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Gradual vs. Abrupt Cessation Treatment for Smoking

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00297492
First Posted: February 28, 2006
Last Update Posted: September 20, 2013
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborator:
National Institute on Drug Abuse (NIDA)
Information provided by (Responsible Party):
John Hughes, University of Vermont
  Purpose
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 Intervention 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

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Gradual vs. Abrupt Cessation Treatment for Smoking

Resource links provided by NLM:


Further study details as provided by John Hughes, University of Vermont:

Primary Outcome Measures:
  • 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


Enrollment: 750
Study Start Date: January 2006
Study Completion Date: February 2008
Primary Completion Date: February 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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.
  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00297492


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:
Responsible Party: John Hughes, Professor of Psychiatry, University of Vermont
ClinicalTrials.gov Identifier: NCT00297492     History of Changes
Other Study ID Numbers: R01DA011557-07 ( U.S. NIH Grant/Contract )
First Submitted: February 24, 2006
First Posted: February 28, 2006
Results First Submitted: May 31, 2012
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