Combination of E-cigarettes and Varenicline for Tobacco Harm Reduction

Smoking Cessation Clinical Trial

— EVAR  

Official title:

Combination of E-cigarettes and Varenicline for Tobacco Harm Reduction

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04210180
• Other study ID #: EVAR
• Status: Completed
• Phase: Phase 2/Phase 3
• Start date: November 19, 2019
• Est. completion date: March 22, 2021

Study information

• Verified date: February 2022
• Source: Rose Research Center, LLC
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 25
• Est. completion date: March 22, 2021
• Est. primary completion date: October 14, 2020
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 21 Years to 65 Years

Eligibility

Inclusion Criteria:

1. Has signed the ICF and is able to read and understand the information provided in the consent form.

2. Is 21 to 65 years of age (inclusive) at screening.

3. Smokes at least 10 commercially available cigarettes per day (no brand restrictions), for the last 12 months.

4. Has an expired air carbon monoxide reading of at least 10 ppm at screening.

5. Interested in switching to an electronic cigarette.

6. Willing and able to comply with the requirements of the study.

7. Owns a smart phone with text message and data capabilities compatible with necessary surveys.

Exclusion Criteria:

1. 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).

2. 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.

3. Planned use of an FDA-approved smoking cessation product during the study.

4. High blood pressure (systolic > 150 mmHg or diastolic >95 mmHg) at screening.

5. Body mass index (BMI) less than 15.0 kg/m2 or greater than 40.0 kg/m2.

6. 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.

7. Has received psychotherapy or behavioral treatments potentially impacting symptoms of depression, anxiety, or nicotine withdrawal within 30 days of screening, or during the study.

8. Taking antidepressants, psychoactive medications (e.g. antipsychotics, benzodiazepines, hypnotics) or medications that prolong QTc.

9. 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.

10. 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.

11. Pregnant or nursing (by self-report) or has a positive pregnancy test.

12. Enrollment requirements met.

Related Conditions & MeSH terms

• Harm Reduction
• Smoking Cessation

Intervention

Drug:
• Varenicline
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.

Other:
• e-cigarette
Each G6 prefilled cartomizer contains a 50/50 blend nicotine salt with 35mg nicotine strength.

Locations

Country	Name	City	State
United States	Rose Research Center	Charlotte	North Carolina
United States	Rose Research Center	Raleigh	North Carolina

Sponsors (2)

Lead Sponsor	Collaborator
Rose Research Center, LLC	Foundation for a Smoke-Free World

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Mean Changes in Arterial Flow When Smokers Switch From Cigarettes to E-cigarettes	Ankle-Brachial Index (ABI) use to evaluate vascular changes when smokers change from cigarettes to e-cigarettes over a 13-week period. Measurements will be obtained using a manual sphygmomanometer and an 8- to 10- MHz doppler ultrasound probe. Subjects will undergo this testing at Visit 1 (baseline data) and at the end of study (Visit 7).; Ankle Brachial Index (ABI) is the ratio of the blood pressure in the lower legs to the blood pressure in the arms. The normal range for the ankle-brachial index is between 0.90 and 1.30. An index of 0.41 to 0.90 indicates mild to moderate arterial disease and an index of 0.40 and lower indicates severe disease	Baseline (Visit 1) and 13 weeks (Visit 7)
Primary	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
Primary	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	Number of Participants Reporting Point Abstinence From Smoking Cigarettes at 6 Months Post-Switch	Point abstinence will be defined by a self-report of no cigarette smoking (not even a puff) in the last seven days at six months post-switch.	6 months