Smoking CessationPhase 2/3EVARNCT04210180
Combination of E-cigarettes and Varenicline for Tobacco Harm Reduction
A Phase 2/3 study testing Varenicline and e-cigarette in people with Smoking Cessation and Harm Reduction, run by Rose Research Center, LLC at 2 sites in United States.
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… Read more about this study
- Who is it for?
- Ages 21 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Smoking Cessation, Harm Reduction
- What is being tested?
- Varenicline and e-cigarette
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 25 participants
- Where
- 2 sitesUnited States
- Study dates
- 19 Nov 2019to 22 Mar 2021
- Phase
- Phase 2/3
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 21 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Show all 12Show fewer
- 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.
Trial locations and contacts
2 sites in 1 country.
United States2 sites
Rose Research Center
Charlotte, North Carolina, 28262
Rose Research Center
Raleigh, North Carolina, 27617
About this study
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
- Being tested
- Varenicline, e-cigarette
- Medical subject headings
- Smoking Cessation, Harm Reduction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
VareniclineDrug
Also called Chantix
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-cigaretteOther
Also called Halo G6
Each G6 prefilled cartomizer contains a 50/50 blend nicotine salt with 35mg nicotine strength.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Drug: Varenicline; Other: e-cigarette |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: Weeks 8-11
Secondary outcomes (1)
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.
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Dec 2019
- Study start19 Nov 2019
- Primary completion14 Oct 2020
- Study completion22 Mar 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Smoking CessationStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2/3
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 25 participants (actual)
Sponsor and investigators
- Lead sponsor
- Rose Research Center, LLC
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Foundation for a Smoke Free World INC
- Responsible party
- Principal investigator, Jed Rose, Rose Research Center, LLC
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04210180
- Sponsor's protocol ID
- EVAR
- Acronym
- EVAR
- Status last verified
- Feb 2022
- First submitted
- 4 Dec 2019
- Last updated
- 24 Feb 2022
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Feb 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Combination of E-cigarettes and Varenicline for Tobacco Harm Reduction
- ClinicalTrials.gov ID
- NCT04210180
- Acronym / sponsor ID
- EVAR / EVAR
- Conditions
- Smoking Cessation, Harm Reduction
- Phase
- Phase 2/3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 25 participants (actual)
- Lead sponsor
- Rose Research Center, LLCIndustry (pharma, biotech, devices)
- Collaborators
- Foundation for a Smoke Free World INC
- Study start
- 19 Nov 2019 (actual)
- Primary completion
- 14 Oct 2020 (actual)
- Study completion
- 22 Mar 2021 (actual)
- First posted
- 24 Dec 2019 (actual)
- Results
- Posted 8 Feb 2022
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Varenicline plus e-cigarette | Experimental | Drug: Varenicline, Other: e-cigaretteParticipants 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. |
Who may qualify
- Ages
- 21 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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.
Key exclusion criteria (12 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| VareniclineAlso: Chantix0.5 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. | Drug | Varenicline plus e-cigarette |
| e-cigaretteAlso: Halo G6Each G6 prefilled cartomizer contains a 50/50 blend nicotine salt with 35mg nicotine strength. | Other | Varenicline plus e-cigarette |
Primary outcome
Number of Participant Reporting Continuous Complete Switching From Cigarettes to Halo G6
Time frame: 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 will be defined by a self-report of no cigarette smoking (not even a puff) since the prior session.
Number of Participants Confirmed (by Expired Air CO) to Have Switched From Cigarettes to Halo G6
Time frame: 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.
1 secondary outcome
Number of Participants Reporting Point Abstinence From Smoking Cigarettes at 6 Months Post-Switch
Time frame: 6 months
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Feb 2022.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No
Related trials for Smoking Cessation
Enrolling by invitationObservational study
Using Smartwatches to Monitor Smoking in Real-life Situations
Smoking
Not yet recruitingObservational study
PROMETHEE: A Shared Interregional Tele-Tobacco Cessation Platform Embedded Within the IMPULSION Lung Cancer Screening Program
Smoking Cessation, Lung Cancer Screening
Not yet recruiting
Impacto 2.0: Mobile Smoking Cessation Across Texas
Cigarette Smoking, Smoking Cessation
Not yet recruiting
Smoking Cessation Program for Lao People With HIV
Smoking Cessation, HIV
RecruitingPhase 3
Studying NMDA and Sigma-1 in Smoking Cessation Treatment (SUMMIT)
Smoking Cessation
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2/3 study testing Varenicline and e-cigarette in people with Smoking Cessation and Harm Reduction, run by Rose Research Center, LLC at 2 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 24 Feb 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 8 Feb 2022). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of Participant Reporting Continuous Complete Switching From Cigarettes to Halo G6 (time frame: Weeks 8-11). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Feb 2022.