Clinical trial NCT00297492
Conditions: Smoking Cessation
Keywords: Smoking Cessation Tobacco
Sponsor: University of Vermont
Start date: 2006-01-01; Completion date: 2008-02-01
Enrollment: 750 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

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.

Arms: arm 1: Intervention: Reduction Phone Counseling. Intervention: Pre-Quit Nicotine Lozenges. Intervention: Post-Quit Nicotine Lozenges. arm 2: Intervention: Abrupt Phone Counseling. Intervention: Post-Quit Nicotine Lozenges. arm 3: Intervention: Minimal Abrupt Phone Counseling. Intervention: Post-Quit Nicotine Lozenges.
Interventions: intervention 1: Reduction Phone Counseling intervention 2: Abrupt Phone Counseling intervention 3: Minimal Abrupt Phone Counseling intervention 4: Pre-Quit Nicotine Lozenges intervention 5: Post-Quit Nicotine Lozenges
Intervention descriptions: intervention 1: 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. intervention 2: 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. intervention 3: 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. intervention 4: 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. intervention 5: 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.

Protocol documents: