Evaluation of Moclobemide, a Reversible MAO-A Inhibitor, as an Adjunct to Nicotine Replacement Therapy in Female Smokers
Trial end date:
SummaryThe 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.
Accepts Healthy Volunteers?No
Jed E. Rose
National Institute on Drug Abuse (NIDA)
Philip Morris USA, Inc.
- Have no known serious medical conditions;
- 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
- excessive alcohol consumption;
- use of other antidepressants;
- general anesthesia;
- participation in any other nicotine-related modification strategy outside of this
- 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;
- Tyramine rich foods;
- use of opiate medications.
- 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
- Current depression;
- Bulimia or anorexia;
- Use (within the past 45 days) of psychiatric medications including antidepressants and
- 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.