Naltrexone and Patch for Smokers

This study has been completed.
Sponsor:
Information provided by:
Department of Veterans Affairs
ClinicalTrials.gov Identifier:
NCT00018213
First received: July 3, 2001
Last updated: January 20, 2009
Last verified: September 2007
  Purpose

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.


Condition Intervention
Smoking
Drug: Naltrexone Hydrochloride
Drug: Transdermal Nicotine

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Double-Blind
Primary Purpose: Treatment
Official Title: Naltrexone and Nicotine Replacement Effects on Cue Reactivity of Smokers

Resource links provided by NLM:


Further study details as provided by Department of Veterans Affairs:

Study Start Date: April 1998
Estimated Study Completion Date: March 2001
  Eligibility

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
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

  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00018213

Locations
United States, Rhode Island
VA Medical Center
Providence, Rhode Island, United States, 02908
Sponsors and Collaborators
  More Information

No publications provided

ClinicalTrials.gov Identifier: NCT00018213     History of Changes
Other Study ID Numbers: ADRD-020-97F
Study First Received: July 3, 2001
Last Updated: January 20, 2009
Health Authority: United States: Federal Government

Keywords provided by Department of Veterans Affairs:
Naltrexone
Nicotine patch
Tobacco dependence

Additional relevant MeSH terms:
Smoking
Habits
Naltrexone
Nicotine polacrilex
Nicotine
Narcotic Antagonists
Physiological Effects of Drugs
Pharmacologic Actions
Sensory System Agents
Peripheral Nervous System Agents
Central Nervous System Agents
Therapeutic Uses
Ganglionic Stimulants
Autonomic Agents
Nicotinic Agonists
Cholinergic Agonists
Cholinergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Central Nervous System Stimulants

ClinicalTrials.gov processed this record on April 23, 2014