Evaluation of Moclobemide, a Reversible MAO-A Inhibitor, as an Adjunct to Nicotine Replacement Therapy in Female Smokers

Inclusion criteria

• Have no known serious medical conditions;
• Female;
• Are 18-65 years old;
• Smoke an average of at least 20 cigarettes per day;
• Have smoked at least one cumulative year;
• Have a Fagerstrom Test for Nicotine Dependence score of at least 5;
• Have an expired air carbon monoxide (CO) reading of at least 10ppm;
• Able to read and understand English;
• Express a desire to quit smoking in the next thirty days.

Potential subjects must agree to avoid the following during their participation in this study:

• excessive alcohol consumption;
• use of other antidepressants;
• general anesthesia;
• 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;
• cimetidine;
• Tyramine rich foods;
• use of opiate medications.

Exclusion criteria

• Hypertension;
• Hypotension with symptoms;
• Coronary heart disease;
• Lifetime history of heart attack;
• Cardiac rhythm disorder;
• Chest pains;
• Cardiac (heart) disorder;
• Active skin disorder;
• Liver or kidney disorder;
• Gastrointestinal problems or disease other than gastroesophageal reflux or heartburn;
• Active ulcers in the past 30 days;
• Currently Symptomatic lung disorder/disease;
• Brain abnormality;
• Migraine headaches that occur more frequently than once per week;
• Recent, unexplained fainting spells;
• Problems giving blood samples;
• Diabetes (unless controlled by diet and exercise alone);
• Current cancer or treatment for cancer in the past six;
• Other major medical condition;
• Current psychiatric disease;
• Suicidal ideation (within the past 10 years) or lifetime occurrence of attempted suicide;
• Current depression;
• Bulimia or anorexia;
• Use (within the past 45 days) of psychiatric medications including antidepressants and anti-psychotics;
• Use (within the past 30 days) of:

• Illegal drugs (or if the urine drug screen is positive for tetrahydrocannabinol (THC), Cocaine, Amphetamine, Opiates, Methamphetamines, phencyclidine (PCP), Benzodiazepines, or Barbiturates),
• Experimental (investigational) drugs;
• Any medications that are known to affect smoking cessation (e.g. clonidine);
• Smokeless tobacco (chewing tobacco, snuff), pipes or e-cigarettes;
• Wellbutrin, bupropion, Zyban, Chantix, nicotine replacement therapy or any other smoking cessation aid.
• Use of opiate medications for pain or sleep (non-opiate medication for pain or sleep will be allowed) within the past 14 days;
• Smokes more than one cigar a month.
• Alcohol abuse;
• Significant adverse reaction to nicotine patches, in the past.
• Known hypersensitivity to moclobemide or other MAO-A inhibitors.
• Current participation or recent participation (in the past 30 days) in another smoking study at our center or another research facility.
• Current participation or recent participation (in the past six months) in another medical research study.