Gradual vs. Abrupt Cessation Treatment for Smoking

This study has been completed.
Sponsor:
Collaborator:
Information provided by (Responsible Party):
John Hughes, University of Vermont
ClinicalTrials.gov Identifier:
NCT00297492
First received: February 24, 2006
Last updated: September 17, 2013
Last verified: September 2013
  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
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: 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 University of Vermont:

Primary Outcome Measures:
  • Number of Participants With Prolonged Abstinence Through 6 Months Verified by Carbon Monoxide Measurement [ Time Frame: 6 months ] [ Designated as safety issue: No ]
    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

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00297492

Locations
United States, Vermont
University of Vermont Human Behavioral Pharmacology Lab
Burlington, Vermont, United States, 05401
Sponsors and Collaborators
University of Vermont
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: R01 DA11557-07, R01DA011557-07
Study First Received: February 24, 2006
Results First Received: May 31, 2012
Last Updated: September 17, 2013
Health Authority: United States: Federal Government

Keywords provided by University of Vermont:
Smoking Cessation
Tobacco

Additional relevant MeSH terms:
Nicotine
Autonomic Agents
Cholinergic Agents
Cholinergic Agonists
Ganglionic Stimulants
Molecular Mechanisms of Pharmacological Action
Neurotransmitter Agents
Nicotinic Agonists
Peripheral Nervous System Agents
Pharmacologic Actions
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on October 23, 2014