Innovative Interventions for Smoking Cessation
|Tobacco Use Disorder||Drug: Nicotine Patch Other: VLNC Cigarette Other: VLNC Cigarette Plus Nicotine Patch||Phase 2|
|Study Design:||Allocation: Randomized
Intervention Model: Factorial Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
|Official Title:||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|
- End of Treatment Abstinence Rate [ Time Frame: 12 week ]Cotinine and carbon monoxide (CO) verified point prevalence abstinence
- End of Follow-up Abstinence Rates [ Time Frame: 36 weeks ]CO- and cotinine-verified point prevalence abstinence
- Exposure to Tobacco Toxicants [ Time Frame: 6 weeks ]
- Time to Lapse or Relapse to Tobacco Use [ Time Frame: 26 weeks ]
|Study Start Date:||October 2008|
|Study Completion Date:||June 2012|
|Primary Completion Date:||December 2011 (Final data collection date for primary outcome measure)|
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.
Other: VLNC Cigarette
Cigarette where the tobacco contains <0.1 mg of nicotine yield.
Active Comparator: Nicotine Patch
21 mg nicotine patch. Dosage: 21 mg; Frequency: Daily; Duration: 6 weeks.
Drug: Nicotine Patch
Other Name: Nicoderm CQ
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
Other: VLNC Cigarette Plus Nicotine Patch
21 mg nicotine patch plus use of cigarette with tobacco containing <0.1 mg nicotine yield.
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:
- Greater positive subjective responses to cigarettes will be observed with VLNC cigarettes plus patch vs. VLNC cigarette;
- Less drop-outs will be observed in the VLNC plus patch vs the other two conditions; and
- Less compensatory smoking will be observed in the VLNC plus patch condition compared to VLNC cigarette alone condition.
Cigarette smokers will be randomized to:
- VLNC cigarettes (which provide sensory behavioral aspects of smoking but with limited nicotine) plus nicotine patch for 6 weeks;
- Nicotine patch for 6 weeks; or
- 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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01050569
|United States, Minnesota|
|University of Minnesota|
|Duluth, Minnesota, United States, 55812|
|University of MN's Tobacco Use Research Center|
|Minneapolis, Minnesota, United States, 55414|
|Principal Investigator:||Dorothy Hatsukami, PhD||University of Minnesota - Clinical and Translational Science Institute|