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Varenicline OTC Trial on Efficacy and Safety (VOTC)

Primary Purpose

Tobacco Dependence, Withdrawal Symptoms, Smoking Cessation

Status
Completed
Phase
Phase 4
Locations
United States
Study Type
Interventional
Intervention
1.0mg Varenicline b.i.d.
0.5mg Varenicline b.i.d.
0.0mg placebo Varenicline b.i.d.
Sponsored by
Arizona State University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Tobacco Dependence

Eligibility Criteria

21 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria for the In-person Cohort

  1. 21 years of age or older
  2. Self-reported daily smoker
  3. Breath CO > 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 for the In-person Cohort

  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 (see site applicable SOP for Evaluating and Reporting Blood Pressure and Appendices 5 and 6 for participant handouts)
  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.

Inclusion Criteria for the Remote Cohort

  1. 21 years of age or older
  2. Self-reported daily smoker
  3. Positive cotinine from urine sample
  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

10. Must own study compatible smart-phone (iPhone or Android) 11. Must be a current resident of the United States

Exclusion Criteria for the Remote Cohort

  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. History of renal disease
  5. Allergy to any of the ingredients in varenicline
  6. Participation in another smoking cessation program or any type of clinical trial in the past 3 months
  7. Use of any smoking cessation medication in the past three months
  8. Any other medical condition(s) which the licensed study physician deems unacceptable for participation in this study
  9. Consume greater than 21 alcohol drinks per week.
  10. No two members of the same household may participate in this study
  11. No study staff or their immediate family may participate in the study
  12. 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.

Sites / Locations

  • Arizona State University
  • Los Angeles Clinical Trials

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Experimental

Placebo Comparator

Arm Label

1.0mg varenicline b.i.d.

0.5mg varenicline b.i.d.

0.0mg placebo varenicline b.i.d.

Arm Description

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.

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

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.

Outcomes

Primary Outcome Measures

Breath carbon monoxide verified abstinence from smoking cigarettes
Participants will provide self reported smoking status that has been verified by breath carbon monoxide

Secondary Outcome Measures

Adverse events
Participants will be asked to report adverse events
Adverse events
Participants will be asked to report adverse events
Adverse events
Participants will be asked to report adverse events
Adverse events
Participants will be asked to report adverse events
Adverse events
Participants will be asked to report adverse events
Adverse events
A subset of participants will be asked to report adverse events via ecological momentary assessment (EMA). EMA asks questions via the participant mobile phone on multiple occasions, primarily at random
Withdrawal symptoms and craving
Participants will be asked to report withdrawal symptoms, as measured by the Minnesota Nicotine Withdrawal Scale (MNWS). Scores can be between 0 (absent) - 4 (severe), and the average scores will be assessed.
Withdrawal symptoms and craving
Participants will be asked to report withdrawal symptoms, as measured by the Minnesota Nicotine Withdrawal Scale (MNWS). Scores can be between 0 (absent) - 4 (severe), and the average scores will be assessed.
Withdrawal symptoms and craving
Participants will be asked to report withdrawal symptoms, as measured by the Minnesota Nicotine Withdrawal Scale (MNWS). Scores can be between 0 (absent) - 4 (severe), and the average scores will be assessed.
Withdrawal symptoms and craving
Participants will be asked to report withdrawal symptoms, as measured by the Minnesota Nicotine Withdrawal Scale (MNWS). Scores can be between 0 (absent) - 4 (severe), and the average scores will be assessed.
Withdrawal symptoms and craving
Participants will be asked to report withdrawal symptoms, as measured by the Minnesota Nicotine Withdrawal Scale (MNWS). Scores can be between 0 (absent) - 4 (severe), and the average scores will be assessed.
Craving
Participants will be asked to report craving via ecological momentary assessment (EMA). EMA asks questions via the participant mobile phone on multiple occasions, primarily at random
Breath carbon monoxide verified abstinence from smoking cigarettes
Participants who self report not smoking will be asked to have smoking status verified by breath carbon monoxide

Full Information

First Posted
May 15, 2018
Last Updated
April 29, 2022
Sponsor
Arizona State University
Collaborators
National Institute on Drug Abuse (NIDA), Los Angeles Clinical Trials, University of Nevada, Reno, Pfizer
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1. Study Identification

Unique Protocol Identification Number
NCT03557294
Brief Title
Varenicline OTC Trial on Efficacy and Safety
Acronym
VOTC
Official Title
Varenicline OTC Trial on Efficacy and Safety
Study Type
Interventional

2. Study Status

Record Verification Date
April 2022
Overall Recruitment Status
Completed
Study Start Date
May 7, 2018 (Actual)
Primary Completion Date
April 16, 2022 (Actual)
Study Completion Date
April 16, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Arizona State University
Collaborators
National Institute on Drug Abuse (NIDA), Los Angeles Clinical Trials, University of Nevada, Reno, Pfizer

4. Oversight

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
Data Monitoring Committee
No

5. Study Description

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: 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. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Tobacco Dependence, Withdrawal Symptoms, Smoking Cessation

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigator
Allocation
Randomized
Enrollment
307 (Actual)

8. Arms, Groups, and Interventions

Arm Title
1.0mg varenicline b.i.d.
Arm Type
Experimental
Arm Description
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.
Arm Title
0.5mg varenicline b.i.d.
Arm Type
Experimental
Arm Description
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
Arm Title
0.0mg placebo varenicline b.i.d.
Arm Type
Placebo Comparator
Arm Description
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 Type
Drug
Intervention Name(s)
1.0mg Varenicline b.i.d.
Intervention Description
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 α4β2 nicotinic receptor subtype.
Intervention Type
Drug
Intervention Name(s)
0.5mg Varenicline b.i.d.
Intervention Description
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 α4β2 nicotinic receptor subtype.
Intervention Type
Drug
Intervention Name(s)
0.0mg placebo Varenicline b.i.d.
Intervention Description
Product that looks like active varenicline, but contains no active ingredient
Primary Outcome Measure Information:
Title
Breath carbon monoxide verified abstinence from smoking cigarettes
Description
Participants will provide self reported smoking status that has been verified by breath carbon monoxide
Time Frame
Week 12
Secondary Outcome Measure Information:
Title
Adverse events
Description
Participants will be asked to report adverse events
Time Frame
Week 2 visit
Title
Adverse events
Description
Participants will be asked to report adverse events
Time Frame
Week 4 visit
Title
Adverse events
Description
Participants will be asked to report adverse events
Time Frame
Week 8 visit
Title
Adverse events
Description
Participants will be asked to report adverse events
Time Frame
Week 12 visit
Title
Adverse events
Description
Participants will be asked to report adverse events
Time Frame
Week 13 visit
Title
Adverse events
Description
A subset of participants will be asked to report adverse events via ecological momentary assessment (EMA). EMA asks questions via the participant mobile phone on multiple occasions, primarily at random
Time Frame
Change in adverse events from baseline to week 2 as measured by 5 daily EMA prompts
Title
Withdrawal symptoms and craving
Description
Participants will be asked to report withdrawal symptoms, as measured by the Minnesota Nicotine Withdrawal Scale (MNWS). Scores can be between 0 (absent) - 4 (severe), and the average scores will be assessed.
Time Frame
week 2 visit
Title
Withdrawal symptoms and craving
Description
Participants will be asked to report withdrawal symptoms, as measured by the Minnesota Nicotine Withdrawal Scale (MNWS). Scores can be between 0 (absent) - 4 (severe), and the average scores will be assessed.
Time Frame
week 4 visit
Title
Withdrawal symptoms and craving
Description
Participants will be asked to report withdrawal symptoms, as measured by the Minnesota Nicotine Withdrawal Scale (MNWS). Scores can be between 0 (absent) - 4 (severe), and the average scores will be assessed.
Time Frame
week 8 visit
Title
Withdrawal symptoms and craving
Description
Participants will be asked to report withdrawal symptoms, as measured by the Minnesota Nicotine Withdrawal Scale (MNWS). Scores can be between 0 (absent) - 4 (severe), and the average scores will be assessed.
Time Frame
week 12 visit
Title
Withdrawal symptoms and craving
Description
Participants will be asked to report withdrawal symptoms, as measured by the Minnesota Nicotine Withdrawal Scale (MNWS). Scores can be between 0 (absent) - 4 (severe), and the average scores will be assessed.
Time Frame
week 13 visit
Title
Craving
Description
Participants will be asked to report craving via ecological momentary assessment (EMA). EMA asks questions via the participant mobile phone on multiple occasions, primarily at random
Time Frame
change in craving from baseline to week 2 as measured by 5 daily EMA prompts
Title
Breath carbon monoxide verified abstinence from smoking cigarettes
Description
Participants who self report not smoking will be asked to have smoking status verified by breath carbon monoxide
Time Frame
Week 26

10. Eligibility

Sex
All
Minimum Age & Unit of Time
21 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria for the In-person Cohort 21 years of age or older Self-reported daily smoker Breath CO > 10ppm Motivated to quit smoking completely within five weeks of the Screening Visit (>5 on reported motivation) Capable of and agree to complete study requirements Literate in English, self-report Must be available for the duration of study Informed consent obtained Willing and able to provide additional data between visits using ecological momentary assessment (EMA) Must own study compatible smart-phone (iPhone or Android) Exclusion Criteria for the In-person Cohort Any self-report, diagnosis or treatment of heart attack, unstable angina, angioedema, seizures, cerebrovascular accident (CVA) within the last six months. 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) Self-report of diagnosis or treatment for depression within the past six months, unless participant has written permission by their healthcare provider to participate Systolic blood pressure 160 or higher and/or diastolic blood pressure 100 or higher (see site applicable SOP for Evaluating and Reporting Blood Pressure and Appendices 5 and 6 for participant handouts) History of renal disease Allergy to any of the ingredients in varenicline Participation in another smoking cessation program or any type of clinical trial in the past 3 months Use of any smoking cessation medication in the past three months Any other medical condition(s) which the licensed study physician deems unacceptable for participation in this study 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. Consume greater than 21 alcohol drinks per week. No two members of the same household may participate in this study No study staff or their immediate family may participate in the study 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. Inclusion Criteria for the Remote Cohort 21 years of age or older Self-reported daily smoker Positive cotinine from urine sample Motivated to quit smoking completely within five weeks of the Screening Visit (>5 on reported motivation) Capable of and agree to complete study requirements Literate in English, self-report Must be available for the duration of study Informed consent obtained 10. Must own study compatible smart-phone (iPhone or Android) 11. Must be a current resident of the United States Exclusion Criteria for the Remote Cohort Any self-report, diagnosis or treatment of heart attack, unstable angina, angioedema, seizures, cerebrovascular accident (CVA) within the last six months. 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) Self-report of diagnosis or treatment for depression within the past six months, unless participant has written permission by their healthcare provider to participate History of renal disease Allergy to any of the ingredients in varenicline Participation in another smoking cessation program or any type of clinical trial in the past 3 months Use of any smoking cessation medication in the past three months Any other medical condition(s) which the licensed study physician deems unacceptable for participation in this study Consume greater than 21 alcohol drinks per week. No two members of the same household may participate in this study No study staff or their immediate family may participate in the study 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.
Facility Information:
Facility Name
Arizona State University
City
Phoenix
State/Province
Arizona
ZIP/Postal Code
85004
Country
United States
Facility Name
Los Angeles Clinical Trials
City
Burbank
State/Province
California
ZIP/Postal Code
91505
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
Undecided
IPD Sharing 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.

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Varenicline OTC Trial on Efficacy and Safety

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