Trial Outcomes & Findings for Combination of E-cigarettes and Varenicline for Tobacco Harm Reduction (NCT NCT04210180)

Last Updated: 2022-02-24

Results Overview

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.

Recruitment status

COMPLETED

Study phase

PHASE2/PHASE3

Target enrollment

25 participants

Primary outcome timeframe

Weeks 8-11

Results posted on

2022-02-24

Participant Flow

The study was conducted in both the Raleigh, NC and Charlotte, NC offices of Rose Research Center. Enrollment started on 19 Nov 2019 and ended on 08 Jul 2020.

Participant milestones

Participant milestones
Measure	Varenicline Plus E-cigarette 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. 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. e-cigarette: Each G6 prefilled cartomizer contains a 50/50 blend nicotine salt with 35mg nicotine strength.
Overall Study STARTED	25
Overall Study COMPLETED	23
Overall Study NOT COMPLETED	2

Reasons for withdrawal

Reasons for withdrawal
Measure	Varenicline Plus E-cigarette 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. 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. e-cigarette: Each G6 prefilled cartomizer contains a 50/50 blend nicotine salt with 35mg nicotine strength.
Overall Study Withdrawal by Subject	2

Baseline Characteristics

Combination of E-cigarettes and Varenicline for Tobacco Harm Reduction

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Varenicline Plus E-cigarette n=25 Participants 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. 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. e-cigarette: Each G6 prefilled cartomizer contains a 50/50 blend nicotine salt with 35mg nicotine strength.
Age, Continuous	46.92 years STANDARD_DEVIATION 9.10 • n=5 Participants
Sex: Female, Male Female	13 Participants n=5 Participants
Sex: Female, Male Male	12 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	2 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	23 Participants n=5 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants
Race (NIH/OMB) Asian	0 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	6 Participants n=5 Participants
Race (NIH/OMB) White	19 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants
Region of Enrollment United States	25 participants n=5 Participants

PRIMARY outcome

Timeframe: Weeks 8-11

Outcome measures

Outcome measures
Measure	Varenicline Plus E-cigarette n=25 Participants 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. 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. e-cigarette: Each G6 prefilled cartomizer contains a 50/50 blend nicotine salt with 35mg nicotine strength.
Number of Participant Reporting Continuous Complete Switching From Cigarettes to Halo G6	8 Participants

PRIMARY outcome

Timeframe: Weeks 8-11

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.

Outcome measures

Outcome measures
Measure	Varenicline Plus E-cigarette n=25 Participants 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. 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. e-cigarette: Each G6 prefilled cartomizer contains a 50/50 blend nicotine salt with 35mg nicotine strength.
Number of Participants Confirmed (by Expired Air CO) to Have Switched From Cigarettes to Halo G6	8 Participants

SECONDARY outcome

Timeframe: 6 months

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.

Outcome measures

Outcome measures
Measure	Varenicline Plus E-cigarette n=25 Participants 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. 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. e-cigarette: Each G6 prefilled cartomizer contains a 50/50 blend nicotine salt with 35mg nicotine strength.
Number of Participants Reporting Point Abstinence From Smoking Cigarettes at 6 Months Post-Switch	16 Participants

OTHER_PRE_SPECIFIED outcome

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

Population: 10 participants were not able to come to the lab for ABI evaluation at Visit 7 because of COVID restrictions.

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

Outcome measures

Outcome measures
Measure	Varenicline Plus E-cigarette n=13 Participants 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. 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. e-cigarette: Each G6 prefilled cartomizer contains a 50/50 blend nicotine salt with 35mg nicotine strength.
Mean Changes in Arterial Flow When Smokers Switch From Cigarettes to E-cigarettes	-0.05 ratio Standard Deviation 0.12

Adverse Events

Varenicline Plus E-cigarette

Serious events: 1 serious events

Other events: 22 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	Varenicline Plus E-cigarette n=25 participants at risk 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. 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. e-cigarette: Each G6 prefilled cartomizer contains a 50/50 blend nicotine salt with 35mg nicotine strength.
Musculoskeletal and connective tissue disorders Allergic Reaction to lidocaine	4.0% 1/25 • Number of events 1 • Data were collected during the 13 week study period.

Other adverse events

Other adverse events
Measure	Varenicline Plus E-cigarette n=25 participants at risk 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. 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. e-cigarette: Each G6 prefilled cartomizer contains a 50/50 blend nicotine salt with 35mg nicotine strength.
Gastrointestinal disorders Vomiting	8.0% 2/25 • Number of events 3 • Data were collected during the 13 week study period.
Gastrointestinal disorders Nausea	40.0% 10/25 • Number of events 10 • Data were collected during the 13 week study period.
Respiratory, thoracic and mediastinal disorders Cough	20.0% 5/25 • Number of events 5 • Data were collected during the 13 week study period.
Gastrointestinal disorders Constipation	8.0% 2/25 • Number of events 2 • Data were collected during the 13 week study period.
Nervous system disorders Headache	24.0% 6/25 • Number of events 6 • Data were collected during the 13 week study period.
Nervous system disorders Insomnia	16.0% 4/25 • Number of events 5 • Data were collected during the 13 week study period.
Nervous system disorders Nightmares/ Vivid Dreams	12.0% 3/25 • Number of events 3 • Data were collected during the 13 week study period.
Psychiatric disorders Agitation/Anxiety	8.0% 2/25 • Number of events 2 • Data were collected during the 13 week study period.
Respiratory, thoracic and mediastinal disorders Sore Throat	8.0% 2/25 • Number of events 2 • Data were collected during the 13 week study period.

Additional Information

Jed E. Rose, Ph.D.

Rose Research Center

Phone: 9193282345

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place