Meclizine as a Potential Smoking Cessation Treatment

Phase 2

Completed

Conditions: Smoking Cessation

Interventions: Drug: Meclizine
Drug: Nicotine Patch
Drug: Placebo

Registration Number: NCT01443858

Lead Sponsor: Duke University

Brief 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.

Detailed Description: Not available

Recruitment & Eligibility

Status: COMPLETED

Sex: All

Target Recruitment: 146

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

Study Type: INTERVENTIONAL

Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
25mg Meclizine + Nicotine Patch	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.
Placebo + Nicotine Patch	Placebo	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.
Placebo + Nicotine Patch	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.
50mg Meclizine + Nicotine Patch	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.
25mg Meclizine + Nicotine Patch	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.
50mg Meclizine + Nicotine Patch	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.

Primary Outcome Measures

Name	Time	Method
Percentage of Change in Expired Air Carbon Monoxide (CO) at End of Week 1	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.
Percentage of Change in Expired Air Carbon Monoxide (CO) at End of Week 3	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.

Secondary Outcome Measures

Name	Time	Method
Number of Participants Completing the Continuous 4 Week Abstinence From Smoking	weeks 3-6 post quit date	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	After 1 week of treatment (relative to baseline)	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	After 3 weeks of treatment (relative to baseline)	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.