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Meclizine as a Potential Smoking Cessation Treatment

This study has been completed.
Sponsor:
Collaborator:
Philip Morris USA, Inc.
Information provided by (Responsible Party):
Duke University
ClinicalTrials.gov Identifier:
NCT01443858
First received: September 29, 2011
Last updated: July 29, 2014
Last verified: July 2014
Results First Received: April 7, 2014  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Efficacy Study;   Intervention Model: Parallel Assignment;   Masking: Double Blind (Subject, Investigator);   Primary Purpose: Treatment
Condition: Smoking Cessation
Interventions: Drug: Meclizine
Drug: Nicotine Patch
Drug: Placebo

  Participant Flow
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Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
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
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
No text entered.

Reporting Groups
  Description
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.


Participant Flow:   Overall Study
    Control   25mg Meclizine   50mg Meclizine
STARTED   25   25   25 
COMPLETED   10   12   18 
NOT COMPLETED   15   13   7 
Withdrawal by Subject                9                8                5 
Lack of Efficacy                1                0                0 
Lost to Follow-up                5                5                2 



  Baseline Characteristics
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Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
No text entered.

Reporting Groups
  Description
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.

Total Total of all reporting groups

Baseline Measures
   Control   25mg Meclizine   50mg Meclizine   Total 
Overall Participants Analyzed 
[Units: Participants]
 25   25   25   75 
Age 
[Units: Years]
Mean (Standard Deviation)
 42.80  (12.3)   42.40  (11.60)   45.80  (10.09)   43.67  (11.47) 
Age 
[Units: Participants]
       
<=18 years   0   0   0   0 
Between 18 and 65 years   25   25   25   75 
>=65 years   0   0   0   0 
Gender 
[Units: Participants]
       
Female   13   15   14   42 
Male   12   10   11   33 
Race (NIH/OMB) 
[Units: Participants]
       
American Indian or Alaska Native   0   1   1   2 
Asian   0   1   0   1 
Native Hawaiian or Other Pacific Islander   0   1   0   1 
Black or African American   14   11   13   38 
White   11   11   11   33 
More than one race   0   0   0   0 
Unknown or Not Reported   0   0   0   0 
Ethnicity (NIH/OMB) 
[Units: Participants]
       
Hispanic or Latino   0   0   1   1 
Not Hispanic or Latino   25   25   24   74 
Unknown or Not Reported   0   0   0   0 
Region of Enrollment 
[Units: Participants]
       
United States   25   25   25   75 


  Outcome Measures
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1.  Primary:   Percentage of Change in Expired Air Carbon Monoxide (CO) at End of Week 1   [ Time Frame: After 1 week of treatment (relative to baseline) ]

2.  Primary:   Percentage of Change in Expired Air Carbon Monoxide (CO) at End of Week 3   [ Time Frame: After 3 weeks of treatment (relative to baseline) ]

3.  Secondary:   Number of Participants Completing the Continuous 4 Week Abstinence From Smoking   [ Time Frame: weeks 3-6 post quit date ]

4.  Secondary:   Percentage of Change of CO at End of Week 1 When Comparing Abstinent Smokers Versus Non-abstinent Smokers   [ Time Frame: After 1 week of treatment (relative to baseline) ]

5.  Secondary:   Percentage of Change of CO at End of Week 3 When Comparing Abstinent Smokers Versus Non-abstinent Smokers   [ Time Frame: After 3 weeks of treatment (relative to baseline) ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
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Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
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  More Information
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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
e-mail: jed.rose@duke.edu



Responsible Party: Duke University
ClinicalTrials.gov Identifier: NCT01443858     History of Changes
Other Study ID Numbers: Pro00030282
Study First Received: September 29, 2011
Results First Received: April 7, 2014
Last Updated: July 29, 2014
Health Authority: United States: Institutional Review Board