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

Tracking Information

• First Submitted Date: February 24, 2006
• First Posted Date: February 28, 2006
• Results First Submitted Date: May 31, 2012
• Results First Posted Date: September 5, 2012
• Last Update Posted Date: September 20, 2013
• Study Start Date: January 2006
• Actual Primary Completion Date: February 2008 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures (submitted: August 2, 2012)

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

• Original Primary Outcome Measures: Not Provided
• Current Secondary Outcome Measures: Not Provided
• Original Secondary Outcome Measures: Not Provided
• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• Brief Title: Gradual vs. Abrupt Cessation Treatment for Smoking
• Official Title: Gradual vs. Abrupt Cessation Treatment for Smoking
• 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.
• 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 Type: Interventional
• Study Phase: Phase 2
• Study Design: Allocation: Randomized; Intervention Model: Parallel Assignment; Masking: None (Open Label); Primary Purpose: Treatment
• Condition: 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.
• 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

Study Arms

• 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

• Publications *: 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.

Recruitment Information

• Recruitment Status: Completed
• Actual Enrollment (submitted: February 24, 2006): 750
• Original Enrollment: Same as current
• Actual Study Completion Date: February 2008
• Actual Primary Completion Date: February 2008 (Final data collection date for primary outcome measure)

Eligibility 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

Sex/Gender

• Sexes Eligible for Study: All

• Ages: 18 Years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Contacts: Contact information is only displayed when the study is recruiting subjects
• Listed Location Countries: United States

Administrative Information

• NCT Number: NCT00297492
• Other Study ID Numbers: R01DA011557-07( U.S. NIH Grant/Contract ); R01DA011557-07 ( U.S. NIH Grant/Contract )
• Has Data Monitoring Committee: No
• U.S. FDA-regulated Product: Not Provided
• IPD Sharing Statement: Not Provided
• Current Responsible Party: John Hughes, University of Vermont
• Original Responsible Party: Not Provided
• Current Study Sponsor: University of Vermont
• Original Study Sponsor: National Institute on Drug Abuse (NIDA)
• Collaborators: National Institute on Drug Abuse (NIDA)

Investigators

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

• PRS Account: University of Vermont
• Verification Date: September 2013