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Varenicline OTC Trial on Efficacy and Safety (VOTC)

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ClinicalTrials.gov Identifier: NCT03557294
Recruitment Status : Recruiting
First Posted : June 15, 2018
Last Update Posted : July 9, 2020
Sponsor:
Collaborators:
National Institute on Drug Abuse (NIDA)
Los Angeles Clinical Trials
University of Nevada, Reno
Pfizer
Information provided by (Responsible Party):
Arizona State University

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.

Condition or disease Intervention/treatment Phase
Tobacco Dependence Withdrawal Symptoms Smoking Cessation Drug: 1.0mg Varenicline b.i.d. Drug: 0.5mg Varenicline b.i.d. Drug: 0.0mg placebo Varenicline b.i.d. Phase 4

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 405 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Treatment
Official Title: Varenicline OTC Trial on Efficacy and Safety
Actual Study Start Date : May 7, 2018
Estimated Primary Completion Date : December 2021
Estimated Study Completion Date : June 2022

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
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.
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 α4β2 nicotinic receptor subtype.

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
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 α4β2 nicotinic receptor subtype.

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.
Drug: 0.0mg placebo Varenicline b.i.d.
Product that looks like active varenicline, but contains no active ingredient




Primary Outcome Measures :
  1. Breath carbon monoxide verified abstinence from smoking cigarettes [ Time Frame: Week 12 ]
    Participants will provide self reported smoking status that has been verified by breath carbon monoxide


Secondary Outcome Measures :
  1. Adverse events [ Time Frame: Week 2 visit ]
    Participants will be asked to report adverse events

  2. Adverse events [ Time Frame: Week 4 visit ]
    Participants will be asked to report adverse events

  3. Adverse events [ Time Frame: Week 8 visit ]
    Participants will be asked to report adverse events

  4. Adverse events [ Time Frame: Week 12 visit ]
    Participants will be asked to report adverse events

  5. Adverse events [ Time Frame: Week 13 visit ]
    Participants will be asked to report adverse events

  6. Adverse events [ Time Frame: Change in adverse events from baseline to week 2 as measured by 5 daily EMA prompts ]
    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

  7. Withdrawal symptoms and craving [ Time Frame: week 2 visit ]
    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.

  8. Withdrawal symptoms and craving [ Time Frame: week 4 visit ]
    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.

  9. Withdrawal symptoms and craving [ Time Frame: week 8 visit ]
    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.

  10. Withdrawal symptoms and craving [ Time Frame: week 12 visit ]
    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.

  11. Withdrawal symptoms and craving [ Time Frame: week 13 visit ]
    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.

  12. Craving [ Time Frame: change in craving from baseline to week 2 as measured by 5 daily EMA prompts ]
    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

  13. Breath carbon monoxide verified abstinence from smoking cigarettes [ Time Frame: Week 26 ]
    Participants who self report not smoking will be asked to have smoking status verified by breath carbon monoxide



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   21 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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.


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03557294


Contacts
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Contact: Scott J. Leischow, PhD 602-827-2271 scott.leischow@asu.edu

Locations
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United States, Arizona
Arizona State University Recruiting
Phoenix, Arizona, United States, 85004
Contact: Scott J. Leischow, PhD    602-827-2271    scott.leischow@asu.edu   
United States, California
Los Angeles Clinical Trials Recruiting
Burbank, California, United States, 91505
Contact: Mitchell Nides, PhD    818-526-7645    mnides@laclinicaltrials.com   
Sponsors and Collaborators
Arizona State University
National Institute on Drug Abuse (NIDA)
Los Angeles Clinical Trials
University of Nevada, Reno
Pfizer
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Responsible Party: Arizona State University
ClinicalTrials.gov Identifier: NCT03557294    
Other Study ID Numbers: 1R01DA044125 ( U.S. NIH Grant/Contract )
R01DA044125 ( U.S. NIH Grant/Contract )
First Posted: June 15, 2018    Key Record Dates
Last Update Posted: July 9, 2020
Last Verified: July 2020
Individual Participant Data (IPD) Sharing Statement:
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.

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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
Additional relevant MeSH terms:
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Tobacco Use Disorder
Substance Withdrawal Syndrome
Substance-Related Disorders
Chemically-Induced Disorders
Mental Disorders
Varenicline
Nicotinic Agonists
Cholinergic Agonists
Cholinergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs