Naltrexone Augmentation of Nicotine Patch Therapy - 1
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government.
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This double blind placebo controlled study is designed to determine whether naltrexone can be used to help reduce cigarette use and craving for cigarettes. Eligible participants will receive 21mg transdermal nicotine as an outpatient. In addition, participants will receive one of three doses of naltrexone (25,50 or 100mg) or a placebo and brief counseling over the course of six weeks with follow-up appointments three, six, and twelve months after the beginning of treatment.
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Ages Eligible for Study:
18 Years to 99 Years (Adult, Senior)
Sexes Eligible for Study:
Accepts Healthy Volunteers:
Age 18 and older
Willingness and ability to give written consent
Smoking 20 cigarettes per day for at least 1 year
At least one prior attempt to stop smoking
Baseline expired carbon-monoxide level of at least 10 ppm
Weigh at least 100 lbs.
One person per household
Pregnant or nursing women or women who do not use a reliable form of birth control
Unstable cardiac disease
History of dermatoses
Current alcohol dependence
Current use of opiates
A urine drug screen that is positive for opiates
Serious current neurologic, psychiatric or medical illness