Gradual vs. Abrupt Cessation Treatment for Smoking

University of Vermont

Status and phase: Completed; Phase 2

Conditions: Smoking Cessation

Treatments: Behavioral: Abrupt Phone Counseling; Drug: Post-Quit Nicotine Lozenges; Behavioral: Minimal Abrupt Phone Counseling; Drug: Pre-Quit Nicotine Lozenges; Behavioral: Reduction Phone Counseling

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT00297492

R01DA011557-07 (U.S. NIH Grant/Contract)

Details and patient eligibility

About

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.

Full 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.

Enrollment: 750 patients

Sex: All

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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750 participants in 3 patient groups

Gradual reduction

Experimental group

Description:

Intervention: Reduction Phone Counseling. Intervention: Pre-Quit Nicotine Lozenges. Intervention: Post-Quit Nicotine Lozenges.

Treatment:

Drug: Pre-Quit Nicotine Lozenges

Drug: Post-Quit Nicotine Lozenges

Behavioral: Reduction Phone Counseling

Abrupt cessation

Active Comparator group

Description:

Intervention: Abrupt Phone Counseling. Intervention: Post-Quit Nicotine Lozenges.

Treatment:

Behavioral: Abrupt Phone Counseling

Drug: Post-Quit Nicotine Lozenges

Minimal intervention

Active Comparator group

Description:

Intervention: Minimal Abrupt Phone Counseling. Intervention: Post-Quit Nicotine Lozenges.

Treatment:

Behavioral: Minimal Abrupt Phone Counseling

Drug: Post-Quit Nicotine Lozenges