Evaluation of Moclobemide, a Reversible MAO-A Inhibitor, as an Adjunct to Nicotine Replacement Therapy in Female Smokers
Condition: Nicotine Dependence
MeSH terms: Tobacco Use Disorder
Intervention: Nicotine Patch; Moclobemide
Intervention description: Pre-Quit Period: 2 weeks of patch use (21mg/24hr)
Post Quit Period: 10 weeks of patch use (21mg/24hr for 6 weeks, 14mg/24hr for 2 weeks, and 7mg/24hr for 2 weeks); Pre-Quit Period: 1 week of moclobemide use (400 mg/day in 2 divided doses)
Post Quit Period: 10 weeks of moclobemide use (400 mg/day in 2 divided doses)
Intervention MeSH terms: Moclobemide; Nicotine
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 76.0
Sex: Female
Minimum age: 18 Years
Maximum age: 65 Years
Healthy volunteers: No
Keywords: Nicotine addiction; Smoking Cessation; Quit Smoking; moclobemide; Nicotine Patch

Summary:

      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.