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Naltrexone and Patch for Smokers

This study has been completed.
Study NCT00018213.   Last updated on September 4, 2007.   Information provided by Department of Veterans Affairs

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Descriptive Information Fields
Brief Title  Naltrexone and Patch for Smokers
Official Title  Naltrexone and Nicotine Replacement Effects on Cue Reactivity of Smokers
Brief Summary

The aim of this study is to investigate the effects of naltrexone, alone and combined with nicotine patch, on responses of smokers to smoking cues after 10 hours of tobacco deprivation. Smokers who are not seeking treatment will be assigned to one of six conditions: They will receive either 50 mg of naltrexone or a placebo pill, and also will wear a nicotine patch that has 0, 21, or 42 mg of nicotine during the tobacco deprivation period. Both the day before the medication and deprivation and at the end of 10 hours of deprivation all will be exposed to lit cigarette cues in the laboratory. Effects of the medications will be assessed on withdrawal measures, urge to smoke, psychophysiological measures, and the topography of smoking three test cigarettes. Studies such as these can help to identify potential interventions for tobacco cessation or withdrawal, and thereby could result in less suffering and mortality.

Detailed Description
Study Phase
Study Type  Interventional
Study Design  Treatment, Randomized, Double-Blind, Placebo Control, Single Group Assignment, Efficacy Study
Primary Outcome Measure 
Secondary Outcome Measure 
Condition  Smoking
Intervention  Drug: Naltrexone Hydrochloride
Drug: Transdermal Nicotine
MEDLINE PMIDs
Links
Recruitment Information Fields
Recruitment Status  Completed
Enrollment 
Start Date  April 1998
Completion Date March 2001
Eligibility Criteria 

Adults who have smoked at least 25 cigarettes per day for at least a year. They are not using any method to quit smoking and are not using naltrexone. Must weigh at least 100lbs with no medical contraindications for naltrexone or transdermal nicotine. No contraindicated medications, no recent opiate use or history

Gender Both
Ages 18 Years to 65 Years
Accepts Healthy Volunteers Yes
Contacts ††
Location Countries  United States
Administrative Information Fields
NCT ID  NCT00018213
Organization ID ADRD-020-97F
Secondary IDs ††
Study Sponsor  Department of Veterans Affairs
Collaborators ††
Investigators 
Information Provided By Department of Veterans Affairs
Verification Date September 2007
First Received Date  July 3, 2001
Last Updated Date September 4, 2007

 †    Required WHO trial registration data element.
††   WHO trial registration data element that is required only if it exists.




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