Gradual vs. Abrupt Cessation Treatment for Smoking

Study Overview
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Brief Summary
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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
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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.

Official Title
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Gradual vs. Abrupt Cessation Treatment for Smoking

Conditions
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Smoking Cessation

Intervention / Treatment
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* Behavioral: Reduction Phone Counseling
* Behavioral: Abrupt Phone Counseling
* Behavioral: Minimal Abrupt Phone Counseling
* Drug: Pre-Quit Nicotine Lozenges
* Drug: Post-Quit Nicotine Lozenges


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Gradual reduction<br>Intervention: Reduction Phone Counseling. Intervention: Pre-Quit Nicotine Lozenges. Intervention: Post-Quit Nicotine Lozenges. | Behavioral: Reduction Phone Counseling<br>* 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.<br>Drug: Pre-Quit Nicotine Lozenges<br>* 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.<br>* Other names: Commit Nicotine Lozenges;Drug: Post-Quit Nicotine Lozenges<br>* 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.<br>* Other names: Commit Nicotine Lozenges;|
| Active Comparator: Abrupt cessation<br>Intervention: Abrupt Phone Counseling. Intervention: Post-Quit Nicotine Lozenges. | Behavioral: Abrupt Phone Counseling<br>* 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.<br>Drug: Post-Quit Nicotine Lozenges<br>* 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.<br>* Other names: Commit Nicotine Lozenges;|
| Active Comparator: Minimal intervention<br>Intervention: Minimal Abrupt Phone Counseling. Intervention: Post-Quit Nicotine Lozenges. | Behavioral: Minimal Abrupt Phone Counseling<br>* 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.<br>Drug: Post-Quit Nicotine Lozenges<br>* 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.<br>* Other names: Commit Nicotine Lozenges;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of Participants With Prolonged Abstinence Through 6 Months Verified by Carbon Monoxide Measurement | 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 | 6 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Smoking Cessation, Tobacco