CompletedPhase 2

Assisting Smokers to Switch to an e-Cigarette by Accelerating Learning of Adaptive Habits Using D-cycloserine

United States25 participantsStarted 2023-10-20

Plain-language summary

This study will evaluate the effects of a reward devaluation strategy, which has been researched in the past, combined/augmented with the medication d-cycloserine in assisting smokers to switch from combustible cigarette (CC) to Juul.

Who can participate

Age range

22 Years – 65 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion criteria

. Has signed the informed consent form (ICF) and is able to understand the information provided in the ICF.
. Is 22 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 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, ECG, concomitant medications and medical history).
. Patient Health Questionnaire (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.

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Smoking Abstinence based on Self-Report

Timeframe: During weeks 3-6 and 9-12 post-switching date.

Smoking Abstinence based on Expired Air Carbon Monoxide (CO)

Timeframe: End of Week 6, End of Week 12

Trial details

NCT IDNCT05994703

SponsorRose Research Center, LLC

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2025-10-13

View on ClinicalTrials.gov More Smoking Cessation trials