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

Completed · Phase 2

Conditions studied: Nicotine Dependence

In brief

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.

Key facts

Study ID

NCT01926626

Run by

Jed E. Rose

People needed

76

Starts

2013-09-01

Expected to finish

2014-10-01

Last updated by the study team

2017-08-23

Who can join

Age: 18 and older, up to 65. Sex: female. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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:

Where it is running

• Duke Center for Smoking Cessation — Charlotte, North Carolina, United States
• Duke Center forSmoking Cessation — Durham, North Carolina, United States
• Duke Center for Smoking Cessation — Winston-Salem, North Carolina, United States

Full record on ClinicalTrials.gov

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