Varenicline OTC Trial on Efficacy and Safety

• Status: Recruiting
• Trial end date: 2022-06-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 4
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: Arizona State University
• Collaborators: Los Angeles Clinical Trials; National Institute on Drug Abuse (NIDA); Pfizer; University of Nevada, Reno
• Treatments: Varenicline

Criteria

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.