Varenicline OTC Trial on Efficacy and Safety

NCT03557294

Last updated date
Study Location
Arizona State University
Phoenix, Arizona, 85004, United States
Contact
602-827-2271

FOR MORE INFORMATION

Contact a representative by phone, email, or visiting the study website. Please see the references below:

By phone

Pfizer Clinical Trials Contact Center

602-827-2271

By email

Contact

[email protected]

Call Now

Eligibility Criteria
condition
The disease, disorder, syndrome, illness, or injury that is being studied.
Tobacco Dependence, Withdrawal Symptoms, Smoking Cessation
Sex
Females and Males
Age
Pediatric Trials: 0-17 Years
Adult Trials: 18+ Years
21 + years
Inclusion Criteria
The factors, or reasons, that allow a person to participate in a clinical study.
Show details

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
The factors, or reasons, that prevent a person from participating in a clinical study.
Show details


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.

NEED INFO?

Questions about a trial? Call or email to reach a Pfizer Clinical Trial Contact Center Representative

Pfizer Clinical Trials Contact Center

1-800-718-1021

[email protected]

TRY A NEW SEARCH

Search for Clinical Trials by condition, keyword or trial number. Share your location or enter your city or zip code to find studies near you.

Based on your search, you may also be interested in

Tobacco Dependence, Withdrawal Symptoms, Smoking CessationVarenicline OTC Trial on Efficacy and Safety
NCT03557294
  1. Phoenix, Arizona
  2. Burbank, California
ALL GENDERS
21 Years+
years
MULTIPLE SITES
Advanced Information
Descriptive Information
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:

  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.
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
  • Tobacco Dependence
  • Withdrawal Symptoms
  • Smoking Cessation
Intervention  ICMJE
  • Drug: 1.0mg Varenicline b.i.d.
    Varenicline is classified as a selective nicotine receptor partial agonist (SNRPA) that works both to stimulate the nicotine receptor and block smoking reward at the ?4?2 nicotinic receptor subtype.
  • Drug: 0.5mg Varenicline b.i.d.
    Varenicline is classified as a selective nicotine receptor partial agonist (SNRPA) that works both to stimulate the nicotine receptor and block smoking reward at the ?4?2 nicotinic receptor subtype.
  • Drug: 0.0mg placebo Varenicline b.i.d.
    Product that looks like active varenicline, but contains no active ingredient
Study Arms  ICMJE
  • Experimental: 1.0mg varenicline b.i.d.
    Days 1 through 3: 0.5mg, once daily; days 4 through 7: 0.5mg, twice daily; days 8 through end of treatment: 1mg, twice daily.
    Intervention: Drug: 1.0mg Varenicline b.i.d.
  • Experimental: 0.5mg varenicline b.i.d.
    Days 1 through 3: 0.5mg, once daily; 0.5 mg b.i.d. dose starting at day 4 through the end of the study
    Intervention: Drug: 0.5mg Varenicline b.i.d.
  • Placebo Comparator: 0.0mg placebo varenicline b.i.d.
    Days 1 through 3: 0.0mg placebo once daily; days 4 through 7: 0.0mg placebo twice daily; days 8 through end of treatment: 0.0 mg placebo twice daily.
    Intervention: Drug: 0.0mg placebo Varenicline b.i.d.
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
 (submitted: June 4, 2018)
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:

  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.

Sex/Gender  ICMJE
Sexes Eligible for Study:All
Ages  ICMJE 21 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE
Contact: Scott J. Leischow, PhD602-827-2271[email protected]
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
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: No
IPD Sharing Statement  ICMJE
Plan to Share IPD:Undecided
Plan Description:While the exact process is unclear, when all data have been locked and investigators have published what they choose, de-identified data will be made available for the duration that we are required by NIH to maintain the data.
Responsible Party Arizona State University
Study Sponsor  ICMJE Arizona State University
Collaborators  ICMJE
  • National Institute on Drug Abuse (NIDA)
  • Los Angeles Clinical Trials
  • University of Nevada, Reno
  • Pfizer
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