Treatment to Quit Smoking

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. Read our disclaimer for details. Identifier: NCT00018161
Recruitment Status : Completed
First Posted : July 5, 2001
Last Update Posted : January 21, 2009
Information provided by:
VA Office of Research and Development

Brief Summary:
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 or disease Intervention/treatment Phase
Smoking Drug: Mecamylamine Drug: Nicotine Patch Behavioral: Cigarette brand switching Phase 2

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.

Study Type : Interventional  (Clinical Trial)
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double
Primary Purpose: Treatment
Official Title: Combined Pharmacologic/Behavioral Treatment for Smoking Cessation
Study Start Date : January 1997
Study Completion Date : June 2001

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Smoking

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
  • 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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00018161

United States, North Carolina
Veterans Affairs Medical Center
Durham, North Carolina, United States, 27705
Sponsors and Collaborators
VA Office of Research and Development
OverallOfficial: Eric C Westman, M.D. Identifier: NCT00018161     History of Changes
Other Study ID Numbers: ADRD-008-97F
First Posted: July 5, 2001    Key Record Dates
Last Update Posted: January 21, 2009
Last Verified: September 2007

Keywords provided by VA Office of Research and Development:
cigarette smoking

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