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Completed

NCT Number: NCT00297492

Gradual vs. Abrupt Cessation Treatment for Smoking

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.

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Key information

Conditions

Smoking Cessation Behavior Health Behavior

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

University of Vermont Human Behavioral Pharmacology Lab

Burlington, Vermont, 05401, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

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

Treatment and study plan

Reduction Phone Counseling

Behavioral

Counseling of smokers to undergo gradual reduction in cigarettes per day prior to quit date. This includes 5 counseling calls: 3 calls focused on reduction prior to the quit date, 1 call two days prior to the quit date to discuss common strategies for preparing to quit, and 1 call two days after the quit date to discuss relapse prevention. Telephone counseling also discusses the proper use of nicotine lozenges during reduction and after the quit date.

Abrupt Phone Counseling

Behavioral

Counseling of smokers to set a quit date and not change cigarettes per day prior to quit date. This includes 5 counseling calls: 1 to set a quit date, 1 two days prior to the quit date to discuss common strategies for preparing to quit, and 3 after the quit date to discuss relapse prevention. Telephone counseling also discusses the proper use of nicotine lozenges after the quit date.

Minimal Abrupt Phone Counseling

Behavioral

Minimal counseling to mimic intervention at a primary care office. This includes 2 counseling calls: 1 to set a quit date and 1 two days after the quit date to discuss relapse prevention. Telephone counseling also discusses the proper use of nicotine lozenges after the quit date.

Pre-Quit Nicotine Lozenges

Drug

2 mg lozenges for participants usually smoke their first cigarette more than 30 minutes after awaking.

4 mg lozenge for participants who usually smoke their first cigarette less than 30 minutes after awaking.

Replace each forgone cigarette during reduction with one lozenge. Use additional lozenges to combat cravings to smoke.

Other names: Commit Nicotine Lozenges

Post-Quit Nicotine Lozenges

Drug

2 mg lozenges for participants usually smoke their first cigarette more than 30 minutes after awaking.

4 mg lozenge for participants who usually smoke their first cigarette less than 30 minutes after awaking.

Replace each forgone cigarette while abstinent with one lozenge. Use additional lozenges to combat cravings to smoke.

Other names: Commit Nicotine Lozenges

Primary outcomes

  1. Number of Participants With Prolonged Abstinence Through 6 Months Verified by Carbon Monoxide Measurement

    Time frame: 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

Sponsors and collaborators

Lead sponsor

University of Vermont

Other

Collaborators

  • National Institute on Drug Abuse (NIDA)

Registry information

Important dates

Study start
2006
Primary completion
2008
Study completion
2008
First posted
Feb 28, 2006
Registry last updated
Sep 20, 2013

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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