Study Results
Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.
View full resultsBasic Information
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COMPLETED
PHASE2
750 participants
INTERVENTIONAL
2006-01-31
2008-02-29
Brief Summary
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Detailed Description
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Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Gradual reduction
Intervention: Reduction Phone Counseling. Intervention: Pre-Quit Nicotine Lozenges. Intervention: Post-Quit Nicotine Lozenges.
Reduction Phone Counseling
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.
Pre-Quit Nicotine Lozenges
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.
Post-Quit Nicotine Lozenges
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.
Abrupt cessation
Intervention: Abrupt Phone Counseling. Intervention: Post-Quit Nicotine Lozenges.
Abrupt Phone Counseling
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.
Post-Quit Nicotine Lozenges
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.
Minimal intervention
Intervention: Minimal Abrupt Phone Counseling. Intervention: Post-Quit Nicotine Lozenges.
Minimal Abrupt Phone Counseling
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.
Post-Quit Nicotine Lozenges
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.
Interventions
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Reduction Phone Counseling
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
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
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
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.
Post-Quit Nicotine Lozenges
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 Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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
* 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
18 Years
ALL
Yes
Sponsors
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National Institute on Drug Abuse (NIDA)
NIH
University of Vermont
OTHER
Responsible Party
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John Hughes
Professor of Psychiatry
Principal Investigators
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John Hughes, MD
Role: PRINCIPAL_INVESTIGATOR
University of Vermont
Locations
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University of Vermont Human Behavioral Pharmacology Lab
Burlington, Vermont, United States
Countries
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References
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