Innovative Interventions for Smoking Cessation

This study has been completed.
Sponsor:
Collaborator:
Information provided by (Responsible Party):
University of Minnesota - Clinical and Translational Science Institute
ClinicalTrials.gov Identifier:
NCT01050569
First received: January 14, 2010
Last updated: January 14, 2014
Last verified: January 2014

January 14, 2010
January 14, 2014
October 2008
December 2011   (final data collection date for primary outcome measure)
  • End of Treatment Abstinence Rate [ Time Frame: 12 week ] [ Designated as safety issue: No ]
    Cotinine and carbon monoxide (CO) verified point prevalence abstinence
  • End of Follow-up Abstinence Rates [ Time Frame: 36 weeks ] [ Designated as safety issue: No ]
    CO- and cotinine-verified point prevalence abstinence
  • End of treatment abstinence rate [ Time Frame: 6 week ] [ Designated as safety issue: No ]
  • End of follow-up abstinence rates [ Time Frame: 26 weeks ] [ Designated as safety issue: No ]
Complete list of historical versions of study NCT01050569 on ClinicalTrials.gov Archive Site
  • Exposure to Tobacco Toxicants [ Time Frame: 6 weeks ] [ Designated as safety issue: Yes ]
  • Time to Lapse or Relapse to Tobacco Use [ Time Frame: 26 weeks ] [ Designated as safety issue: No ]
  • Time to lapse or relapse to tobacco use [ Time Frame: 26 weeks ] [ Designated as safety issue: No ]
  • Effect on nicotine withdrawal [ Time Frame: 8 weeks ] [ Designated as safety issue: Yes ]
  • Exposure to tobacco toxicants [ Time Frame: 6 weeks ] [ Designated as safety issue: Yes ]
  • Exploratory predictors of cessation and relapse [ Time Frame: 26 weeks ] [ Designated as safety issue: No ]
Not Provided
Not Provided
 
Innovative Interventions for Smoking Cessation
Innovative Interventions for Smoking Cessation: Comparison of Very Low Nicotine Content Cigarettes Plus Nicotine Patch; Very Low Nicotine Content Cigarettes Alone or Nicotine Patch Alone

The purpose of this study is to evaluate the effect of a combination of the 21 mg nicotine patch and very low nicotine content (VLNC) cigarettes compared to 21 mg nicotine patch only and very low nicotine content cigarette only on abstinence, time to relapse and toxicant levels. The study will determine if adding nicotine replacement medication to the very low content cigarettes (VLNC) will augment treatment compared to nicotine patch only or to very low nicotine content cigarettes only.

The purpose of this study is to evaluate the effect of a combination of the 21 mg nicotine patch and very low nicotine content cigarette (VLNC) compared to the VLNC cigarette alone or 21 mg nicotine patch alone on abstinence, time to relapse and toxicant levels.

The following primary hypothesis will be tested:

Abstinence rates will be highest and the time to relapse will be the longest in the VLNC cigarettes plus nicotine patch condition compared to nicotine patch or VLNC cigarettes alone.

Other hypotheses include:

  1. Greater positive subjective responses to cigarettes will be observed with VLNC cigarettes plus patch vs. VLNC cigarette;
  2. Less drop-outs will be observed in the VLNC plus patch vs the other two conditions; and
  3. Less compensatory smoking will be observed in the VLNC plus patch condition compared to VLNC cigarette alone condition.

Cigarette smokers will be randomized to:

  1. VLNC cigarettes (which provide sensory behavioral aspects of smoking but with limited nicotine) plus nicotine patch for 6 weeks;
  2. Nicotine patch for 6 weeks; or
  3. VLNC cigarettes alone.

Outcome measures will include cessation assessed at the end of treatment as the primary endpoint and at 36 weeks post-treatment, time to lapse and relapse to usual brand cigarettes, and biomarkers of toxicant exposure. Predictors of abstinence and treatment response for each of the treatment conditions will be explored.

Interventional
Phase 2
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Factorial Assignment
Masking: Open Label
Primary Purpose: Treatment
Tobacco Use Disorder
  • Drug: Nicotine Patch
    21 mg
    Other Name: Nicoderm CQ
  • Other: VLNC Cigarette
    Cigarette where the tobacco contains <0.1 mg of nicotine yield.
    Other Names:
    • Quest 3
    • Xodus
  • Other: VLNC Cigarette Plus Nicotine Patch
    21 mg nicotine patch plus use of cigarette with tobacco containing <0.1 mg nicotine yield.
    Other Names:
    • Nicoderm CQ
    • Quest 3
    • Xodus
  • Active Comparator: VLNC Cigarette
    Very Low Nicotine Content Cigarette. Dosage: 0.05 mg to 0.09 mg nicotine yield cigarette; Frequency: Daily; Duration: 6 weeks.
    Intervention: Other: VLNC Cigarette
  • Active Comparator: Nicotine Patch
    21 mg nicotine patch. Dosage: 21 mg; Frequency: Daily; Duration: 6 weeks.
    Intervention: Drug: Nicotine Patch
  • Experimental: VLNC Cigarette plus Nicotine Patch
    Very Low Nicotine Content Cigarette plus 21 mg Nicotine Patch. Patch Dosage: 21 mg; Cigarette Dosasge: 0.05 to 0.09 mg nicotine yield; Frequency: Daily; Duration: 6 weeks
    Intervention: Other: VLNC Cigarette Plus Nicotine Patch
Hatsukami DK, Hertsgaard LA, Vogel RI, Jensen JA, Murphy SE, Hecht SS, Carmella SG, al'Absi M, Joseph AM, Allen SS. Reduced nicotine content cigarettes and nicotine patch. Cancer Epidemiol Biomarkers Prev. 2013 Jun;22(6):1015-24. doi: 10.1158/1055-9965.EPI-12-1439. Epub 2013 Apr 19.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
235
June 2012
December 2011   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • a) Smoking at least 10 cigarettes daily for the past year;
  • b) In good physical health;
  • c) No contraindications for medicinal nicotine; and
  • d) Stable, good mental health.

Exclusion Criteria:

  • a) Subjects must not be using other tobacco or nicotine products.
  • b) Female subjects cannot be pregnant or nursing and must be using appropriate birth control.
Both
18 Years and older
Yes
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT01050569
1R01DA025598, R01DA025598, DPMC
Yes
University of Minnesota - Clinical and Translational Science Institute
University of Minnesota - Clinical and Translational Science Institute
National Institute on Drug Abuse (NIDA)
Principal Investigator: Dorothy Hatsukami, PhD University of Minnesota - Clinical and Translational Science Institute
University of Minnesota - Clinical and Translational Science Institute
January 2014

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