Meclizine as a Potential Smoking Cessation Treatment
Condition: Smoking Cessation
Intervention: Meclizine; Nicotine Patch; Placebo
Intervention description: 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.; 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.; 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.
Intervention MeSH terms: Meclizine; Nicotine
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 146.0
Sex: All
Minimum age: 18 Years
Maximum age: 65 Years
Healthy volunteers: No
Keywords: Smoking Cessation; Cigarette Smoking; Meclizine; Nicotine Patch

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.
    

Eligibility 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.