ABOUT THIS STUDY
FOR MORE INFORMATION
Contact a representative by phone, email, or visiting the study website. Please see the references below:
Pfizer Clinical Trials Contact Center
602-827-2271
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)
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.
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Descriptive Information | |||||||
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Brief Title ICMJE | Varenicline OTC Trial on Efficacy and Safety | ||||||
Official Title ICMJE | Varenicline OTC Trial on Efficacy and Safety | ||||||
Brief Summary | The primary goal of the proposed research is to test whether varenicline (Chantix) is safe and effective as an over-the-counter (OTC) medication. | ||||||
Detailed Description | 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:
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Study Type ICMJE | Interventional | ||||||
Study Phase ICMJE | Phase 4 | ||||||
Study Design ICMJE | Allocation: Randomized Intervention Model: Parallel Assignment Masking: Triple (Participant, Care Provider, Investigator) Primary Purpose: Treatment | ||||||
Condition ICMJE |
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Intervention ICMJE |
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Study Arms ICMJE |
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Publications * | Not Provided | ||||||
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. | |||||||
Recruitment Information | |||||||
Recruitment Status ICMJE | Recruiting | ||||||
Estimated Enrollment ICMJE | 405 | ||||||
Original Estimated Enrollment ICMJE | Same as current | ||||||
Estimated Study Completion Date ICMJE | June 2022 | ||||||
Estimated Primary Completion Date | December 2021 (Final data collection date for primary outcome measure) | ||||||
Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
Acceptable methods of birth control include abstinence, oral contraceptives, the contraceptive patch, the contraceptive ring, and condoms. | ||||||
Sex/Gender ICMJE |
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Ages ICMJE | 21 Years and older (Adult, Older Adult) | ||||||
Accepts Healthy Volunteers ICMJE | Yes | ||||||
Contacts ICMJE |
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Listed Location Countries ICMJE | United States | ||||||
Removed Location Countries | |||||||
Administrative Information | |||||||
NCT Number ICMJE | NCT03557294 | ||||||
Other Study ID Numbers ICMJE | 1R01DA044125( U.S. NIH Grant/Contract ) R01DA044125 ( U.S. NIH Grant/Contract ) | ||||||
Has Data Monitoring Committee | No | ||||||
U.S. FDA-regulated Product |
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IPD Sharing Statement ICMJE |
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Responsible Party | Arizona State University | ||||||
Study Sponsor ICMJE | Arizona State University | ||||||
Collaborators ICMJE |
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Investigators ICMJE | Not Provided | ||||||
PRS Account | Arizona State University | ||||||
Verification Date | July 2020 | ||||||
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |