An Alternative Dosing Schedule of Varenicline for Smoking Cessation

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to explore the use of an prolonged alternative dosing schedule using varenicline for smoking cessation leading to greater quit rates and higher rates of continuous abstinence.

Detailed Description
-----------------
This pilot study will utilize a two group randomized design. Adult smokers who are motivated to quit smoking will be randomized to one of two treatment groups. Both groups will receive brief support counseling. During a one-week baseline and the 4-week pre-quit period smoking rate, smoking satisfaction, withdrawal, and craving will be assessed on a daily basis.

Official Title
-----------------
Extended Varenicline for Smoking Cessation: A Pilot Study

Conditions
-----------------
Smoking Cessation

Intervention / Treatment
-----------------
* Drug: varenicline
* Drug: placebo


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: currently smoking at least 15 cigarettes daily in good health able to read and speak English fluently have a home telephone and plan to reside in Western New York for 6 months willing to make quit attempt signed informed consent who planned quit attempt. Exclusion Criteria: serious medical condition depression or mental health condition requiring treatment in the past year history of panic disorder, psychosis, bipolar disorder alcohol or drug abuse in the past year use of tobacco products other than cigarettes current use of other cessation pharmacotherapies pregnancy/planned pregnancy.

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 65 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: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: varenicline<br>drug plus counseling. | Drug: varenicline<br>* variable dosing schedule<br>* Other names: Chantix;|
| Active Comparator: placebo<br>placebo plus counseling | Drug: placebo<br>* placebo<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in Smoking Behavior | Change in cigarettes per day from Week 2 to Week 5 | Change in cigarettes per day from Week 2 to Week 5 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Rates of Smoking Cessation. | To parallel most clinical trials of varenicline, we focused on CO-verified (<11 parts per million) continuous abstinence (not even one puff) during the final 4 weeks of treatment (i.e., post-quit weeks 8 through 11). Participants lost to follow-up were coded as smokers. | 12 weeks after quit date. | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
smoking cessation, varenicline, smoking cessation treatment