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Treatment to Quit Smoking

This study has been completed.

Sponsored by: Department of Veterans Affairs
Information provided by: Department of Veterans Affairs
ClinicalTrials.gov Identifier: NCT00018161
  Purpose

This protocol evaluates the efficacy of combining pharmacologic treatments for smoking cessation, entailing the use of the nicotine skin patch with the nicotinic antagonist mecamylamine, with a specific behavioral therapy designed to inhibit the smoking urge.


Condition Intervention Phase
Smoking
Drug: Mecamylamine
Drug: Nicotine Patch
Behavioral: Cigarette brand switching
Phase II

MedlinePlus related topics:   Smoking    Smoking Cessation   

ChemIDplus related topics:   Nicotine polacrilex    Nicotine tartrate    Mecamylamine    Mecamylamine hydrochloride   

U.S. FDA Resources

Study Type:   Interventional
Study Design:   Treatment, Randomized, Double-Blind, Active Control, Parallel Assignment, Efficacy Study
Official Title:   Combined Pharmacologic/Behavioral Treatment for Smoking Cessation

Further study details as provided by Department of Veterans Affairs:

Study Start Date:   January 1997
Estimated Study Completion Date:   June 2001

Detailed Description:

Previous studies have found that nicotine/mecamylamine treatment more than doubles the long-term abstinence rates relative to nicotine replacement alone. Recent evidence supports the hypothesis that nicotine/mecamylamine treatment prior to smoking cessation partially blocks the rewarding effects of cigarette smoking and hence promotes extinction of the smoking habit, facilitating subsequent abstinence. The behavioral approach employed is also an extinction strategy and involves having smokers switch to de-nicotinized tobacco cigarettes for two weeks prior to quitting smoking. It is hypothesized that the use of de-nicotinized cigarettes might provide more complete extinction than provided by the partial pharmacologic blockade using nicotine/mecamylamine alone. The pharmacologic treatment was expected to increase compliance with the de-nicotinized cigarette smoking regimen, because subjects' usual brands of cigarettes will be less appealing than in the absence of nicotine/mecamylamine treatment. Together the brand-switching and nicotine/mecamylamine therapies were expected to reduce cravings and other withdrawal symptoms as well as increase long-term abstinence from smoking.

  Eligibility
Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No

Criteria
  • Smokers,
  • Ages 18-65, wanted to quit smoking.
  • Must be in good health
  • Exclude cardiac disease, hypotensive or hypertensive, skin allergy, glaucoma, prostatic hypertrophy, pregnant women, drug or alcohol abuse, kidney disease.
  Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00018161

Locations
United States, North Carolina
Veterans Affairs Medical Center    
      Durham, North Carolina, United States, 27705

Sponsors and Collaborators

Investigators
Investigator:     Eric C Westman, M.D.    
  More Information

Study ID Numbers:   ADRD-008-97F
First Received:   July 3, 2001
Last Updated:   September 4, 2007
ClinicalTrials.gov Identifier:   NCT00018161
Health Authority:   United States: Federal Government

Keywords provided by Department of Veterans Affairs:
Nicotine  
addiction  
cigarette smoking  

Study placed in the following topic categories:
Nicotine polacrilex
Smoking
Behavior, Addictive
Nicotine
Mecamylamine

Additional relevant MeSH terms:
Ganglionic Blockers
Neurotransmitter Agents
Cholinergic Agonists
Molecular Mechanisms of Pharmacological Action
Cholinergic Antagonists
Nicotinic Agonists
Nicotinic Antagonists
Physiological Effects of Drugs
Cardiovascular Agents
Antihypertensive Agents
Cholinergic Agents
Pharmacologic Actions
Habits
Autonomic Agents
Therapeutic Uses
Ganglionic Stimulants
Peripheral Nervous System Agents

ClinicalTrials.gov processed this record on August 21, 2008




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