Varenicline OTC Trial on Efficacy and Safety

Given the recent research on varenicline showing that it is more effective than nicotine
patch and bupropion, and with the removal of the box warning, research is needed to assess
whether smokers can use varenicline without a prescription and formal behavioral support. To
test this, the primary goal of the proposed research is to test whether varenicline is a
candidate for switching from prescription (Rx) to OTC, and whether a dose lower than that
currently approved is as effective in an OTC environment. To understand the within-person
mechanisms explaining how and when OTC varenicline might improve cessation outcomes, the
investigators also propose to assess experience with OTC varenicline via (a) ecological
momentary assessment (EMA).

Primary Objectives:

1. To assess the safety and effectiveness of the current FDA-approved 1 mg b.i.d.
varenicline for smoking cessation in comparison with placebo when used in a simulated
OTC study condition.

2. To assess the safety and effectiveness of .5mg b.i.d. varenicline in comparison with 1mg
b.i.d. varenicline and placebo when used in a simulated OTC study condition.

Inclusion Criteria:

1. 21 years of age or older

2. Self-reported daily smoker

3. Breath Carbon monoxide > 10ppm

4. Motivated to quit smoking completely within five weeks of the Screening Visit (>5 on
reported motivation)

5. Capable of and agree to complete study requirements

6. Literate in English, self-report

7. Must be available for the duration of study

8. Informed consent obtained

9. Willing and able to provide additional data between visits using ecological momentary
assessment (EMA)

10. Must own study compatible smart-phone (iPhone or Android)

Exclusion Criteria:

1. Any self-report, diagnosis or treatment of heart attack, unstable angina, angioedema,
seizures, cerebrovascular accident (CVA) within the last six months.

2. Any self-report, diagnosis or treatment of bipolar, schizophrenia or suicidal ideation
within the last six months. (For suicidal ideation a score of ≥7 on the Suicidal
Behavior Questionnaire, see Appendix 15)

3. Self-report of diagnosis or treatment for depression within the past six months,
unless participant has written permission by their healthcare provider to participate

4. Systolic blood pressure 160 or higher and/or diastolic blood pressure 100 or higher

5. History of renal disease

6. Allergy to any of the ingredients in varenicline

7. Participation in another smoking cessation program or any type of clinical trial in
the past 3 months

8. Use of any smoking cessation medication in the past three months

9. Any other medical condition(s) which the licensed study physician deems unacceptable
for participation in this study

10. Positive drug screen indicating possible substance abuse (eg opiates, amphetamines,
benzodiazepines, cocaine or other substances), unless participant can show that the
medication has been prescribed by licensed clinical provider.

11. Consume greater than 21 alcohol drinks per week.

12. No two members of the same household may participate in this study

13. No study staff or their immediate family may participate in the study

14. Females who are pregnant, breast feeding, or not currently using a medically approved
form of birth control and unwilling to do so.

Acceptable methods of birth control include abstinence, oral contraceptives, the
contraceptive patch, the contraceptive ring, and condoms.