Meclizine as a Potential Smoking Cessation Treatment

Smoking Cessation Clinical Trial

Official title:

Meclizine as a Potential Smoking Cessation Treatment

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01443858
• Other study ID #: Pro00030282
• Status: Completed
• Phase: Phase 2
• First received: September 29, 2011
• Last updated: July 29, 2014
• Start date: August 2011
• Est. completion date: July 2013

Study information

• Verified date: July 2014
• Source: Duke University
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 146
• Est. completion date: July 2013
• Est. primary completion date: December 2012
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 65 Years

Eligibility

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.

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Smoking Cessation

Intervention

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.
• 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.
• 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.

Locations

Country	Name	City	State
United States	Duke Center for Nicotine and Smoking Cessation Research	Charlotte	North Carolina
United States	Duke Center for Nicotine and Smoking Cessation Research	Durham	North Carolina
United States	Duke Center for Nicotine and Smoking Cessation Research	Raleigh	North Carolina
United States	Duke Center for Nicotine and Smoking Cessation Research	Winston-Salem	North Carolina

Sponsors (2)

Lead Sponsor	Collaborator
Duke University	Philip Morris USA, Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Percentage of Change in Expired Air Carbon Monoxide (CO) at End of Week 1	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.	After 1 week of treatment (relative to baseline)	No
Primary	Percentage of Change in Expired Air Carbon Monoxide (CO) at End of Week 3	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.	After 3 weeks of treatment (relative to baseline)	No
Secondary	Number of Participants Completing the Continuous 4 Week Abstinence From Smoking	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	weeks 3-6 post quit date	No
Secondary	Percentage of Change of CO at End of Week 1 When Comparing Abstinent Smokers Versus Non-abstinent Smokers	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.	After 1 week of treatment (relative to baseline)	No
Secondary	Percentage of Change of CO at End of Week 3 When Comparing Abstinent Smokers Versus Non-abstinent Smokers	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.	After 3 weeks of treatment (relative to baseline)	No