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

This is an interventional treatment trial for Nicotine Dependence focused on measuring Nicotine addiction, Smoking Cessation, Quit Smoking, moclobemide, Nicotine Patch Read More

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.