- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00018213
Naltrexone and Patch for Smokers
January 20, 2009 updated by: US Department of Veterans Affairs
Naltrexone and Nicotine Replacement Effects on Cue Reactivity of Smokers
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.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Interventional
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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Rhode Island
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Providence, Rhode Island, United States, 02908
- Va Medical Center
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
16 years to 63 years (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Single Group Assignment
- Masking: Double
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
April 1, 1998
Study Completion
March 1, 2001
Study Registration Dates
First Submitted
July 3, 2001
First Submitted That Met QC Criteria
July 4, 2001
First Posted (Estimate)
July 5, 2001
Study Record Updates
Last Update Posted (Estimate)
January 21, 2009
Last Update Submitted That Met QC Criteria
January 20, 2009
Last Verified
September 1, 2007
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
- Physiological Effects of Drugs
- Neurotransmitter Agents
- Molecular Mechanisms of Pharmacological Action
- Autonomic Agents
- Peripheral Nervous System Agents
- Cholinergic Agents
- Sensory System Agents
- Narcotic Antagonists
- Ganglionic Stimulants
- Nicotinic Agonists
- Cholinergic Agonists
- Alcohol Deterrents
- Nicotine
- Naltrexone
Other Study ID Numbers
- ADRD-020-97F
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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