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

The proposed study will assess the efficacy of moclobemide, a selective, reversible MAO-A inhibitor, in facilitating smoking cessation in treatment-seeking female smokers. This rationale is based on several findings from previous work: 1) cigarette smoke contains constituents that inhibit both forms of the enzyme monoamine oxidase (MAO-A and MAO-B); 2) that severity of depression symptoms after smoking abstinence is correlated with the level of MAO-A inhibition previously obtained from smoking; 3) moclobemide, an MAO-A inhibitor was found efficacious in a smoking cessation treatment trial (Berlin et al., 1995); and 4) women show a greater association between smoking and depression than men and women smokers in our previous trials report smoking to alleviate symptoms of depression to a greater extent than men.


Eligibility Criteria:
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.