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Meclizine as a Potential Smoking Cessation Treatment

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ClinicalTrials.gov Identifier: NCT01443858
Recruitment Status : Completed
First Posted : September 30, 2011
Results First Posted : May 8, 2014
Last Update Posted : August 1, 2014
Sponsor:
Collaborator:
Philip Morris USA, Inc.
Information provided by (Responsible Party):
Duke University

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Double (Participant, Investigator);   Primary Purpose: Treatment
Condition Smoking Cessation
Interventions Drug: Meclizine
Drug: Nicotine Patch
Drug: Placebo
Enrollment 146
Recruitment Details 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.
Pre-assignment Details  
Arm/Group Title Control 25mg Meclizine 50mg Meclizine
Hide Arm/Group Description

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.

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.

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.

Period Title: Overall Study
Started 25 25 25
Completed 10 12 18
Not Completed 15 13 7
Reason Not Completed
Withdrawal by Subject             9             8             5
Lack of Efficacy             1             0             0
Lost to Follow-up             5             5             2
Arm/Group Title Control 25mg Meclizine 50mg Meclizine Total
Hide Arm/Group Description

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.

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.

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 of all reporting groups
Overall Number of Baseline Participants 25 25 25 75
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 25 participants 25 participants 25 participants 75 participants
42.80  (12.3) 42.40  (11.60) 45.80  (10.09) 43.67  (11.47)
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 25 participants 25 participants 25 participants 75 participants
<=18 years
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Between 18 and 65 years
25
 100.0%
25
 100.0%
25
 100.0%
75
 100.0%
>=65 years
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 25 participants 25 participants 25 participants 75 participants
Female
13
  52.0%
15
  60.0%
14
  56.0%
42
  56.0%
Male
12
  48.0%
10
  40.0%
11
  44.0%
33
  44.0%
Race (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 25 participants 25 participants 25 participants 75 participants
American Indian or Alaska Native
0
   0.0%
1
   4.0%
1
   4.0%
2
   2.7%
Asian
0
   0.0%
1
   4.0%
0
   0.0%
1
   1.3%
Native Hawaiian or Other Pacific Islander
0
   0.0%
1
   4.0%
0
   0.0%
1
   1.3%
Black or African American
14
  56.0%
11
  44.0%
13
  52.0%
38
  50.7%
White
11
  44.0%
11
  44.0%
11
  44.0%
33
  44.0%
More than one race
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Unknown or Not Reported
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Ethnicity (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 25 participants 25 participants 25 participants 75 participants
Hispanic or Latino
0
   0.0%
0
   0.0%
1
   4.0%
1
   1.3%
Not Hispanic or Latino
25
 100.0%
25
 100.0%
24
  96.0%
74
  98.7%
Unknown or Not Reported
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 25 participants 25 participants 25 participants 75 participants
25 25 25 75
1.Primary Outcome
Title Percentage of Change in Expired Air Carbon Monoxide (CO) at End of Week 1
Hide Description 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.
Time Frame After 1 week of treatment (relative to baseline)
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Control 25mg Meclizine 50mg Meclizine
Hide Arm/Group Description:

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.

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.

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 Number of Participants Analyzed 18 23 25
Mean (Standard Error)
Unit of Measure: percentage change
1.73  (9.03) -14.11  (5.86) -.63  (6.85)
2.Primary Outcome
Title Percentage of Change in Expired Air Carbon Monoxide (CO) at End of Week 3
Hide Description 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.
Time Frame After 3 weeks of treatment (relative to baseline)
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Control 25mg Meclizine 50mg Meclizine
Hide Arm/Group Description:

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.

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.

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 Number of Participants Analyzed 18 23 25
Mean (Standard Error)
Unit of Measure: percentage change
-34.05  (11.83) -54.10  (5.41) -35.60  (8.72)
3.Secondary Outcome
Title Number of Participants Completing the Continuous 4 Week Abstinence From Smoking
Hide Description Continuous 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
Time Frame weeks 3-6 post quit date
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Control 25mg Meclizine 50mg Meclizine
Hide Arm/Group Description:

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.

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.

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 Number of Participants Analyzed 25 25 25
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: participants
2
(.25 to 6.5)
7
(3.00 to 12.25)
2
(.25 to 6.5)
4.Secondary Outcome
Title Percentage of Change of CO at End of Week 1 When Comparing Abstinent Smokers Versus Non-abstinent Smokers
Hide Description 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.
Time Frame After 1 week of treatment (relative to baseline)
Hide Outcome Measure Data
Hide Analysis Population Description
Abstinent (n=2 "Control", 7 "25mg", 2 "50mg") Non-abstinent (n=16 "Control", 16 "25mg", 23 "50mg")
Arm/Group Title Control 25mg Meclizine 50mg Meclizine
Hide Arm/Group Description:

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.

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.

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 Number of Participants Analyzed 18 23 25
Mean (Standard Error)
Unit of Measure: percentage change
abstinent 5.00  (15.00) 2.64  (20.56) -16.67  (16.67)
non-abstinent 1.32  (10.10) -17.64  (5.66) -5.37  (7.35)
5.Secondary Outcome
Title Percentage of Change of CO at End of Week 3 When Comparing Abstinent Smokers Versus Non-abstinent Smokers
Hide Description 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.
Time Frame After 3 weeks of treatment (relative to baseline)
Hide Outcome Measure Data
Hide Analysis Population Description
Abstinent (n=2 "Control", 7 "25mg", 2 "50mg") Non-abstinent (n=16 "Control", 16 "25mg", 23 "50mg")
Arm/Group Title Control 25mg Meclizine 50mg Meclizine
Hide Arm/Group Description:

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.

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.

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 Number of Participants Analyzed 18 23 25
Mean (Standard Error)
Unit of Measure: percentage change
abstinent -47.50  (52.50) -82.77  (10.23) -56.76  (35.55)
non-abstinent -32.13  (12.32) -47.72  (22.02) -33.38  (39.74)
Time Frame 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.
Adverse Event Reporting Description 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.
 
Arm/Group Title Control 25mg Meclizine 50mg Meclizine
Hide Arm/Group Description

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.

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.

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.

All-Cause Mortality
Control 25mg Meclizine 50mg Meclizine
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   --/--      --/--      --/--    
Show Serious Adverse Events Hide Serious Adverse Events
Control 25mg Meclizine 50mg Meclizine
Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   0/19 (0.00%)      0/23 (0.00%)      0/25 (0.00%)    
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Control 25mg Meclizine 50mg Meclizine
Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   14/19 (73.68%)      14/23 (60.87%)      15/25 (60.00%)    
Gastrointestinal disorders       
Nausea   6/19 (31.58%)  6 0/23 (0.00%)  0 2/25 (8.00%)  2
Diarrhea / Constipation   2/19 (10.53%)  2 2/23 (8.70%)  2 1/25 (4.00%)  1
Heartburn   4/19 (21.05%)  4 0/23 (0.00%)  0 1/25 (4.00%)  1
General disorders       
Mouth / Throat Irritation   1/19 (5.26%)  1 0/23 (0.00%)  0 1/25 (4.00%)  1
Rash Distant from Patch Site   2/19 (10.53%)  2 1/23 (4.35%)  1 0/25 (0.00%)  0
Nervous system disorders       
Headache   3/19 (15.79%)  3 1/23 (4.35%)  1 2/25 (8.00%)  2
Irritability   2/19 (10.53%)  2 3/23 (13.04%)  3 3/25 (12.00%)  3
Difficulty Concentrating   2/19 (10.53%)  2 0/23 (0.00%)  0 1/25 (4.00%)  1
Drowsiness   1/19 (5.26%)  1 5/23 (21.74%)  5 3/25 (12.00%)  3
Fatigue   2/19 (10.53%)  2 4/23 (17.39%)  4 5/25 (20.00%)  5
Nightmares   4/19 (21.05%)  4 8/23 (34.78%)  9 3/25 (12.00%)  3
Vivid Dreams   7/19 (36.84%)  8 12/23 (52.17%)  12 9/25 (36.00%)  9
Insomnia   5/19 (26.32%)  6 3/23 (13.04%)  3 5/25 (20.00%)  5
Respiratory, thoracic and mediastinal disorders       
Coughing   4/19 (21.05%)  4 2/23 (8.70%)  2 3/25 (12.00%)  3
Skin and subcutaneous tissue disorders       
Itching at Patch Site   12/19 (63.16%)  16 6/23 (26.09%)  7 7/25 (28.00%)  7
Rash at Patch Site   7/19 (36.84%)  10 3/23 (13.04%)  3 1/25 (4.00%)  1
Indicates events were collected by systematic assessment
Certain Agreements
All Principal Investigators ARE employed by the organization sponsoring the study.
Results Point of Contact
Name/Title: Dr. Jed E. Rose
Organization: Duke Center for Smoking Cessation
Phone: 919-668-5055
Responsible Party: Duke University
ClinicalTrials.gov Identifier: NCT01443858     History of Changes
Other Study ID Numbers: Pro00030282
First Submitted: September 29, 2011
First Posted: September 30, 2011
Results First Submitted: April 7, 2014
Results First Posted: May 8, 2014
Last Update Posted: August 1, 2014