Tobacco DependencePhase 4VOTCNCT03557294
Varenicline OTC Trial on Efficacy and Safety
A Phase 4 study testing 1.0mg Varenicline b.i.d. and 0.5mg Varenicline b.i.d. in people with Tobacco Dependence and Withdrawal Symptoms, run by Arizona State University at 2 sites in United States.
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. Read more about this study
- Who is it for?
- Ages 21 years and olderHealthy volunteers can take part
- Conditions the study is for
- Tobacco Dependence, Withdrawal Symptoms, Smoking Cessation
- What is being tested?
- 1.0mg Varenicline b.i.d. and 0.5mg Varenicline b.i.d.
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 313 participants
- Where
- 2 sitesUnited States
- Study dates
- 7 May 2018to 16 Apr 2022
- Phase
- Phase 4
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 21 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
Show all 19Show fewer
- 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)
- 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
Who cannot join
- 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
Show all 28Show fewer
- 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.
- 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.
Trial locations and contacts
2 sites in 1 country.
United States2 sites
Los Angeles Clinical Trials
Burbank, California, 91505
Arizona State University
Phoenix, Arizona, 85004
About this study
The primary goal of the proposed research is to test whether varenicline (Chantix) is safe and effective as an over-the-counter (OTC) medication.
Read the 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.
- Conditions
- Tobacco Dependence, Withdrawal Symptoms, Smoking Cessation
- Being tested
- 1.0mg Varenicline b.i.d., 0.5mg Varenicline b.i.d., 0.0mg placebo Varenicline b.i.d.
- Medical subject headings
- Tobacco Use Disorder, Substance Withdrawal Syndrome, Smoking Cessation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
1.0mg Varenicline b.i.d.Drug
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.
0.5mg Varenicline b.i.d.Drug
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.
0.0mg placebo Varenicline b.i.d.Drug
Product that looks like active varenicline, but contains no active ingredient
| Study group | Role | What they receive |
|---|---|---|
| 1.0mg varenicline b.i.d. | Experimental | 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. Receives: Drug: 1.0mg Varenicline b.i.d. |
| 0.5mg varenicline b.i.d. | Experimental | 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 Receives: Drug: 0.5mg Varenicline b.i.d. |
| 0.0mg placebo varenicline b.i.d. | Placebo comparator | 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. Receives: Drug: 0.0mg placebo Varenicline b.i.d. |
What is being measured
The primary outcome is the main question the study is designed to answer.
The Number of Participants Who Have Continuous Abstinence as Verified by Breath Carbon Monoxide or Urine Cotinine
Participants will provide self reported smoking status that has been verified by breath carbon monoxide or cotinine - Continuous abstinence
Measured: Week 12
Secondary outcomes (2)
Breath Carbon Monoxide or Urine Cotinine Verified Abstinence From Smoking Cigarettes - Point Prevalence Abstinence
Participants will provide self reported smoking status that has been verified by breath carbon monoxide or cotinine - point prevalence abstinence
Measured: Week 12 visit
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
Measured: Week 26
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Jun 2018
- Study start7 May 2018
- Primary completion16 Apr 2022
- Study completion16 Apr 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Tobacco DependenceStudies of the same condition, open and under way.
- More trials run by Arizona State UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 313 participants (actual)
Sponsor and investigators
- Lead sponsor
- Arizona State University
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute on Drug Abuse (NIDA), Los Angeles Clinical Trials, University of Nevada, Reno, Pfizer
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03557294
- Sponsor's protocol ID
- 1R01DA044125
- Other IDs
- R01DA044125
- Acronym
- VOTC
- Status last verified
- Sep 2024
- First submitted
- 15 May 2018
- Last updated
- 19 Sep 2024
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Undecided: 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.
Study at a glance
From the registry record, last updated by the sponsor on 19 Sep 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Varenicline OTC Trial on Efficacy and Safety
- ClinicalTrials.gov ID
- NCT03557294
- Acronym / sponsor ID
- VOTC / 1R01DA044125
- Conditions
- Tobacco Dependence, Withdrawal Symptoms, Smoking Cessation
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 313 participants (actual)
- Lead sponsor
- Arizona State UniversityUniversity, hospital or other
- Collaborators
- National Institute on Drug Abuse (NIDA), Los Angeles Clinical Trials, University of Nevada, Reno, Pfizer
- Study start
- 7 May 2018 (actual)
- Primary completion
- 16 Apr 2022 (actual)
- Study completion
- 16 Apr 2022 (actual)
- First posted
- 15 Jun 2018 (actual)
- Results
- Posted 19 Sep 2024
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| 1.0mg varenicline b.i.d. | Experimental | Drug: 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. |
| 0.5mg varenicline b.i.d. | Experimental | Drug: 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 |
| 0.0mg placebo varenicline b.i.d. | Placebo comparator | Drug: 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. |
Who may qualify
- Ages
- 21 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (19 listed)
- 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
Key exclusion criteria (28 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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 α4β2 nicotinic receptor subtype. | Drug | 1.0mg varenicline b.i.d. |
| 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 α4β2 nicotinic receptor subtype. | Drug | 0.5mg varenicline b.i.d. |
| 0.0mg placebo Varenicline b.i.d.Product that looks like active varenicline, but contains no active ingredient | Drug | 0.0mg placebo varenicline b.i.d. |
Primary outcome
The Number of Participants Who Have Continuous Abstinence as Verified by Breath Carbon Monoxide or Urine Cotinine
Time frame: Week 12
Participants will provide self reported smoking status that has been verified by breath carbon monoxide or cotinine - Continuous abstinence
2 secondary outcomes
Breath Carbon Monoxide or Urine Cotinine Verified Abstinence From Smoking Cigarettes - Point Prevalence Abstinence
Time frame: Week 12 visit
Breath Carbon Monoxide Verified Abstinence From Smoking Cigarettes
Time frame: Week 26
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Sep 2024.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: Undecided. 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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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing 1.0mg Varenicline b.i.d. and 0.5mg Varenicline b.i.d. in people with Tobacco Dependence and Withdrawal Symptoms, run by Arizona State University at 2 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 19 inclusion and 28 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 19 Sep 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 19 Sep 2024). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The Number of Participants Who Have Continuous Abstinence as Verified by Breath Carbon Monoxide or Urine Cotinine (time frame: Week 12). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Sep 2024.