Gradual vs. Abrupt Cessation Treatment for Smoking

• ClinicalTrials.gov Identifier: NCT00297492
• Recruitment Status: Completed
• First Posted: February 28, 2006
• Results First Posted: September 5, 2012
• Last Update Posted: September 20, 2013
• Sponsor: University of Vermont
• Collaborator: National Institute on Drug Abuse (NIDA)
• Information provided by (Responsible Party): John Hughes, University of Vermont

Study Description

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.

Condition or disease	Intervention/treatment	Phase
Smoking Cessation	Behavioral: Reduction Phone Counseling; Behavioral: Abrupt Phone Counseling; Behavioral: Minimal Abrupt Phone Counseling; Drug: Pre-Quit Nicotine Lozenges; Drug: Post-Quit Nicotine Lozenges	Phase 2

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.

Study Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 750 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: Gradual vs. Abrupt Cessation Treatment for Smoking
• Study Start Date: January 2006
• Actual Primary Completion Date: February 2008
• Actual Study Completion Date: February 2008

Arms and Interventions

Arm	Intervention/treatment
Experimental: Gradual reduction; Intervention: Reduction Phone Counseling. Intervention: Pre-Quit Nicotine Lozenges. Intervention: Post-Quit Nicotine Lozenges.	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.; 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.; Other Name: Commit Nicotine Lozenges; Drug: 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 Name: Commit Nicotine Lozenges
Active Comparator: Abrupt cessation; Intervention: Abrupt Phone Counseling. Intervention: Post-Quit Nicotine Lozenges.	Behavioral: 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.; Drug: 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 Name: Commit Nicotine Lozenges
Active Comparator: Minimal intervention; Intervention: Minimal Abrupt Phone Counseling. Intervention: Post-Quit Nicotine Lozenges.	Behavioral: 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: 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 Name: Commit Nicotine Lozenges

Outcome Measures

Primary Outcome Measures :

1. Number of Participants With Prolonged Abstinence Through 6 Months Verified by Carbon Monoxide Measurement [ Time Frame: 6 months ]
   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

Eligibility Criteria

• Ages Eligible for Study: 18 Years and older (Adult, Older Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

Criteria

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

Contacts and Locations

Locations

United States, Vermont

University of Vermont Human Behavioral Pharmacology Lab

Burlington, Vermont, United States, 05401

Sponsors and Collaborators

University of Vermont

National Institute on Drug Abuse (NIDA)

Investigators

• Principal Investigator: John Hughes, MD; University of Vermont

More Information

Publications of Results:

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. Epub 2010 May 26.

• Responsible Party: John Hughes, Professor of Psychiatry, University of Vermont
• ClinicalTrials.gov Identifier: NCT00297492
• Other Study ID Numbers: R01DA011557-07 ( U.S. NIH Grant/Contract ); R01DA011557-07 ( U.S. NIH Grant/Contract )
• First Posted: February 28, 2006
• Results First Posted: September 5, 2012
• Last Update Posted: September 20, 2013
• Last Verified: September 2013

Keywords provided by John Hughes, University of Vermont:

Smoking Cessation; Tobacco

Additional relevant MeSH terms:

Nicotine; Ganglionic Stimulants; Autonomic Agents; Peripheral Nervous System Agents; Physiological Effects of Drugs; Nicotinic Agonists; Cholinergic Agonists; Cholinergic Agents; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action