Varenicline OTC Trial on Efficacy and Safety

Smoking Cessation Clinical Trial

— VOTC  

Official title:

Varenicline OTC Trial on Efficacy and Safety

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03557294
• Other study ID #: 1R01DA044125
• Secondary ID: R01DA044125
• Status: Completed
• Phase: Phase 4
• Start date: May 7, 2018
• Est. completion date: April 16, 2022

Study information

• Verified date: April 2022
• Source: Arizona State University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 307
• Est. completion date: April 16, 2022
• Est. primary completion date: April 16, 2022
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 21 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Smoking Cessation
• Substance Withdrawal Syndrome
• Tobacco Dependence
• Tobacco Use Disorder
• Withdrawal Symptoms

Intervention

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 a4ß2 nicotinic receptor subtype.
• 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 a4ß2 nicotinic receptor subtype.
• 0.0mg placebo Varenicline b.i.d.
Product that looks like active varenicline, but contains no active ingredient

Locations

Country	Name	City	State
United States	Los Angeles Clinical Trials	Burbank	California
United States	Arizona State University	Phoenix	Arizona

Sponsors (5)

Lead Sponsor	Collaborator
Arizona State University	Los Angeles Clinical Trials, National Institute on Drug Abuse (NIDA), Pfizer, University of Nevada, Reno

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Breath carbon monoxide verified abstinence from smoking cigarettes	Participants will provide self reported smoking status that has been verified by breath carbon monoxide	Week 12
Secondary	Adverse events	Participants will be asked to report adverse events	Week 2 visit
Secondary	Adverse events	Participants will be asked to report adverse events	Week 4 visit
Secondary	Adverse events	Participants will be asked to report adverse events	Week 8 visit
Secondary	Adverse events	Participants will be asked to report adverse events	Week 12 visit
Secondary	Adverse events	Participants will be asked to report adverse events	Week 13 visit
Secondary	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	Change in adverse events from baseline to week 2 as measured by 5 daily EMA prompts
Secondary	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.	week 2 visit
Secondary	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.	week 4 visit
Secondary	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.	week 8 visit
Secondary	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.	week 12 visit
Secondary	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.	week 13 visit
Secondary	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	change in craving from baseline to week 2 as measured by 5 daily EMA prompts
Secondary	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	Week 26