Innovative Interventions for Smoking Cessation
- Conditions
- Tobacco Use Disorder
- Interventions
- Registration Number
- NCT01050569
- Lead Sponsor
- University of Minnesota
- Brief Summary
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.
- Detailed Description
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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 235
- 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.
- 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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- FACTORIAL
- Arm && Interventions
Group Intervention Description VLNC Cigarette VLNC Cigarette Very Low Nicotine Content Cigarette. Dosage: 0.05 mg to 0.09 mg nicotine yield cigarette; Frequency: Daily; Duration: 6 weeks. Nicotine Patch Nicotine Patch 21 mg nicotine patch. Dosage: 21 mg; Frequency: Daily; Duration: 6 weeks. VLNC Cigarette plus Nicotine Patch 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
- Primary Outcome Measures
Name Time Method End of Treatment Abstinence Rate 12 week Cotinine and carbon monoxide (CO) verified point prevalence abstinence
End of Follow-up Abstinence Rates 36 weeks CO- and cotinine-verified point prevalence abstinence
- Secondary Outcome Measures
Name Time Method Exposure to Tobacco Toxicants 6 weeks Time to Lapse or Relapse to Tobacco Use 26 weeks
Trial Locations
- Locations (2)
University of MN's Tobacco Use Research Center
🇺🇸Minneapolis, Minnesota, United States
University of Minnesota
🇺🇸Duluth, Minnesota, United States