Meclizine as a Potential Smoking Cessation Treatment

Completed · Phase 2 · Has a placebo group

Conditions studied: Smoking Cessation

In brief

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.

Key facts

Study ID

NCT01443858

Run by

Duke University

People needed

146

Starts

2011-08-01

Expected to finish

2013-07-01

Last updated by the study team

2014-08-01

Who can join

Age: 18 and older, up to 65. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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).

You may not qualify if…

• 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;

Where it is running

• 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, United States

Full record on ClinicalTrials.gov

Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.