Clinical Trial 21052

Durham, NC 27695


Summary:

The purpose of this study is to assess the efficacy of moclobemide, a selective, reversible MAO-A inhibitor, in facilitating smoking cessation in treatment-seeking female smokers..

This study consists of a physical screening session (scheduled between 8:00 am and 2:30 pm Monday through Friday) and seven study visits over a 12-week period. You may also be asked to come in for a follow-up visit six months after your quit day.

The physical screening visit will take approximately 2 to 2 ½ hours, and includes a physical exam and a drug screening test. If you test positive for illegal drugs, you will not be eligible to participate.

If the screening results confirm that you are a good match for this study, you will schedule an appointment for your first study visit approximately one week later. You will wear nicotine patches for one week, and at your second study visit, you will be given Moclobomide tablets in addition to wearing a nicotine patch. At each study visit you will be given enough of the study drugs to last until your next visit.

The first study session will last approximately 1 to 1½ hours, and all other study visits will last approximately 45 minutes to 1 hour. All of the seven study visits will take place between 12PM and 4PM Monday through Friday. If you complete all study visits and requirements you will be compensated for your time. You will not be compensated for the physical screening visit. You will receive a check in the mail after you complete study participation. Please allow four to six weeks for your payment to be processed. If you qualify for and attend the follow-up study visit six months after your quit day you will receive additional compensation.

This study is recruiting in Durham, Raleigh, Winston-Salem and Charlotte.


Qualified Participants Must:

Inclusion Criteria

• Have no known serious medical conditions
• Be Female
• Be between 18 and 65 years of age
• Smoke an average of at least 20 cigarettes per day
• Have smoked at least one cumulative year
• Have an expired air CO reading of at least 10ppm
• Be 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
• use of opiate medications


Qualified Participants May Receive:

Compensation for their time.


Clinical trials are medical research studies designed to test the safety and/or effectiveness of new investigational drugs, devices, or treatments in humans. These studies are conducted worldwide for a range of conditions and illnesses. Learn more about clinical research and participating in a study at About Clinical Trials.