Combination of E-cigarettes and Varenicline for Tobacco Harm Reduction

NCT04210180 | Completed Phase 2 Results FDA Drug

• 1 other identifier: EVAR
• Study Type: interventional
• Target: 25
• Locations: 1 country
• Sites: 2

Brief Summary

This open-label study will explore the impact of varenicline on the process of switching from combustible cigarettes (CC) to an e-cigarette. Varenicline is currently the most efficacious single pharmacotherapy for smoking cessation, and through its actions as an agonist or partial agonist at various nicotinic acetylcholine receptor subtypes, serves to diminish the rewarding effects of cigarette smoking. Diminishing the rewarding effects of smoking might facilitate the transition from CC to e-cigarettes. On the other hand, varenicline might attenuate the rewarding effects of nicotine-containing e-cigarettes as well, which could hamper the transition. Thus, the study will provide important information about the actions of varenicline on CC as well as e-cigarettes. There is no therapeutic intent in that smokers' nicotine/tobacco dependence will not be treated; the goal is to switch from one form of nicotine/tobacco dependence (CC) to dependence on a different tobacco product (e-cigarettes).

Conditions

Smoking Cessation; Harm Reduction

Outcome Measures

Primary Outcomes (2)

• Number of Participant Reporting Continuous Complete Switching From Cigarettes to Halo G6

  The primary switching outcome will be smoking abstinence during weeks 8-11 post-switching date. Complete switching from combustible cigarette use at each time point will be defined by a self-report of no cigarette smoking (not even a puff) since the prior session.

  Weeks 8-11

• Number of Participants Confirmed (by Expired Air CO) to Have Switched From Cigarettes to Halo G6

  The primary switching outcome will be smoking abstinence during weeks 8-11 post-switching date. Complete switching from combustible cigarette use at each time point confirmed by an expired air CO reading of less than 5 ppm.

  Weeks 8-11

Secondary Outcomes (1)

• Number of Participants Reporting Point Abstinence From Smoking Cigarettes at 6 Months Post-Switch

  6 months

Other Outcomes (1)

• Mean Changes in Arterial Flow When Smokers Switch From Cigarettes to E-cigarettes

  Baseline (Visit 1) and 13 weeks (Visit 7)

Study Arms (1)

Varenicline plus e-cigarette

EXPERIMENTAL

Participants enrolled in the study will receive a G6 e-cigarette at V2 for ad libitum use. The FDA approved starter kit of varenicline will be provided to participants at V3 (0.5 mg nightly for days 1-3, then 0.5 mg twice daily for days 4-7) along with additional G6 cartomizers. After the first week of varenicline, participants will receive the FDA-approved standard dose of varenicline (1 mg twice daily) and will continue to receive enough G6 cartomizers for the next 11 weeks.

Drug: Varenicline; Other: e-cigarette

Interventions

Varenicline DRUG

0.5 mg nightly for days 1-3, then 0.5 mg twice daily for days 4-7; then 1 mg twice daily for the remaining 11 weeks.

Also known as: Chantix

Varenicline plus e-cigarette

e-cigarette OTHER

Each G6 prefilled cartomizer contains a 50/50 blend nicotine salt with 35mg nicotine strength.

Also known as: Halo G6

Varenicline plus e-cigarette

Eligibility Criteria

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

You may qualify if:

• Has signed the ICF and is able to read and understand the information provided in the consent form.
• Is 21 to 65 years of age (inclusive) at screening.
• Smokes at least 10 commercially available cigarettes per day (no brand restrictions), for the last 12 months.
• Has an expired air carbon monoxide reading of at least 10 ppm at screening.
• Interested in switching to an electronic cigarette.
• Willing and able to comply with the requirements of the study.
• Owns a smart phone with text message and data capabilities compatible with necessary surveys.

You may not qualify if:

• Is unhealthy or cannot participate in the study for any reason (e.g., medical, psychiatric, and/or social reason) as judged by the Investigator or designated medical staff based on all available assessments from the screening period (e.g., safety laboratory, vital signs, physical examination, Ankle-Brachial Index, ECG, concomitant medications and medical history).
• PHQ-9 score greater than 9, or a score greater than 0 on item #9 ("Thoughts that you would be better off dead, or of hurting yourself in some way") at screening.
• Planned use of an FDA-approved smoking cessation product during the study.
• High blood pressure (systolic \> 150 mmHg or diastolic \>95 mmHg) at screening.
• Body mass index (BMI) less than 15.0 kg/m2 or greater than 40.0 kg/m2.
• Coronary heart disease, structural cardiac disease (including, but not limited to valvular heart disease or cardiac murmurs), cardiac dysrhythmias, syncope, cardiac chest pain, or history of heart attack or heart failure.
• Has received psychotherapy or behavioral treatments potentially impacting symptoms of depression, anxiety, or nicotine withdrawal within 30 days of screening, or during the study.
• Taking antidepressants, psychoactive medications (e.g. antipsychotics, benzodiazepines, hypnotics) or medications that prolong QTc.
• Use of any of these products in the past 30 days: a. Illegal drugs (or if the urine drug screen is positive for cocaine, THC, amphetamines, methamphetamines, or opiates); b. Experimental (investigational) drugs that are unknown to subject; c. Chronic opiate use.
• Use of smokeless tobacco (chewing tobacco, snuff), cigars (except for "Black \& Mild" cigars or Cigarillos), pipes, hookah, e-cigarettes, nicotine replacement therapy or other smoking cessation treatments within 14 days of screening.
• Pregnant or nursing (by self-report) or has a positive pregnancy test.
• Enrollment requirements met.

Sponsors & Collaborators

• Rose Research Center, LLC: lead
• Foundation for a Smoke Free World INC: collaborator

Study Sites (2)

Rose Research Center

Charlotte, North Carolina, 28262, United States

Location

Rose Research Center

Raleigh, North Carolina, 27617, United States

Location

MeSH Terms

Conditions

Smoking Cessation; Harm Reduction

Interventions

Varenicline; Electronic Nicotine Delivery Systems

Condition Hierarchy (Ancestors)

Health Behavior; Behavior

Intervention Hierarchy (Ancestors)

Benzazepines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds; Quinoxalines; Smoking Devices; Manufactured Materials; Technology, Industry, and Agriculture

Results Point of Contact

• Title: Jed E. Rose, Ph.D.
• Organization: Rose Research Center

jed.rose@roseresearchcenter.com

9193282345

Publication Agreements

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

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: President and CEO

Study Record Dates

• First Submitted: December 4, 2019
• First Posted: December 24, 2019
• Study Start: November 19, 2019
• Primary Completion: October 14, 2020
• Study Completion: March 22, 2021
• Last Updated: February 24, 2022
• Results First Posted: February 8, 2022

Record last verified: 2022-02

Data Sharing

• IPD Sharing: Will not share

Locations

US (2)