Gradual vs. Abrupt Cessation Treatment for Smoking

Smoking Cessation Clinical Trial

Official title:

Gradual vs. Abrupt Cessation Treatment for Smoking

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00297492
• Other study ID #: R01DA011557-07
• Secondary ID: R01DA011557-07
• Status: Completed
• Phase: Phase 2
• First received: February 24, 2006
• Last updated: September 17, 2013
• Start date: January 2006
• Est. completion date: February 2008

Study information

• Verified date: September 2013
• Source: University of Vermont
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Federal Government
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 750
• Est. completion date: February 2008
• Est. primary completion date: February 2008
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Smoking Cessation

Intervention

Behavioral:
• 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.

Drug:
• 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.

Locations

Country	Name	City	State
United States	University of Vermont Human Behavioral Pharmacology Lab	Burlington	Vermont

Sponsors (2)

Lead Sponsor	Collaborator
University of Vermont	National Institute on Drug Abuse (NIDA)

Country where clinical trial is conducted

United States, 

References & Publications (1)

Hughes JR, Solomon LJ, Livingston AE, Callas PW, Peters EN. A randomized, controlled trial of NRT-aided gradual vs. abrupt cessation in smokers actively trying to quit. Drug Alcohol Depend. 2010 Sep 1;111(1-2):105-13. doi: 10.1016/j.drugalcdep.2010.04.007 — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No