Innovative Interventions for Smoking Cessation

Study Overview
=================
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: 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.

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

Conditions
-----------------
Tobacco Use Disorder

Intervention / Treatment
-----------------
* Drug: Nicotine Patch
* Other: VLNC Cigarette
* Other: VLNC Cigarette Plus Nicotine Patch


Participation Criteria
=================
Eligibility Criteria
-----------------
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.

Ages Eligible for Study
-----------------
Minimum Age: 18 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
Accepts Healthy Volunteers

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Factorial Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: VLNC Cigarette<br>Very Low Nicotine Content Cigarette. Dosage: 0.05 mg to 0.09 mg nicotine yield cigarette; Frequency: Daily; Duration: 6 weeks. | Other: VLNC Cigarette<br>* Cigarette where the tobacco contains <0.1 mg of nicotine yield.<br>* Other names: Xodus;|
| Active Comparator: Nicotine Patch<br>21 mg nicotine patch. Dosage: 21 mg; Frequency: Daily; Duration: 6 weeks. | Drug: Nicotine Patch<br>* 21 mg<br>* Other names: Nicoderm CQ;|
| Experimental: VLNC Cigarette plus Nicotine Patch<br>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<br>* 21 mg nicotine patch plus use of cigarette with tobacco containing <0.1 mg nicotine yield.<br>* Other names: Xodus;|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| End of Treatment Abstinence Rate | Cotinine and carbon monoxide (CO) verified point prevalence abstinence | 12 week | 
| End of Follow-up Abstinence Rates | CO- and cotinine-verified point prevalence abstinence | 36 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Exposure to Tobacco Toxicants |  | 6 weeks | 
| Time to Lapse or Relapse to Tobacco Use |  | 26 weeks | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Smoking Cessation, Nicotine Free Cigarettes