evaluation of moclobemide, a reversible mao-a inhibitor, as an adjunct to nicotine replacement therapy in female smokers

Conditions: Nicotine Dependence

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.

Keywords: nicotine addiction smoking cessation quit smoking moclobemide nicotine patch