Conditions: Tobacco Use Disorder
Keywords: Smoking Cessation Nicotine Free Cigarettes
Allocation: RANDOMIZED | Intervention model: FACTORIAL
Enrollment: 235
Healthy volunteers: yes

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.

Arms:
arm 1: Very Low Nicotine Content Cigarette. Dosage: 0.05 mg to 0.09 mg nicotine yield cigarette; Frequency: Daily; Duration: 6 weeks. arm 2: 21 mg nicotine patch. Dosage: 21 mg; Frequency: Daily; Duration: 6 weeks. arm 3: 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

Interventions: intervention 1: Nicotine Patch intervention 2: VLNC Cigarette intervention 3: VLNC Cigarette Plus Nicotine Patch
Intervention descriptions: intervention 1: 21 mg intervention 2: Cigarette where the tobacco contains \<0.1 mg of nicotine yield. intervention 3: 21 mg nicotine patch plus use of cigarette with tobacco containing \<0.1 mg nicotine yield.

Protocol document: