Treatment to Quit Smoking

Combined Pharmacologic/Behavioral Treatment for Smoking Cessation

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.

Study Overview

• Status: Completed
• Conditions: Smoking
• Intervention / Treatment: Drug: Mecamylamine; Drug: Nicotine Patch; Behavioral: Cigarette brand switching

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
• Phase: Phase 2

Contacts and Locations

Study Locations

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

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 14 years to 61 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

• 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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Collaborators and Investigators

• Sponsor: US Department of Veterans Affairs
• Investigators: Eric C Westman, M.D.

Study record dates

Study Major Dates

• Study Start: January 1, 1997
• Study Completion: June 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: addiction; Nicotine; cigarette smoking
• Additional Relevant MeSH Terms: Physiological Effects of Drugs; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; Antihypertensive Agents; Autonomic Agents; Peripheral Nervous System Agents; Cholinergic Antagonists; Cholinergic Agents; Ganglionic Stimulants; Nicotinic Agonists; Cholinergic Agonists; Ganglionic Blockers; Nicotinic Antagonists; Nicotine; Mecamylamine
• Other Study ID Numbers: ADRD-008-97F