Combination of E-cigarettes and Varenicline for Tobacco H... | NCT04210180

NCT04210180

Protocol Section

Identification Module

Results Section

Participant Flow Module

Annotation Section

No data available

No data is available for this block.

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module

Status Module

Name	Class
Foundation for a Smoke Free World INC	OTHER

Description Module

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
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

Name	Type	Description	Arm Group Labels	Other Names
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.	Varenicline plus e-cigarette

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
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

Measure	Description	Time Frame
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

Other Outcomes

Measure	Description	Time Frame
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

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

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.

Exclusion Criteria:

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.

Facility	Status	City	State	ZIP	Country	Contacts
Rose Research Center		Charlotte	North Carolina	28262	United States
Rose Research Center

Arm/Group Information

ID	Title	Description
FG000	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.

Baseline Characteristics Module

Arm/Group Information

ID	Title	Description
BG000	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.

Units	Counts
Participants	BG000

Title	Description	Population Description	Parameter Type	Dispersion Type	Unit of Measure	Calculate Percentage	Denominator Units Selected	Denominators	Classes
Age, Continuous			Mean

Outcome Measures Module

Outcome Measures

Type

Title

Description

Population Description

Reporting Status

Anticipated Posting Date

Parameter Type

Dispersion Type

Unit of Measure

Calculate Percentage

Time Frame

Units Analyzed

Denominator Units Selected

Arm/Group Information

Denominators

Classes

Analyses

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.

Posted

Count of Participants

Participants

Weeks 8-11

ID	Title	Description
OG000	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.

Adverse Events Module

Arm/Groups

ID	Title	Description	Deaths (Affected)	Deaths (At Risk)	Serious Events (Affected)	Serious Events (At Risk)	Other Events (Affected)	Other Events (At Risk)
EG000	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.

Serious Adverse Events

Term	Organ System	Source Vocabulary	Assessment Type	Notes	Statistical Information
Allergic Reaction to lidocaine	Musculoskeletal and connective tissue disorders		Non-systematic Assessment	Muscular weakness caused by interarticular joint injection, requiring hospitalization, self-resolved within 48 hours.

ID	Term
D016540	Smoking Cessation
D040261	Harm Reduction

ID	Term
D015438	Health Behavior
D001519	Behavior

ID	Term
D001552	Benzazepines
D006574	Heterocyclic Compounds, 2-Ring
D000072471	Heterocyclic Compounds, Fused-Ring
D006571	Heterocyclic Compounds

ID	Term
D000068580	Varenicline
D066300	Electronic Nicotine Delivery Systems