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

Trial end date:
Target enrollment:
Participant gender:
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.
Phase 2
Accepts Healthy Volunteers?
Lead Sponsor:
Jed E. Rose
National Institute on Drug Abuse (NIDA)
Philip Morris USA, Inc.
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

- 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;

- 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

- 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.