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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

February 24, 2006
September 17, 2013
January 2006
February 2008   (final data collection date for primary outcome measure)
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
Not Provided
Complete list of historical versions of study NCT00297492 on ClinicalTrials.gov Archive Site
Not Provided
Not Provided
Not Provided
Not Provided
 
Gradual vs. Abrupt Cessation Treatment for Smoking
Gradual vs. Abrupt Cessation Treatment for Smoking

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.

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.

Interventional
Phase 2
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Smoking Cessation
  • 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.
  • 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.
  • 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: 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
  • Experimental: Gradual reduction
    Intervention: Reduction Phone Counseling. Intervention: Pre-Quit Nicotine Lozenges. Intervention: Post-Quit Nicotine Lozenges.
    Interventions:
    • Behavioral: Reduction Phone Counseling
    • Drug: Pre-Quit Nicotine Lozenges
    • Drug: Post-Quit Nicotine Lozenges
  • Active Comparator: Abrupt cessation
    Intervention: Abrupt Phone Counseling. Intervention: Post-Quit Nicotine Lozenges.
    Interventions:
    • Behavioral: Abrupt Phone Counseling
    • Drug: Post-Quit Nicotine Lozenges
  • Active Comparator: Minimal intervention
    Intervention: Minimal Abrupt Phone Counseling. Intervention: Post-Quit Nicotine Lozenges.
    Interventions:
    • Behavioral: Minimal Abrupt Phone Counseling
    • Drug: Post-Quit Nicotine Lozenges
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.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
750
February 2008
February 2008   (final data collection date for primary outcome measure)

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
Both
18 Years and older
Yes
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00297492
R01 DA11557-07, R01DA011557-07
No
John Hughes, University of Vermont
University of Vermont
National Institute on Drug Abuse (NIDA)
Principal Investigator: John Hughes, MD University of Vermont
University of Vermont
September 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP