Varenicline OTC Trial on Efficacy and Safety

NCT03557294 | Completed Phase 4 Results FDA Drug

• 2 other identifiers: 1R01DA044125R01DA044125
• Study Type: interventional
• Target: 313
• Locations: 1 country
• Sites: 2

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.

Conditions

Tobacco Dependence; Withdrawal Symptoms; Smoking Cessation

Outcome Measures

Primary Outcomes (1)

• 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

  Week 12

Secondary Outcomes (2)

• Breath Carbon Monoxide or Urine Cotinine Verified Abstinence From Smoking Cigarettes - Point Prevalence Abstinence

  Week 12 visit

• Breath Carbon Monoxide Verified Abstinence From Smoking Cigarettes

  Week 26

Study Arms (3)

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.

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

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.

Drug: 0.0mg placebo Varenicline b.i.d.

Interventions

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.

1.0mg varenicline b.i.d.

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.

0.5mg varenicline b.i.d.

0.0mg placebo Varenicline b.i.d. DRUG

Product that looks like active varenicline, but contains no active ingredient

0.0mg placebo varenicline b.i.d.

Eligibility Criteria

• Age: 21 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)

You may not qualify if:

• 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.

Sponsors & Collaborators

• Arizona State University: lead
• National Institute on Drug Abuse (NIDA): collaborator
• Los Angeles Clinical Trials: collaborator
• University of Nevada, Reno: collaborator
• Pfizer: collaborator

Study Sites (2)

Arizona State University

Phoenix, Arizona, 85004, United States

Location

Los Angeles Clinical Trials

Burbank, California, 91505, United States

Location

MeSH Terms

Conditions

Tobacco Use Disorder; Substance Withdrawal Syndrome; Smoking Cessation

Condition Hierarchy (Ancestors)

Substance-Related Disorders; Chemically-Induced Disorders; Mental Disorders; Health Behavior; Behavior

Limitations and Caveats

Note that the study was interrupted because of COVID.

Results Point of Contact

• Title: Scott Leischow, PhD
• Organization: Arizona State University

scott.leischow@asu.edu

602-496-3300

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 15, 2018
• First Posted: June 15, 2018
• Study Start: May 7, 2018
• Primary Completion: April 16, 2022
• Study Completion: April 16, 2022
• Last Updated: September 19, 2024
• Results First Posted: September 19, 2024

Record last verified: 2024-09

Locations

US (2)