine
Subjects in this group will take 50mg of meclizine daily for the three weeks prior to their quit date. Subjects will also apply a 21mg/24h nicotine patch daily starting in the second week of pre-quit treatment. Meclizine will be administered in two doses each day.
Meclizine: Pre-Quit Period: In this group, participants will take meclizine daily during the three week pre-quit period. The meclizine will be taken in two doses daily, one capsule with breakfast and one with dinner.
Nicotine patches: Pre-Quit Period: During weeks two and three, participants will apply active 21mg/24h nicotine patches daily.
Post-Quit Period: Following the quit-day these participants will apply active nicotine patches daily using the following dose schedule: 21mg/24h for four weeks, 14mg/24h for one week, and 7mg/24h for one week.
|
|---|---|---|---|
|
Overall Study
STARTED
|
25
|
25
|
25
|
|
Overall Study
COMPLETED
|
10
|
12
|
18
|
|
Overall Study
NOT COMPLETED
|
15
|
13
|
7
|
Reasons for withdrawal
| Measure |
Control
Subjects in this group will take placebo meclizine daily for the three weeks prior to their quit date. Subjects will also apply a 21mg/24h nicotine patch daily starting in the second week of pre-quit treatment. Placebo meclizine will be administered in two doses each day.
Nicotine patches: Pre-Quit Period: During weeks two and three, participants will apply active 21mg/24h nicotine patches daily.
Post-Quit Period: Following the quit-day these participants will apply active nicotine patches daily using the following dose schedule: 21mg/24h for four weeks, 14mg/24h for one week, and 7mg/24h for one week.
|
25mg Meclizine
Subjects in this group will take 25mg of meclizine daily for the three weeks prior to their quit date. Subjects will also apply a 21mg/24h nicotine patch daily starting in the second week of pre-quit treatment. Meclizine will be administered in two doses each day.
Meclizine: Pre-Quit Period: In this group, participants will take meclizine daily during the three week pre-quit period. The meclizine will be taken in two doses daily, one capsule with breakfast and one with dinner.
Nicotine patches: Pre-Quit Period: During weeks two and three, participants will apply active 21mg/24h nicotine patches daily.
Post-Quit Period: Following the quit-day these participants will apply active nicotine patches daily using the following dose schedule: 21mg/24h for four weeks, 14mg/24h for one week, and 7mg/24h for one week.
|
50mg Meclizine
Subjects in this group will take 50mg of meclizine daily for the three weeks prior to their quit date. Subjects will also apply a 21mg/24h nicotine patch daily starting in the second week of pre-quit treatment. Meclizine will be administered in two doses each day.
Meclizine: Pre-Quit Period: In this group, participants will take meclizine daily during the three week pre-quit period. The meclizine will be taken in two doses daily, one capsule with breakfast and one with dinner.
Nicotine patches: Pre-Quit Period: During weeks two and three, participants will apply active 21mg/24h nicotine patches daily.
Post-Quit Period: Following the quit-day these participants will apply active nicotine patches daily using the following dose schedule: 21mg/24h for four weeks, 14mg/24h for one week, and 7mg/24h for one week.
|
|---|---|---|---|
|
Overall Study
Withdrawal by Subject
|
9
|
8
|
5
|
|
Overall Study
Lack of Efficacy
|
1
|
0
|
0
|
|
Overall Study
Lost to Follow-up
|
5
|
5
|
2
|
Baseline Characteristics
Meclizine as a Potential Smoking Cessation Treatment
Baseline characteristics by cohort
| Measure |
Control
n=25 Participants
Subjects in this group will take placebo meclizine daily for the three weeks prior to their quit date. Subjects will also apply a 21mg/24h nicotine patch daily starting in the second week of pre-quit treatment. Placebo meclizine will be administered in two doses each day.
Nicotine patches: Pre-Quit Period: During weeks two and three, participants will apply active 21mg/24h nicotine patches daily.
Post-Quit Period: Following the quit-day these participants will apply active nicotine patches daily using the following dose schedule: 21mg/24h for four weeks, 14mg/24h for one week, and 7mg/24h for one week.
|
25mg Meclizine
n=25 Participants
Subjects in this group will take 25mg of meclizine daily for the three weeks prior to their quit date. Subjects will also apply a 21mg/24h nicotine patch daily starting in the second week of pre-quit treatment. Meclizine will be administered in two doses each day.
Meclizine: Pre-Quit Period: In this group, participants will take meclizine daily during the three week pre-quit period. The meclizine will be taken in two doses daily, one capsule with breakfast and one with dinner.
Nicotine patches: Pre-Quit Period: During weeks two and three, participants will apply active 21mg/24h nicotine patches daily.
Post-Quit Period: Following the quit-day these participants will apply active nicotine patches daily using the following dose schedule: 21mg/24h for four weeks, 14mg/24h for one week, and 7mg/24h for one week.
|
50mg Meclizine
n=25 Participants
Subjects in this group will take 50mg of meclizine daily for the three weeks prior to their quit date. Subjects will also apply a 21mg/24h nicotine patch daily starting in the second week of pre-quit treatment. Meclizine will be administered in two doses each day.
Meclizine: Pre-Quit Period: In this group, participants will take meclizine daily during the three week pre-quit period. The meclizine will be taken in two doses daily, one capsule with breakfast and one with dinner.
Nicotine patches: Pre-Quit Period: During weeks two and three, participants will apply active 21mg/24h nicotine patches daily.
Post-Quit Period: Following the quit-day these participants will apply active nicotine patches daily using the following dose schedule: 21mg/24h for four weeks, 14mg/24h for one week, and 7mg/24h for one week.
|
Total
n=75 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Continuous
|
42.80 years
STANDARD_DEVIATION 12.3 • n=5 Participants
|
42.40 years
STANDARD_DEVIATION 11.60 • n=7 Participants
|
45.80 years
STANDARD_DEVIATION 10.09 • n=5 Participants
|
43.67 years
STANDARD_DEVIATION 11.47 • n=4 Participants
|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
25 Participants
n=5 Participants
|
25 Participants
n=7 Participants
|
25 Participants
n=5 Participants
|
75 Participants
n=4 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Sex: Female, Male
Female
|
13 Participants
n=5 Participants
|
15 Participants
n=7 Participants
|
14 Participants
n=5 Participants
|
42 Participants
n=4 Participants
|
|
Sex: Female, Male
Male
|
12 Participants
n=5 Participants
|
10 Participants
n=7 Participants
|
11 Participants
n=5 Participants
|
33 Participants
n=4 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
2 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Black or African American
|
14 Participants
n=5 Participants
|
11 Participants
n=7 Participants
|
13 Participants
n=5 Participants
|
38 Participants
n=4 Participants
|
|
Race (NIH/OMB)
White
|
11 Participants
n=5 Participants
|
11 Participants
n=7 Participants
|
11 Participants
n=5 Participants
|
33 Participants
n=4 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
25 Participants
n=5 Participants
|
25 Participants
n=7 Participants
|
24 Participants
n=5 Participants
|
74 Participants
n=4 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Region of Enrollment
United States
|
25 participants
n=5 Participants
|
25 participants
n=7 Participants
|
25 participants
n=5 Participants
|
75 participants
n=4 Participants
|
PRIMARY outcome
Timeframe: After 1 week of treatment (relative to baseline)To evaluate the effects of meclizine alone on ad lib smoking, the percent decrease in expired air carbon monoxide (CO) at the end of week 1 (relative to baseline) will be compared (using ANOVA) between each meclizine group and placebo.
Outcome measures
| Measure |
Control
n=18 Participants
Subjects in this group will take placebo meclizine daily for the three weeks prior to their quit date. Subjects will also apply a 21mg/24h nicotine patch daily starting in the second week of pre-quit treatment. Placebo meclizine will be administered in two doses each day.
Nicotine patches: Pre-Quit Period: During weeks two and three, participants will apply active 21mg/24h nicotine patches daily.
Post-Quit Period: Following the quit-day these participants will apply active nicotine patches daily using the following dose schedule: 21mg/24h for four weeks, 14mg/24h for one week, and 7mg/24h for one week.
|
25mg Meclizine
n=23 Participants
Subjects in this group will take 25mg of meclizine daily for the three weeks prior to their quit date. Subjects will also apply a 21mg/24h nicotine patch daily starting in the second week of pre-quit treatment. Meclizine will be administered in two doses each day.
Meclizine: Pre-Quit Period: In this group, participants will take meclizine daily during the three week pre-quit period. The meclizine will be taken in two doses daily, one capsule with breakfast and one with dinner.
Nicotine patches: Pre-Quit Period: During weeks two and three, participants will apply active 21mg/24h nicotine patches daily.
Post-Quit Period: Following the quit-day these participants will apply active nicotine patches daily using the following dose schedule: 21mg/24h for four weeks, 14mg/24h for one week, and 7mg/24h for one week.
|
50mg Meclizine
n=25 Participants
Subjects in this group will take 50mg of meclizine daily for the three weeks prior to their quit date. Subjects will also apply a 21mg/24h nicotine patch daily starting in the second week of pre-quit treatment. Meclizine will be administered in two doses each day.
Meclizine: Pre-Quit Period: In this group, participants will take meclizine daily during the three week pre-quit period. The meclizine will be taken in two doses daily, one capsule with breakfast and one with dinner.
Nicotine patches: Pre-Quit Period: During weeks two and three, participants will apply active 21mg/24h nicotine patches daily.
Post-Quit Period: Following the quit-day these participants will apply active nicotine patches daily using the following dose schedule: 21mg/24h for four weeks, 14mg/24h for one week, and 7mg/24h for one week.
|
|---|---|---|---|
|
Percentage of Change in Expired Air Carbon Monoxide (CO) at End of Week 1
|
1.73 percentage change
Standard Error 9.03
|
-14.11 percentage change
Standard Error 5.86
|
-.63 percentage change
Standard Error 6.85
|
PRIMARY outcome
Timeframe: After 3 weeks of treatment (relative to baseline)To evaluate the effects of meclizine as an augmentation treatment in conjunction with nicotine patch, the percent decrease in expired air carbon monoxide (CO) at the end of week 3 (relative to baseline) will be compared (using ANOVA) between each meclizine group and placebo.
Outcome measures
| Measure |
Control
n=18 Participants
Subjects in this group will take placebo meclizine daily for the three weeks prior to their quit date. Subjects will also apply a 21mg/24h nicotine patch daily starting in the second week of pre-quit treatment. Placebo meclizine will be administered in two doses each day.
Nicotine patches: Pre-Quit Period: During weeks two and three, participants will apply active 21mg/24h nicotine patches daily.
Post-Quit Period: Following the quit-day these participants will apply active nicotine patches daily using the following dose schedule: 21mg/24h for four weeks, 14mg/24h for one week, and 7mg/24h for one week.
|
25mg Meclizine
n=23 Participants
Subjects in this group will take 25mg of meclizine daily for the three weeks prior to their quit date. Subjects will also apply a 21mg/24h nicotine patch daily starting in the second week of pre-quit treatment. Meclizine will be administered in two doses each day.
Meclizine: Pre-Quit Period: In this group, participants will take meclizine daily during the three week pre-quit period. The meclizine will be taken in two doses daily, one capsule with breakfast and one with dinner.
Nicotine patches: Pre-Quit Period: During weeks two and three, participants will apply active 21mg/24h nicotine patches daily.
Post-Quit Period: Following the quit-day these participants will apply active nicotine patches daily using the following dose schedule: 21mg/24h for four weeks, 14mg/24h for one week, and 7mg/24h for one week.
|
50mg Meclizine
n=25 Participants
Subjects in this group will take 50mg of meclizine daily for the three weeks prior to their quit date. Subjects will also apply a 21mg/24h nicotine patch daily starting in the second week of pre-quit treatment. Meclizine will be administered in two doses each day.
Meclizine: Pre-Quit Period: In this group, participants will take meclizine daily during the three week pre-quit period. The meclizine will be taken in two doses daily, one capsule with breakfast and one with dinner.
Nicotine patches: Pre-Quit Period: During weeks two and three, participants will apply active 21mg/24h nicotine patches daily.
Post-Quit Period: Following the quit-day these participants will apply active nicotine patches daily using the following dose schedule: 21mg/24h for four weeks, 14mg/24h for one week, and 7mg/24h for one week.
|
|---|---|---|---|
|
Percentage of Change in Expired Air Carbon Monoxide (CO) at End of Week 3
|
-34.05 percentage change
Standard Error 11.83
|
-54.10 percentage change
Standard Error 5.41
|
-35.60 percentage change
Standard Error 8.72
|
SECONDARY outcome
Timeframe: weeks 3-6 post quit dateContinuous 4 week abstinence from smoking (weeks 3-6 post quit date), based on self-reported abstinence confirmed by expired air CO ≤8ppm, will be compared between each meclizine group and placebo, using logistic regression analyses
Outcome measures
| Measure |
Control
n=25 Participants
Subjects in this group will take placebo meclizine daily for the three weeks prior to their quit date. Subjects will also apply a 21mg/24h nicotine patch daily starting in the second week of pre-quit treatment. Placebo meclizine will be administered in two doses each day.
Nicotine patches: Pre-Quit Period: During weeks two and three, participants will apply active 21mg/24h nicotine patches daily.
Post-Quit Period: Following the quit-day these participants will apply active nicotine patches daily using the following dose schedule: 21mg/24h for four weeks, 14mg/24h for one week, and 7mg/24h for one week.
|
25mg Meclizine
n=25 Participants
Subjects in this group will take 25mg of meclizine daily for the three weeks prior to their quit date. Subjects will also apply a 21mg/24h nicotine patch daily starting in the second week of pre-quit treatment. Meclizine will be administered in two doses each day.
Meclizine: Pre-Quit Period: In this group, participants will take meclizine daily during the three week pre-quit period. The meclizine will be taken in two doses daily, one capsule with breakfast and one with dinner.
Nicotine patches: Pre-Quit Period: During weeks two and three, participants will apply active 21mg/24h nicotine patches daily.
Post-Quit Period: Following the quit-day these participants will apply active nicotine patches daily using the following dose schedule: 21mg/24h for four weeks, 14mg/24h for one week, and 7mg/24h for one week.
|
50mg Meclizine
n=25 Participants
Subjects in this group will take 50mg of meclizine daily for the three weeks prior to their quit date. Subjects will also apply a 21mg/24h nicotine patch daily starting in the second week of pre-quit treatment. Meclizine will be administered in two doses each day.
Meclizine: Pre-Quit Period: In this group, participants will take meclizine daily during the three week pre-quit period. The meclizine will be taken in two doses daily, one capsule with breakfast and one with dinner.
Nicotine patches: Pre-Quit Period: During weeks two and three, participants will apply active 21mg/24h nicotine patches daily.
Post-Quit Period: Following the quit-day these participants will apply active nicotine patches daily using the following dose schedule: 21mg/24h for four weeks, 14mg/24h for one week, and 7mg/24h for one week.
|
|---|---|---|---|
|
Number of Participants Completing the Continuous 4 Week Abstinence From Smoking
|
2 participants
Interval 0.25 to 6.5
|
7 participants
Interval 3.0 to 12.25
|
2 participants
Interval 0.25 to 6.5
|
SECONDARY outcome
Timeframe: After 1 week of treatment (relative to baseline)Population: Abstinent (n=2 "Control", 7 "25mg", 2 "50mg") Non-abstinent (n=16 "Control", 16 "25mg", 23 "50mg")
To further validate the association between a decrease in expired air CO before the quit date and subsequent abstinence, the decrease in expired air CO from baseline to week 1 (Session P2) will be compared between abstinent and non-abstinent smokers, using ANOVA.
Outcome measures
| Measure |
Control
n=18 Participants
Subjects in this group will take placebo meclizine daily for the three weeks prior to their quit date. Subjects will also apply a 21mg/24h nicotine patch daily starting in the second week of pre-quit treatment. Placebo meclizine will be administered in two doses each day.
Nicotine patches: Pre-Quit Period: During weeks two and three, participants will apply active 21mg/24h nicotine patches daily.
Post-Quit Period: Following the quit-day these participants will apply active nicotine patches daily using the following dose schedule: 21mg/24h for four weeks, 14mg/24h for one week, and 7mg/24h for one week.
|
25mg Meclizine
n=23 Participants
Subjects in this group will take 25mg of meclizine daily for the three weeks prior to their quit date. Subjects will also apply a 21mg/24h nicotine patch daily starting in the second week of pre-quit treatment. Meclizine will be administered in two doses each day.
Meclizine: Pre-Quit Period: In this group, participants will take meclizine daily during the three week pre-quit period. The meclizine will be taken in two doses daily, one capsule with breakfast and one with dinner.
Nicotine patches: Pre-Quit Period: During weeks two and three, participants will apply active 21mg/24h nicotine patches daily.
Post-Quit Period: Following the quit-day these participants will apply active nicotine patches daily using the following dose schedule: 21mg/24h for four weeks, 14mg/24h for one week, and 7mg/24h for one week.
|
50mg Meclizine
n=25 Participants
Subjects in this group will take 50mg of meclizine daily for the three weeks prior to their quit date. Subjects will also apply a 21mg/24h nicotine patch daily starting in the second week of pre-quit treatment. Meclizine will be administered in two doses each day.
Meclizine: Pre-Quit Period: In this group, participants will take meclizine daily during the three week pre-quit period. The meclizine will be taken in two doses daily, one capsule with breakfast and one with dinner.
Nicotine patches: Pre-Quit Period: During weeks two and three, participants will apply active 21mg/24h nicotine patches daily.
Post-Quit Period: Following the quit-day these participants will apply active nicotine patches daily using the following dose schedule: 21mg/24h for four weeks, 14mg/24h for one week, and 7mg/24h for one week.
|
|---|---|---|---|
|
Percentage of Change of CO at End of Week 1 When Comparing Abstinent Smokers Versus Non-abstinent Smokers
abstinent
|
5.00 percentage change
Standard Error 15.00
|
2.64 percentage change
Standard Error 20.56
|
-16.67 percentage change
Standard Error 16.67
|
|
Percentage of Change of CO at End of Week 1 When Comparing Abstinent Smokers Versus Non-abstinent Smokers
non-abstinent
|
1.32 percentage change
Standard Error 10.10
|
-17.64 percentage change
Standard Error 5.66
|
-5.37 percentage change
Standard Error 7.35
|
SECONDARY outcome
Timeframe: After 3 weeks of treatment (relative to baseline)Population: Abstinent (n=2 "Control", 7 "25mg", 2 "50mg") Non-abstinent (n=16 "Control", 16 "25mg", 23 "50mg")
To further validate the association between a decrease in expired air CO before the quit date and subsequent abstinence, the decrease in expired air CO from baseline to week 3 (Session P3) will be compared between abstinent and non-abstinent smokers, using ANOVA.
Outcome measures
| Measure |
Control
n=18 Participants
Subjects in this group will take placebo meclizine daily for the three weeks prior to their quit date. Subjects will also apply a 21mg/24h nicotine patch daily starting in the second week of pre-quit treatment. Placebo meclizine will be administered in two doses each day.
Nicotine patches: Pre-Quit Period: During weeks two and three, participants will apply active 21mg/24h nicotine patches daily.
Post-Quit Period: Following the quit-day these participants will apply active nicotine patches daily using the following dose schedule: 21mg/24h for four weeks, 14mg/24h for one week, and 7mg/24h for one week.
|
25mg Meclizine
n=23 Participants
Subjects in this group will take 25mg of meclizine daily for the three weeks prior to their quit date. Subjects will also apply a 21mg/24h nicotine patch daily starting in the second week of pre-quit treatment. Meclizine will be administered in two doses each day.
Meclizine: Pre-Quit Period: In this group, participants will take meclizine daily during the three week pre-quit period. The meclizine will be taken in two doses daily, one capsule with breakfast and one with dinner.
Nicotine patches: Pre-Quit Period: During weeks two and three, participants will apply active 21mg/24h nicotine patches daily.
Post-Quit Period: Following the quit-day these participants will apply active nicotine patches daily using the following dose schedule: 21mg/24h for four weeks, 14mg/24h for one week, and 7mg/24h for one week.
|
50mg Meclizine
n=25 Participants
Subjects in this group will take 50mg of meclizine daily for the three weeks prior to their quit date. Subjects will also apply a 21mg/24h nicotine patch daily starting in the second week of pre-quit treatment. Meclizine will be administered in two doses each day.
Meclizine: Pre-Quit Period: In this group, participants will take meclizine daily during the three week pre-quit period. The meclizine will be taken in two doses daily, one capsule with breakfast and one with dinner.
Nicotine patches: Pre-Quit Period: During weeks two and three, participants will apply active 21mg/24h nicotine patches daily.
Post-Quit Period: Following the quit-day these participants will apply active nicotine patches daily using the following dose schedule: 21mg/24h for four weeks, 14mg/24h for one week, and 7mg/24h for one week.
|
|---|---|---|---|
|
Percentage of Change of CO at End of Week 3 When Comparing Abstinent Smokers Versus Non-abstinent Smokers
abstinent
|
-47.50 percentage change
Standard Error 52.50
|
-82.77 percentage change
Standard Error 10.23
|
-56.76 percentage change
Standard Error 35.55
|
|
Percentage of Change of CO at End of Week 3 When Comparing Abstinent Smokers Versus Non-abstinent Smokers
non-abstinent
|
-32.13 percentage change
Standard Error 12.32
|
-47.72 percentage change
Standard Error 22.02
|
-33.38 percentage change
Standard Error 39.74
|
Adverse Events
Control
Serious events: 0 serious events
Other events: 14 other events
Deaths: 0 deaths
25mg Meclizine
Serious events: 0 serious events
Other events: 14 other events
Deaths: 0 deaths
50mg Meclizine
Serious events: 0 serious events
Other events: 15 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Control
n=19 participants at risk
Subjects in this group will take placebo meclizine daily for the three weeks prior to their quit date. Subjects will also apply a 21mg/24h nicotine patch daily starting in the second week of pre-quit treatment. Placebo meclizine will be administered in two doses each day.
Nicotine patches: Pre-Quit Period: During weeks two and three, participants will apply active 21mg/24h nicotine patches daily.
Post-Quit Period: Following the quit-day these participants will apply active nicotine patches daily using the following dose schedule: 21mg/24h for four weeks, 14mg/24h for one week, and 7mg/24h for one week.
|
25mg Meclizine
n=23 participants at risk
Subjects in this group will take 25mg of meclizine daily for the three weeks prior to their quit date. Subjects will also apply a 21mg/24h nicotine patch daily starting in the second week of pre-quit treatment. Meclizine will be administered in two doses each day.
Meclizine: Pre-Quit Period: In this group, participants will take meclizine daily during the three week pre-quit period. The meclizine will be taken in two doses daily, one capsule with breakfast and one with dinner.
Nicotine patches: Pre-Quit Period: During weeks two and three, participants will apply active 21mg/24h nicotine patches daily.
Post-Quit Period: Following the quit-day these participants will apply active nicotine patches daily using the following dose schedule: 21mg/24h for four weeks, 14mg/24h for one week, and 7mg/24h for one week.
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50mg Meclizine
n=25 participants at risk
Subjects in this group will take 50mg of meclizine daily for the three weeks prior to their quit date. Subjects will also apply a 21mg/24h nicotine patch daily starting in the second week of pre-quit treatment. Meclizine will be administered in two doses each day.
Meclizine: Pre-Quit Period: In this group, participants will take meclizine daily during the three week pre-quit period. The meclizine will be taken in two doses daily, one capsule with breakfast and one with dinner.
Nicotine patches: Pre-Quit Period: During weeks two and three, participants will apply active 21mg/24h nicotine patches daily.
Post-Quit Period: Following the quit-day these participants will apply active nicotine patches daily using the following dose schedule: 21mg/24h for four weeks, 14mg/24h for one week, and 7mg/24h for one week.
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|---|---|---|---|
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Gastrointestinal disorders
Nausea
|
31.6%
6/19 • Number of events 6 • Subjects were receiving study drugs for nine weeks. At each study session during this period subjects completed a questionnaire about side effects. Subjects were also told to contact us between study sessions if side effects were bothersome.
Eight subjects discontinued study participation after the first study session; therefore, no side effects data were collected. Six of these subjects were in the control group, two of these subjects were in the 25mg Meclizine group and none were in the 50mg Meclizine group.
|
0.00%
0/23 • Subjects were receiving study drugs for nine weeks. At each study session during this period subjects completed a questionnaire about side effects. Subjects were also told to contact us between study sessions if side effects were bothersome.
Eight subjects discontinued study participation after the first study session; therefore, no side effects data were collected. Six of these subjects were in the control group, two of these subjects were in the 25mg Meclizine group and none were in the 50mg Meclizine group.
|
8.0%
2/25 • Number of events 2 • Subjects were receiving study drugs for nine weeks. At each study session during this period subjects completed a questionnaire about side effects. Subjects were also told to contact us between study sessions if side effects were bothersome.
Eight subjects discontinued study participation after the first study session; therefore, no side effects data were collected. Six of these subjects were in the control group, two of these subjects were in the 25mg Meclizine group and none were in the 50mg Meclizine group.
|
|
Nervous system disorders
Headache
|
15.8%
3/19 • Number of events 3 • Subjects were receiving study drugs for nine weeks. At each study session during this period subjects completed a questionnaire about side effects. Subjects were also told to contact us between study sessions if side effects were bothersome.
Eight subjects discontinued study participation after the first study session; therefore, no side effects data were collected. Six of these subjects were in the control group, two of these subjects were in the 25mg Meclizine group and none were in the 50mg Meclizine group.
|
4.3%
1/23 • Number of events 1 • Subjects were receiving study drugs for nine weeks. At each study session during this period subjects completed a questionnaire about side effects. Subjects were also told to contact us between study sessions if side effects were bothersome.
Eight subjects discontinued study participation after the first study session; therefore, no side effects data were collected. Six of these subjects were in the control group, two of these subjects were in the 25mg Meclizine group and none were in the 50mg Meclizine group.
|
8.0%
2/25 • Number of events 2 • Subjects were receiving study drugs for nine weeks. At each study session during this period subjects completed a questionnaire about side effects. Subjects were also told to contact us between study sessions if side effects were bothersome.
Eight subjects discontinued study participation after the first study session; therefore, no side effects data were collected. Six of these subjects were in the control group, two of these subjects were in the 25mg Meclizine group and none were in the 50mg Meclizine group.
|
|
Gastrointestinal disorders
Diarrhea / Constipation
|
10.5%
2/19 • Number of events 2 • Subjects were receiving study drugs for nine weeks. At each study session during this period subjects completed a questionnaire about side effects. Subjects were also told to contact us between study sessions if side effects were bothersome.
Eight subjects discontinued study participation after the first study session; therefore, no side effects data were collected. Six of these subjects were in the control group, two of these subjects were in the 25mg Meclizine group and none were in the 50mg Meclizine group.
|
8.7%
2/23 • Number of events 2 • Subjects were receiving study drugs for nine weeks. At each study session during this period subjects completed a questionnaire about side effects. Subjects were also told to contact us between study sessions if side effects were bothersome.
Eight subjects discontinued study participation after the first study session; therefore, no side effects data were collected. Six of these subjects were in the control group, two of these subjects were in the 25mg Meclizine group and none were in the 50mg Meclizine group.
|
4.0%
1/25 • Number of events 1 • Subjects were receiving study drugs for nine weeks. At each study session during this period subjects completed a questionnaire about side effects. Subjects were also told to contact us between study sessions if side effects were bothersome.
Eight subjects discontinued study participation after the first study session; therefore, no side effects data were collected. Six of these subjects were in the control group, two of these subjects were in the 25mg Meclizine group and none were in the 50mg Meclizine group.
|
|
General disorders
Mouth / Throat Irritation
|
5.3%
1/19 • Number of events 1 • Subjects were receiving study drugs for nine weeks. At each study session during this period subjects completed a questionnaire about side effects. Subjects were also told to contact us between study sessions if side effects were bothersome.
Eight subjects discontinued study participation after the first study session; therefore, no side effects data were collected. Six of these subjects were in the control group, two of these subjects were in the 25mg Meclizine group and none were in the 50mg Meclizine group.
|
0.00%
0/23 • Subjects were receiving study drugs for nine weeks. At each study session during this period subjects completed a questionnaire about side effects. Subjects were also told to contact us between study sessions if side effects were bothersome.
Eight subjects discontinued study participation after the first study session; therefore, no side effects data were collected. Six of these subjects were in the control group, two of these subjects were in the 25mg Meclizine group and none were in the 50mg Meclizine group.
|
4.0%
1/25 • Number of events 1 • Subjects were receiving study drugs for nine weeks. At each study session during this period subjects completed a questionnaire about side effects. Subjects were also told to contact us between study sessions if side effects were bothersome.
Eight subjects discontinued study participation after the first study session; therefore, no side effects data were collected. Six of these subjects were in the control group, two of these subjects were in the 25mg Meclizine group and none were in the 50mg Meclizine group.
|
|
Gastrointestinal disorders
Heartburn
|
21.1%
4/19 • Number of events 4 • Subjects were receiving study drugs for nine weeks. At each study session during this period subjects completed a questionnaire about side effects. Subjects were also told to contact us between study sessions if side effects were bothersome.
Eight subjects discontinued study participation after the first study session; therefore, no side effects data were collected. Six of these subjects were in the control group, two of these subjects were in the 25mg Meclizine group and none were in the 50mg Meclizine group.
|
0.00%
0/23 • Subjects were receiving study drugs for nine weeks. At each study session during this period subjects completed a questionnaire about side effects. Subjects were also told to contact us between study sessions if side effects were bothersome.
Eight subjects discontinued study participation after the first study session; therefore, no side effects data were collected. Six of these subjects were in the control group, two of these subjects were in the 25mg Meclizine group and none were in the 50mg Meclizine group.
|
4.0%
1/25 • Number of events 1 • Subjects were receiving study drugs for nine weeks. At each study session during this period subjects completed a questionnaire about side effects. Subjects were also told to contact us between study sessions if side effects were bothersome.
Eight subjects discontinued study participation after the first study session; therefore, no side effects data were collected. Six of these subjects were in the control group, two of these subjects were in the 25mg Meclizine group and none were in the 50mg Meclizine group.
|
|
Respiratory, thoracic and mediastinal disorders
Coughing
|
21.1%
4/19 • Number of events 4 • Subjects were receiving study drugs for nine weeks. At each study session during this period subjects completed a questionnaire about side effects. Subjects were also told to contact us between study sessions if side effects were bothersome.
Eight subjects discontinued study participation after the first study session; therefore, no side effects data were collected. Six of these subjects were in the control group, two of these subjects were in the 25mg Meclizine group and none were in the 50mg Meclizine group.
|
8.7%
2/23 • Number of events 2 • Subjects were receiving study drugs for nine weeks. At each study session during this period subjects completed a questionnaire about side effects. Subjects were also told to contact us between study sessions if side effects were bothersome.
Eight subjects discontinued study participation after the first study session; therefore, no side effects data were collected. Six of these subjects were in the control group, two of these subjects were in the 25mg Meclizine group and none were in the 50mg Meclizine group.
|
12.0%
3/25 • Number of events 3 • Subjects were receiving study drugs for nine weeks. At each study session during this period subjects completed a questionnaire about side effects. Subjects were also told to contact us between study sessions if side effects were bothersome.
Eight subjects discontinued study participation after the first study session; therefore, no side effects data were collected. Six of these subjects were in the control group, two of these subjects were in the 25mg Meclizine group and none were in the 50mg Meclizine group.
|
|
Nervous system disorders
Irritability
|
10.5%
2/19 • Number of events 2 • Subjects were receiving study drugs for nine weeks. At each study session during this period subjects completed a questionnaire about side effects. Subjects were also told to contact us between study sessions if side effects were bothersome.
Eight subjects discontinued study participation after the first study session; therefore, no side effects data were collected. Six of these subjects were in the control group, two of these subjects were in the 25mg Meclizine group and none were in the 50mg Meclizine group.
|
13.0%
3/23 • Number of events 3 • Subjects were receiving study drugs for nine weeks. At each study session during this period subjects completed a questionnaire about side effects. Subjects were also told to contact us between study sessions if side effects were bothersome.
Eight subjects discontinued study participation after the first study session; therefore, no side effects data were collected. Six of these subjects were in the control group, two of these subjects were in the 25mg Meclizine group and none were in the 50mg Meclizine group.
|
12.0%
3/25 • Number of events 3 • Subjects were receiving study drugs for nine weeks. At each study session during this period subjects completed a questionnaire about side effects. Subjects were also told to contact us between study sessions if side effects were bothersome.
Eight subjects discontinued study participation after the first study session; therefore, no side effects data were collected. Six of these subjects were in the control group, two of these subjects were in the 25mg Meclizine group and none were in the 50mg Meclizine group.
|
|
Nervous system disorders
Difficulty Concentrating
|
10.5%
2/19 • Number of events 2 • Subjects were receiving study drugs for nine weeks. At each study session during this period subjects completed a questionnaire about side effects. Subjects were also told to contact us between study sessions if side effects were bothersome.
Eight subjects discontinued study participation after the first study session; therefore, no side effects data were collected. Six of these subjects were in the control group, two of these subjects were in the 25mg Meclizine group and none were in the 50mg Meclizine group.
|
0.00%
0/23 • Subjects were receiving study drugs for nine weeks. At each study session during this period subjects completed a questionnaire about side effects. Subjects were also told to contact us between study sessions if side effects were bothersome.
Eight subjects discontinued study participation after the first study session; therefore, no side effects data were collected. Six of these subjects were in the control group, two of these subjects were in the 25mg Meclizine group and none were in the 50mg Meclizine group.
|
4.0%
1/25 • Number of events 1 • Subjects were receiving study drugs for nine weeks. At each study session during this period subjects completed a questionnaire about side effects. Subjects were also told to contact us between study sessions if side effects were bothersome.
Eight subjects discontinued study participation after the first study session; therefore, no side effects data were collected. Six of these subjects were in the control group, two of these subjects were in the 25mg Meclizine group and none were in the 50mg Meclizine group.
|
|
Nervous system disorders
Drowsiness
|
5.3%
1/19 • Number of events 1 • Subjects were receiving study drugs for nine weeks. At each study session during this period subjects completed a questionnaire about side effects. Subjects were also told to contact us between study sessions if side effects were bothersome.
Eight subjects discontinued study participation after the first study session; therefore, no side effects data were collected. Six of these subjects were in the control group, two of these subjects were in the 25mg Meclizine group and none were in the 50mg Meclizine group.
|
21.7%
5/23 • Number of events 5 • Subjects were receiving study drugs for nine weeks. At each study session during this period subjects completed a questionnaire about side effects. Subjects were also told to contact us between study sessions if side effects were bothersome.
Eight subjects discontinued study participation after the first study session; therefore, no side effects data were collected. Six of these subjects were in the control group, two of these subjects were in the 25mg Meclizine group and none were in the 50mg Meclizine group.
|
12.0%
3/25 • Number of events 3 • Subjects were receiving study drugs for nine weeks. At each study session during this period subjects completed a questionnaire about side effects. Subjects were also told to contact us between study sessions if side effects were bothersome.
Eight subjects discontinued study participation after the first study session; therefore, no side effects data were collected. Six of these subjects were in the control group, two of these subjects were in the 25mg Meclizine group and none were in the 50mg Meclizine group.
|
|
Nervous system disorders
Fatigue
|
10.5%
2/19 • Number of events 2 • Subjects were receiving study drugs for nine weeks. At each study session during this period subjects completed a questionnaire about side effects. Subjects were also told to contact us between study sessions if side effects were bothersome.
Eight subjects discontinued study participation after the first study session; therefore, no side effects data were collected. Six of these subjects were in the control group, two of these subjects were in the 25mg Meclizine group and none were in the 50mg Meclizine group.
|
17.4%
4/23 • Number of events 4 • Subjects were receiving study drugs for nine weeks. At each study session during this period subjects completed a questionnaire about side effects. Subjects were also told to contact us between study sessions if side effects were bothersome.
Eight subjects discontinued study participation after the first study session; therefore, no side effects data were collected. Six of these subjects were in the control group, two of these subjects were in the 25mg Meclizine group and none were in the 50mg Meclizine group.
|
20.0%
5/25 • Number of events 5 • Subjects were receiving study drugs for nine weeks. At each study session during this period subjects completed a questionnaire about side effects. Subjects were also told to contact us between study sessions if side effects were bothersome.
Eight subjects discontinued study participation after the first study session; therefore, no side effects data were collected. Six of these subjects were in the control group, two of these subjects were in the 25mg Meclizine group and none were in the 50mg Meclizine group.
|
|
Nervous system disorders
Nightmares
|
21.1%
4/19 • Number of events 4 • Subjects were receiving study drugs for nine weeks. At each study session during this period subjects completed a questionnaire about side effects. Subjects were also told to contact us between study sessions if side effects were bothersome.
Eight subjects discontinued study participation after the first study session; therefore, no side effects data were collected. Six of these subjects were in the control group, two of these subjects were in the 25mg Meclizine group and none were in the 50mg Meclizine group.
|
34.8%
8/23 • Number of events 9 • Subjects were receiving study drugs for nine weeks. At each study session during this period subjects completed a questionnaire about side effects. Subjects were also told to contact us between study sessions if side effects were bothersome.
Eight subjects discontinued study participation after the first study session; therefore, no side effects data were collected. Six of these subjects were in the control group, two of these subjects were in the 25mg Meclizine group and none were in the 50mg Meclizine group.
|
12.0%
3/25 • Number of events 3 • Subjects were receiving study drugs for nine weeks. At each study session during this period subjects completed a questionnaire about side effects. Subjects were also told to contact us between study sessions if side effects were bothersome.
Eight subjects discontinued study participation after the first study session; therefore, no side effects data were collected. Six of these subjects were in the control group, two of these subjects were in the 25mg Meclizine group and none were in the 50mg Meclizine group.
|
|
Nervous system disorders
Vivid Dreams
|
36.8%
7/19 • Number of events 8 • Subjects were receiving study drugs for nine weeks. At each study session during this period subjects completed a questionnaire about side effects. Subjects were also told to contact us between study sessions if side effects were bothersome.
Eight subjects discontinued study participation after the first study session; therefore, no side effects data were collected. Six of these subjects were in the control group, two of these subjects were in the 25mg Meclizine group and none were in the 50mg Meclizine group.
|
52.2%
12/23 • Number of events 12 • Subjects were receiving study drugs for nine weeks. At each study session during this period subjects completed a questionnaire about side effects. Subjects were also told to contact us between study sessions if side effects were bothersome.
Eight subjects discontinued study participation after the first study session; therefore, no side effects data were collected. Six of these subjects were in the control group, two of these subjects were in the 25mg Meclizine group and none were in the 50mg Meclizine group.
|
36.0%
9/25 • Number of events 9 • Subjects were receiving study drugs for nine weeks. At each study session during this period subjects completed a questionnaire about side effects. Subjects were also told to contact us between study sessions if side effects were bothersome.
Eight subjects discontinued study participation after the first study session; therefore, no side effects data were collected. Six of these subjects were in the control group, two of these subjects were in the 25mg Meclizine group and none were in the 50mg Meclizine group.
|
|
Nervous system disorders
Insomnia
|
26.3%
5/19 • Number of events 6 • Subjects were receiving study drugs for nine weeks. At each study session during this period subjects completed a questionnaire about side effects. Subjects were also told to contact us between study sessions if side effects were bothersome.
Eight subjects discontinued study participation after the first study session; therefore, no side effects data were collected. Six of these subjects were in the control group, two of these subjects were in the 25mg Meclizine group and none were in the 50mg Meclizine group.
|
13.0%
3/23 • Number of events 3 • Subjects were receiving study drugs for nine weeks. At each study session during this period subjects completed a questionnaire about side effects. Subjects were also told to contact us between study sessions if side effects were bothersome.
Eight subjects discontinued study participation after the first study session; therefore, no side effects data were collected. Six of these subjects were in the control group, two of these subjects were in the 25mg Meclizine group and none were in the 50mg Meclizine group.
|
20.0%
5/25 • Number of events 5 • Subjects were receiving study drugs for nine weeks. At each study session during this period subjects completed a questionnaire about side effects. Subjects were also told to contact us between study sessions if side effects were bothersome.
Eight subjects discontinued study participation after the first study session; therefore, no side effects data were collected. Six of these subjects were in the control group, two of these subjects were in the 25mg Meclizine group and none were in the 50mg Meclizine group.
|
|
Skin and subcutaneous tissue disorders
Itching at Patch Site
|
63.2%
12/19 • Number of events 16 • Subjects were receiving study drugs for nine weeks. At each study session during this period subjects completed a questionnaire about side effects. Subjects were also told to contact us between study sessions if side effects were bothersome.
Eight subjects discontinued study participation after the first study session; therefore, no side effects data were collected. Six of these subjects were in the control group, two of these subjects were in the 25mg Meclizine group and none were in the 50mg Meclizine group.
|
26.1%
6/23 • Number of events 7 • Subjects were receiving study drugs for nine weeks. At each study session during this period subjects completed a questionnaire about side effects. Subjects were also told to contact us between study sessions if side effects were bothersome.
Eight subjects discontinued study participation after the first study session; therefore, no side effects data were collected. Six of these subjects were in the control group, two of these subjects were in the 25mg Meclizine group and none were in the 50mg Meclizine group.
|
28.0%
7/25 • Number of events 7 • Subjects were receiving study drugs for nine weeks. At each study session during this period subjects completed a questionnaire about side effects. Subjects were also told to contact us between study sessions if side effects were bothersome.
Eight subjects discontinued study participation after the first study session; therefore, no side effects data were collected. Six of these subjects were in the control group, two of these subjects were in the 25mg Meclizine group and none were in the 50mg Meclizine group.
|
|
Skin and subcutaneous tissue disorders
Rash at Patch Site
|
36.8%
7/19 • Number of events 10 • Subjects were receiving study drugs for nine weeks. At each study session during this period subjects completed a questionnaire about side effects. Subjects were also told to contact us between study sessions if side effects were bothersome.
Eight subjects discontinued study participation after the first study session; therefore, no side effects data were collected. Six of these subjects were in the control group, two of these subjects were in the 25mg Meclizine group and none were in the 50mg Meclizine group.
|
13.0%
3/23 • Number of events 3 • Subjects were receiving study drugs for nine weeks. At each study session during this period subjects completed a questionnaire about side effects. Subjects were also told to contact us between study sessions if side effects were bothersome.
Eight subjects discontinued study participation after the first study session; therefore, no side effects data were collected. Six of these subjects were in the control group, two of these subjects were in the 25mg Meclizine group and none were in the 50mg Meclizine group.
|
4.0%
1/25 • Number of events 1 • Subjects were receiving study drugs for nine weeks. At each study session during this period subjects completed a questionnaire about side effects. Subjects were also told to contact us between study sessions if side effects were bothersome.
Eight subjects discontinued study participation after the first study session; therefore, no side effects data were collected. Six of these subjects were in the control group, two of these subjects were in the 25mg Meclizine group and none were in the 50mg Meclizine group.
|
|
General disorders
Rash Distant from Patch Site
|
10.5%
2/19 • Number of events 2 • Subjects were receiving study drugs for nine weeks. At each study session during this period subjects completed a questionnaire about side effects. Subjects were also told to contact us between study sessions if side effects were bothersome.
Eight subjects discontinued study participation after the first study session; therefore, no side effects data were collected. Six of these subjects were in the control group, two of these subjects were in the 25mg Meclizine group and none were in the 50mg Meclizine group.
|
4.3%
1/23 • Number of events 1 • Subjects were receiving study drugs for nine weeks. At each study session during this period subjects completed a questionnaire about side effects. Subjects were also told to contact us between study sessions if side effects were bothersome.
Eight subjects discontinued study participation after the first study session; therefore, no side effects data were collected. Six of these subjects were in the control group, two of these subjects were in the 25mg Meclizine group and none were in the 50mg Meclizine group.
|
0.00%
0/25 • Subjects were receiving study drugs for nine weeks. At each study session during this period subjects completed a questionnaire about side effects. Subjects were also told to contact us between study sessions if side effects were bothersome.
Eight subjects discontinued study participation after the first study session; therefore, no side effects data were collected. Six of these subjects were in the control group, two of these subjects were in the 25mg Meclizine group and none were in the 50mg Meclizine group.
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Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place