Gradual vs. Abrupt Cessation Treatment for Smoking

Phase 2

Completed

• Conditions: Smoking Cessation
• Interventions: Behavioral: Abrupt Phone Counseling; Behavioral: Minimal Abrupt Phone Counseling; Behavioral: Reduction Phone Counseling; Drug: Pre-Quit Nicotine Lozenges; Drug: Post-Quit Nicotine Lozenges

• Registration Number: NCT00297492
• Lead Sponsor: University of Vermont

Brief Summary

This study tests whether stopping smoking by gradually cutting down first is more or less successful than stopping abruptly. We hypothesize that stopping by gradually cutting down first will produce more abstinence than stopping abruptly.

Detailed Description

For cigarette smokers who intend to stop smoking, most treatment guidelines recommend abrupt cessation. There is evidence from some small studies that gradually reducing the number of cigarettes per day smoked may increase success in quitting. In this study, we will randomize smokers who want to quit smoking in the next 30 days to one of three groups: gradual reduction, abrupt cessation, and minimal intervention.

Study Timeline

• Study Start: 2006-01
• Study First Submitted: 2006-02-24
• Study First Submitted QC: 2006-02-24
• Study First Posted: 2006-02-28
• Primary Completion: 2008-02
• Study Completion: 2008-02
• Results First Submitted: 2012-05-31
• Results First Submitted QC: 2012-08-02
• Results First Posted: 2012-09-05
• Status Verified: 2013-09
• Last Update Submitted: 2013-09-17
• Last Update Posted: 2013-09-20

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 750

Inclusion Criteria

• Interested in quitting gradually
• At least 18 years old
• Daily cigarette smoker
• Smoke at least 15 cigarettes per day (CPD)
• No change greater than 20% in CPD in the last month
• Interested in quitting in next 30 days
• Must agree to not use non-cigarette tobacco during study
• No use of smoking cessation medication in last month
• Have phone with voice mail
• Willing to use nicotine lozenge
• No other person in household in study
• Fluent/literate in English

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Exclusion Criteria

• Women who are pregnant or breastfeeding
• Currently using medication for depression or asthma
• Heart disease requiring medication
• Heart attack in last month
• Irregular heartbeat
• High blood pressure not controlled by medication
• Stomach ulcers
• Diabetes

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Gradual reduction	Post-Quit Nicotine Lozenges	Intervention: Reduction Phone Counseling. Intervention: Pre-Quit Nicotine Lozenges. Intervention: Post-Quit Nicotine Lozenges.
Abrupt cessation	Abrupt Phone Counseling	Intervention: Abrupt Phone Counseling. Intervention: Post-Quit Nicotine Lozenges.
Abrupt cessation	Post-Quit Nicotine Lozenges	Intervention: Abrupt Phone Counseling. Intervention: Post-Quit Nicotine Lozenges.
Minimal intervention	Minimal Abrupt Phone Counseling	Intervention: Minimal Abrupt Phone Counseling. Intervention: Post-Quit Nicotine Lozenges.
Minimal intervention	Post-Quit Nicotine Lozenges	Intervention: Minimal Abrupt Phone Counseling. Intervention: Post-Quit Nicotine Lozenges.
Gradual reduction	Reduction Phone Counseling	Intervention: Reduction Phone Counseling. Intervention: Pre-Quit Nicotine Lozenges. Intervention: Post-Quit Nicotine Lozenges.
Gradual reduction	Pre-Quit Nicotine Lozenges	Intervention: Reduction Phone Counseling. Intervention: Pre-Quit Nicotine Lozenges. Intervention: Post-Quit Nicotine Lozenges.

Primary Outcome Measures

Name	Time	Method
Number of Participants With Prolonged Abstinence Through 6 Months Verified by Carbon Monoxide Measurement	6 months	Number of participants with self-reported prolonged abstinence from cigarette smoking through 6 months of follow-up, verified by a breath carbon monoxide reading of less than 10 parts per million

Trial Locations

Locations (1)

University of Vermont Human Behavioral Pharmacology Lab; 🇺🇸 Burlington, Vermont, United States