Treatment to Quit Smoking

Smoking Clinical Trial

Official title:

Combined Pharmacologic/Behavioral Treatment for Smoking Cessation

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00018161
• Other study ID #: ADRD-008-97F
• Status: Completed
• Phase: Phase 2
• First received: July 3, 2001
• Last updated: January 20, 2009
• Start date: January 1997
• Est. completion date: June 2001

Study information

• Verified date: September 2007
• Source: VA Office of Research and Development
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Federal Government
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 0
• Est. completion date: June 2001
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 65 Years

Eligibility

• 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.

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double-Blind, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Smoking

Intervention

Drug:
• Mecamylamine

• Nicotine Patch

Behavioral:
• Cigarette brand switching

Locations

Country	Name	City	State
United States	Veterans Affairs Medical Center	Durham	North Carolina

Sponsors (1)

Lead Sponsor	Collaborator
VA Office of Research and Development

Country where clinical trial is conducted

United States,