Smoking CessationRECONNCT04188197
Assisting Smokers to Switch to a JUUL E-Cigarette by Devaluing Combustible Cigarettes
A study testing JUUL in people with Smoking Cessation and Harm Reduction, run by Rose Research Center, LLC at 2 sites in United States.
Trial summary
This study will evaluate a reward devaluation strategy in which smokers use the JUUL e-cigarette immediately before any combustible cigarettes (CCs) are smoked. This procedure is predicted to accomplish three goals: 1) the rewarding effects of CC will be disrupted because subjects will already have attained fairly… 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, E-Cig Use
- What is being tested?
- JUUL
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 2 sitesUnited States
- Study dates
- 26 Aug 2019to 22 Jun 2021
- Phase
- Interventional
- 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 understand the information provided in the ICF.
- Is 21 to 65 years of age (inclusive) at screening.
- Smokes ≥ 10 commercially available CCs per day (no brand restrictions), for the last 12 months.
- Expired air CO reading of at least 10 ppm as assessed at the screening session.
- Interested in switching to an electronic cigarette.
- Willing and able to comply with the requirements of the study.
- Owns a smartphone 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, 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 mm Hg, diastolic >95 mm Hg) 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 14Show fewer
- Has received psychotherapy or behavioral treatments within 30 days of screening, or during the study.
- Taking antidepressants or psychoactive medications (e.g. antipsychotics, benzodiazepines, hypnotics).
- Use of any of these products in the past 30 days:
- Illegal drugs (or if the urine drug screen is positive for cocaine, THC, amphetamines, methamphetamines, or opiates);
- Experimental (investigational) drugs that are unknown to the subject;
- 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 positive pregnancy test.
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 study will evaluate a reward devaluation strategy in which smokers use the JUUL e-cigarette immediately before any combustible cigarettes (CCs) are smoked. This procedure is predicted to accomplish three goals: 1) the rewarding effects of CC will be disrupted because subjects will already have attained fairly high peak nicotine concentrations immediately before smoking the cigarette. This reduces the rewarding effect of smoking, in part from receptor desensitization that occurs following nicotine exposure, which reduces the response to a subsequent dose of nicotine, and in part from satiating the drive to smoke; 2) the use of the JUUL will become associated with the same cues that elicit smoking, thereby promoting the substitution of JUUL use for CC use; and 3) ad libitum nicotine intake from the JUUL and its rewarding effects will be maximized because, unlike CC, they will be experienced after a period of nicotine deprivation. Thus, despite a lower per-puff nicotine dose relative to CC, the pharmacologic impact and reinforcing effect will be maximized. The study will evaluate two flavors (Mint and Virginia Tobacco), randomly assigned, to determine if flavor assignment (similar to the subjects' usual brand of CC or different than the subjects usual brand CC) has an effect on the success of this reconditioning procedure.
- Conditions
- Smoking Cessation, Harm Reduction, E-Cig Use, Cigarette Smoking, Tobacco Dependence, Tobacco Use Cessation
- Being tested
- JUUL
- Medical subject headings
- Smoking Cessation, Harm Reduction, Vaping, Cigarette Smoking, Tobacco Use Disorder, Tobacco Use Cessation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
JUULOther
Subjects will be instructed to use the JUUL as often as they like during the 12-week product use period. They will also be instructed to use JUUL immediately before each cigarette to relieve their craving as much as possible before smoking their usual brand. The JUUL will also be the first product that they are instructed to use each morning. Smokers will be told to try to completely substitute JUUL for cigarettes by the end of the first week of use.
| Study group | Role | What they receive |
|---|---|---|
| e-Cigarette Matched to Usual Brand Cigarette | Experimental | JUUL and cigarette flavor matched ("Mint" for menthol smokers and "Virginia Tobacco" for non-menthol smokers); Receives: Other: JUUL |
| e-Cigarette Unmatched to Usual Brand Cigarette | Experimental | JUUL and cigarette flavor unmatched ("Virginia Tobacco" for menthol smokers and "Mint" for non-menthol smokers). Receives: Other: JUUL |
What is being measured
The primary outcome is the main question the study is designed to answer.
Effects of Devaluation on Switching From Cigarettes to the JUUL E-cigarette
Biochemically verified smoking abstinence during weeks 9-12, i.e., self-report of no smoking confirmed by an expired air CO reading of <5 ppm.
Measured: During Weeks 9-12
Secondary outcomes (1)
Changes in Cigarette Reward With Subsequent Switching Behavior
Characterize changes in the two primary scales of the Cigarette Evaluation Questionnaire (mCEQ), assessing smoking satisfaction and psychological reward, over the first week of the study period. The mCEQ uses a 7-point scale (0=Not at all; 1=Very little; 2=A little; 3=Moderately; 4=A lot, 5=Quite a lot; 6=Extremely) to measure all subscales: Satisfaction, Psychological Reward, Enjoyment of Respiratory Tract Sensations, Craving Reduction, Aversion. Both subscales have the same "7-point scale" range.
Measured: Week 1
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Dec 2019
- Study start26 Aug 2019
- Primary completion2 Mar 2021
- Study completion22 Jun 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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 50 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
- NCT04188197
- Sponsor's protocol ID
- RECON
- Acronym
- RECON
- Status last verified
- Apr 2025
- First submitted
- 9 Sep 2019
- Last updated
- 20 Apr 2025
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Apr 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Assisting Smokers to Switch to a JUUL E-Cigarette by Devaluing Combustible Cigarettes
- ClinicalTrials.gov ID
- NCT04188197
- Acronym / sponsor ID
- RECON / RECON
- Conditions
- Smoking Cessation, Harm Reduction, E-Cig Use, Cigarette Smoking, Tobacco Dependence, Tobacco Use Cessation
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 50 participants (actual)
- Lead sponsor
- Rose Research Center, LLCIndustry (pharma, biotech, devices)
- Collaborators
- Foundation for a Smoke Free World INC
- Study start
- 26 Aug 2019 (actual)
- Primary completion
- 2 Mar 2021 (actual)
- Study completion
- 22 Jun 2021 (actual)
- First posted
- 5 Dec 2019 (actual)
- Results
- Posted 20 Apr 2025
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study will evaluate a reward devaluation strategy in which smokers use the JUUL e-cigarette immediately before any combustible cigarettes (CCs) are smoked. This procedure is predicted to accomplish three goals: 1) the rewarding effects of CC will be disrupted because subjects will already have attained fairly high peak nicotine concentrations immediately before smoking the cigarette. This reduces the rewarding effect of smoking, in part from receptor desensitization that occurs following nicotine exposure, which reduces the response to a subsequent dose of nicotine, and in part from satiating the drive to smoke; 2) the use of the JUUL will become associated with the same cues that elicit smoking, thereby promoting the substitution of JUUL use for CC use; and 3) ad libitum nicotine intake from the JUUL and its rewarding effects will be maximized because, unlike CC, they will be experienced after a period of nicotine deprivation. Thus, despite a lower per-puff nicotine dose relative to CC, the pharmacologic impact and reinforcing effect will be maximized. The study will evaluate two flavors (Mint and Virginia Tobacco), randomly assigned, to determine if flavor assignment (similar to the subjects' usual brand of CC or different than the subjects usual brand CC) has an effect on the success of this reconditioning procedure.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| e-Cigarette Matched to Usual Brand Cigarette | Experimental | Other: JUULJUUL and cigarette flavor matched ("Mint" for menthol smokers and "Virginia Tobacco" for non-menthol smokers); |
| e-Cigarette Unmatched to Usual Brand Cigarette | Experimental | Other: JUULJUUL and cigarette flavor unmatched ("Virginia Tobacco" for menthol smokers and "Mint" for non-menthol smokers). |
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 understand the information provided in the ICF.
- Is 21 to 65 years of age (inclusive) at screening.
- Smokes ≥ 10 commercially available CCs per day (no brand restrictions), for the last 12 months.
- Expired air CO reading of at least 10 ppm as assessed at the screening session.
- Interested in switching to an electronic cigarette.
Key exclusion criteria (14 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, 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 mm Hg, diastolic >95 mm Hg) 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 |
|---|---|---|
| JUULSubjects will be instructed to use the JUUL as often as they like during the 12-week product use period. They will also be instructed to use JUUL immediately before each cigarette to relieve their craving as much as possible before smoking their usual brand. The JUUL will also be the first product that they are instructed to use each morning. Smokers will be told to try to completely substitute JUUL for cigarettes by the end of the first week of use. | Other | e-Cigarette Matched to Usual Brand Cigarette, e-Cigarette Unmatched to Usual Brand Cigarette |
Primary outcome
Effects of Devaluation on Switching From Cigarettes to the JUUL E-cigarette
Time frame: During Weeks 9-12
Biochemically verified smoking abstinence during weeks 9-12, i.e., self-report of no smoking confirmed by an expired air CO reading of <5 ppm.
1 secondary outcome
Changes in Cigarette Reward With Subsequent Switching Behavior
Time frame: Week 1
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Apr 2025.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No
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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 study testing JUUL 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 14 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 20 Apr 2025. 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.
Are results available for this study?
Yes. Results are posted in the registry (first posted 20 Apr 2025). 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?
Effects of Devaluation on Switching From Cigarettes to the JUUL E-cigarette (time frame: During Weeks 9-12). 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 20 Apr 2025; AzTrials last refreshed its copy on 26 Oct 2026.