NCT04188197: RECON

Assisting Smokers to Switch to a JUUL E-Cigarette by Devaluing Combustible Cigarettes

Completed NA Results posted Last updated 20 April 2025

What this trial tests

NA trial testing JUUL in Smoking Cessation in 50 participants. Completed in 22 June 2021.

Timeline

26 August 2019

Primary endpoint
2 March 2021

22 June 2021

Quick facts

Lead sponsor	Rose Research Center, LLC
Phase	NA
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	none
Primary purpose	treatment
Enrollment	50
Start date	26 August 2019
Primary completion	2 March 2021
Estimated completion	22 June 2021
Sites	2 locations across United States

Drugs / interventions tested

• JUUL

Conditions studied

• Smoking Cessation — all drugs for Smoking Cessation →
• Harm Reduction — all drugs for Harm Reduction →
• E-Cig Use — all drugs for E-Cig Use →
• Cigarette Smoking — all drugs for Cigarette Smoking →

Sponsor

Rose Research Center, LLC — full company profile →

Who can join

Adults 21 to 65, any sex, with Smoking Cessation or Harm Reduction. Patients with the condition only — healthy volunteers not accepted.

Results — posted to ClinicalTrials.gov

Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.

Effects of Devaluation on Switching From Cigarettes to the JUUL E-cigarette Primary · 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.

Group	Value	95% CI
e-Cigarette Matched to Usual Brand Cigarette	4
e-Cigarette Unmatched to Usual Brand Cigarette	4

Changes in Cigarette Reward With Subsequent Switching Behavior Secondary · Week 1

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.

Change in Satisfaction scale of mCEQ at 1 week (V3) minus baseline (V2)

Group	Value	95% CI
e-Cigarette Matched to Usual Brand Cigarette	-0.8	± 1.0
e-Cigarette Unmatched to Usual Brand Cigarette	-0.8	± 1.2

Change in Psych Reward scale of mCEQ at 1 week (V3) minus baseline (V2)

Group	Value	95% CI
e-Cigarette Matched to Usual Brand Cigarette	-0.1	± 1.1
e-Cigarette Unmatched to Usual Brand Cigarette	-0.4	± 0.9

Adverse events — posted to ClinicalTrials.gov

Time frame: 12 weeks. Reporting threshold: 5%. Adverse-event reports describe events observed during the trial — not all are caused by the drug.

e-Cigarette Matched to Usual Brand Cigarette

Serious: 0/25 (0%)

Deaths: 0/25

e-Cigarette Unmatched to Usual Brand Cigarette

Serious: 0/25 (0%)

Deaths: 0/25

Other adverse events (5 terms — click to expand)

Reaction	System	e-Cigarette Matched to Usu…	e-Cigarette Unmatched to U…
Cough	Respiratory, thoracic and mediastinal disorders	—	—
Upper Respiratory Infection	Respiratory, thoracic and mediastinal disorders	—	—
Headache	Nervous system disorders	—	—
Nausea	Nervous system disorders	—	—
Elevated Blood Pressure	Cardiac disorders	—	—

Data from ClinicalTrials.gov NCT04188197 adverse events section.

Sponsor's own description

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.

Publications & conference data

No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.