- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04210180
Combination of E-cigarettes and Varenicline for Tobacco Harm Reduction (EVAR)
Study Overview
Status
Conditions
Intervention / Treatment
Study Type
Enrollment (Actual)
Phase
- Phase 2
- Phase 3
Contacts and Locations
Study Locations
-
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North Carolina
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Charlotte, North Carolina, United States, 28262
- Rose Research Center
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Raleigh, North Carolina, United States, 27617
- Rose Research Center
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: 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.
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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 Names:
Each G6 prefilled cartomizer contains a 50/50 blend nicotine salt with 35mg nicotine strength.
Other Names:
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Number of Participant Reporting Continuous Complete Switching From Cigarettes to Halo G6
Time Frame: Weeks 8-11
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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.
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Weeks 8-11
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Number of Participants Confirmed (by Expired Air CO) to Have Switched From Cigarettes to Halo G6
Time Frame: Weeks 8-11
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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.
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Weeks 8-11
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Number of Participants Reporting Point Abstinence From Smoking Cigarettes at 6 Months Post-Switch
Time Frame: 6 months
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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.
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6 months
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Other Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Mean Changes in Arterial Flow When Smokers Switch From Cigarettes to E-cigarettes
Time Frame: Baseline (Visit 1) and 13 weeks (Visit 7)
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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)
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Collaborators and Investigators
Sponsor
Collaborators
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- EVAR
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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