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
  Purpose

The purpose of this study is to evaluate whether meclizine, an antihistamine used to prevent or treat motion sickness, can help smokers quit smoking. This study will also investigate the potential relationship between genes you have inherited and success in quitting smoking.


Condition Intervention Phase
Smoking Cessation
Drug: Meclizine
Drug: Nicotine Patch
Drug: Placebo
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
Official Title: Meclizine as a Potential Smoking Cessation Treatment

Resource links provided by NLM:


Further study details as provided by Duke University:

Primary Outcome Measures:
  • Percentage of Change in Expired Air Carbon Monoxide (CO) at End of Week 1 [ Time Frame: After 1 week of treatment (relative to baseline) ] [ Designated as safety issue: No ]
    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.

  • Percentage of Change in Expired Air Carbon Monoxide (CO) at End of Week 3 [ Time Frame: After 3 weeks of treatment (relative to baseline) ] [ Designated as safety issue: No ]
    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.


Secondary Outcome Measures:
  • Number of Participants Completing the Continuous 4 Week Abstinence From Smoking [ Time Frame: weeks 3-6 post quit date ] [ Designated as safety issue: No ]
    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

  • 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) ] [ Designated as safety issue: No ]
    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.

  • 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) ] [ Designated as safety issue: No ]
    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.


Enrollment: 146
Study Start Date: August 2011
Study Completion Date: July 2013
Primary Completion Date: December 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Placebo + Nicotine Patch
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.
Drug: Nicotine Patch

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.

Other Name: Nicoderm
Drug: Placebo
Pre-Quit Period: In this group, participants will take placebo capsules daily during the three week pre-quit period. The placebo will be taken in two doses daily, one capsule with breakfast and one with dinner.
Experimental: 25mg Meclizine + Nicotine Patch
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.
Drug: 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.
Other Name: Antivert
Drug: Nicotine Patch

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.

Other Name: Nicoderm
Experimental: 50mg Meclizine + Nicotine Patch
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.
Drug: 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.
Other Name: Antivert
Drug: Nicotine Patch

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.

Other Name: Nicoderm

  Eligibility

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Have no known serious medical conditions;
  • Are 18-65 years old;
  • Smoke an average of at least 10 cigarettes per day;
  • Have smoked at least one cumulative year;
  • Have an afternoon expired air carbon monoxide (CO) reading of at least 10ppm;
  • Express a desire to quit smoking in the next thirty days.
  • Potential subjects must agree to use acceptable contraception during their participation in this study.

Potential subjects must agree to avoid the following during their participation in this study:

  • participation in any other nicotine-related modification strategy outside of this protocol;
  • use of tobacco products other than cigarettes, including pipe tobacco, cigars, e-cigarettes, snuff, and chewing tobacco;
  • use of experimental (investigational) drugs or devices;
  • use of illegal drugs;
  • use of opiate medications
  • use of anti-histamines;
  • use of alcohol (during first three weeks of study participation).

Exclusion Criteria:

  • Inability to attend all required experimental sessions;
  • Hypertension (systolic >140 mm Hg, diastolic >100 mm Hg, coupled with a history of hypertension); subjects with no previous diagnosis of hypertension may have a screening blood pressure up to 160/100.
  • Hypotension with symptoms (systolic <90 mm Hg, diastolic <60 mm Hg).
  • Participants with a history of hypertension may, however, be allowed to participate in the study if the study physician or physician assistant determines that the condition is stable, controlled by medication, and in no way jeopardizes the individual's safety.
  • Coronary heart disease;
  • Lifetime history of heart attack;
  • Cardiac rhythm disorder (irregular heart rhythm);
  • Chest pains (unless history, exam, and ECG clearly indicate a non-cardiac source);
  • Cardiac (heart) disorder (including but not limited to valvular heart disease, heart murmur, heart failure);
  • History of skin allergy;
  • Active skin disorder (e.g., psoriasis) within the last five years, except minor skin conditions (including but not limited to facial acne, minor localized infections, and superficial minor wounds);
  • Liver or kidney disorder (except kidney stones, gallstones);
  • Gastrointestinal problems or disease other than gastroesophageal reflux or heartburn;
  • Active ulcers in the past 30 days;
  • Currently symptomatic lung disorder/disease (including but not limited to chronic obstructive pulmonary disease (COPD), emphysema, and asthma);
  • Brain abnormality (including but not limited to stroke, brain tumor, head injury and seizure disorder);
  • Migraine headaches that occur more frequently than once per week;
  • Recent, unexplained fainting spells;
  • Problems giving blood samples;
  • Diabetes treated with insulin; non-insulin treated diabetes (unless glucose is less than 180mg/dcl and HbA1c is less than 7%);
  • Current cancer or treatment for cancer in the past six months (except basal or squamous cell skin cancer);
  • Other major medical condition;
  • Current psychiatric disease (with the exception of anxiety disorders, obsessive compulsive disorder (OCD) and ADHD);
  • Current depression;
  • Bulimia or anorexia;
  • Pregnant or nursing;
  • Smokes more than one cigar a month;
  • Regular alcohol use;
  • Significant adverse reaction to nicotine patches or meclizine in the past.
  • Current participation or recent participation (in the past 30 days) in another smoking study at our center or another research facility.
  • Current participation in another research study.

Use (within the past 30 days) of:

  • Illegal drugs (or if the urine drug screen is positive),
  • Experimental (investigational) drugs;
  • Psychiatric medications including antidepressants, anti-psychotics or any other medications that are known to affect smoking cessation (e.g. clonidine);
  • Smokeless tobacco (chewing tobacco, snuff), pipes or e-cigarettes;
  • Wellbutrin, bupropion, Zyban, Chantix, varenicline, nicotine replacement therapy or any other smoking cessation aid.

Use (within the past 14 days) of:

  • Opiate medications for pain or sleep (non-opiate medication for pain or sleep will be allowed);
  • Benzodiazepines, antihistamines or other drugs with significant sedating or anticholinergic activity that may interact with meclizine.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01443858

Locations
United States, North Carolina
Duke Center for Nicotine and Smoking Cessation Research
Charlotte, North Carolina, United States, 28210
Duke Center for Nicotine and Smoking Cessation Research
Durham, North Carolina, United States, 27705
Duke Center for Nicotine and Smoking Cessation Research
Raleigh, North Carolina, United States, 27609
Duke Center for Nicotine and Smoking Cessation Research
Winston-Salem, North Carolina, United States, 27103
Sponsors and Collaborators
Duke University
Philip Morris USA, Inc.
Investigators
Principal Investigator: Jed E Rose, Ph.D. Duke University
  More Information

No publications provided

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

Keywords provided by Duke University:
Smoking Cessation
Cigarette Smoking
Meclizine
Nicotine Patch

Additional relevant MeSH terms:
Meclizine
Nicotine
Antiemetics
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Pharmacologic Actions
Central Nervous System Agents
Therapeutic Uses
Gastrointestinal Agents
Histamine H1 Antagonists
Histamine Antagonists
Histamine Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Anti-Allergic Agents
Ganglionic Stimulants
Nicotinic Agonists
Cholinergic Agonists
Cholinergic Agents

ClinicalTrials.gov processed this record on August 26, 2014