Clinical trial NCT01443858: Meclizine as a Potential Smoking Cessation Treatment
Official title: Meclizine as a Potential Smoking Cessation Treatment
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Smoking Cessation
Keywords: Smoking Cessation
Cigarette Smoking
Meclizine
Nicotine Patch
Lead sponsor: Duke University
Sponsor class: OTHER
Collaborators: name: Philip Morris USA, Inc.
First posted: 2011-09-30
Enrollment: 146
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


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.

Primary outcomes:
measure: Percentage of Change in Expired Air Carbon Monoxide (CO) at End of Week 1
timeFrame: After 1 week of treatment (relative to baseline)
measure: Percentage of Change in Expired Air Carbon Monoxide (CO) at End of Week 3
timeFrame: After 3 weeks of treatment (relative to baseline)
Secondary outcomes:
measure: Number of Participants Completing the Continuous 4 Week Abstinence From Smoking
timeFrame: weeks 3-6 post quit date
measure: Percentage of Change of CO at End of Week 1 When Comparing Abstinent Smokers Versus Non-abstinent Smokers
timeFrame: After 1 week of treatment (relative to baseline)
measure: Percentage of Change of CO at End of Week 3 When Comparing Abstinent Smokers Versus Non-abstinent Smokers
timeFrame: After 3 weeks of treatment (relative to baseline)
Other outcomes:
Locations:
city: Charlotte
country: United States
facility: Duke Center for Nicotine and Smoking Cessation Research
state: North Carolina
city: Durham
country: United States
facility: Duke Center for Nicotine and Smoking Cessation Research
state: North Carolina
city: Raleigh
country: United States
facility: Duke Center for Nicotine and Smoking Cessation Research
state: North Carolina
city: Winston-Salem
country: United States
facility: Duke Center for Nicotine and Smoking Cessation Research
state: North Carolina
Study officials:
affiliation: Duke University
name: Jed E Rose, Ph.D.
role: PRINCIPAL_INVESTIGATOR
References: