ClinicalTrials.gg
CompletedNCT05994703Updated Jan 20, 2026

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

A Phase 2 interventional study of d-cycloserine and Juul e-cigarette in Smoking Cessation and Harm Reduction, sponsored by Rose Research Center, LLC. Completed at 2 sites in United States. Open to participants aged 22 Years to 65 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-01-20.

Sponsored by Rose Research Center, LLC · Phase 2, Interventional, and Treatment

From the registry’s dates

  • Primary completion was Oct 2025, 1 year ago, and no results have been posted to the registry.
Phase
Phase 2
Study type
Interventional
Enrollment
25
Allocation
Not applicable
Ages
22 Years to 65 Years
Sex
All
01

Study 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.

02

Conditions studied

  • Smoking Cessation
  • Harm Reduction
03

In context

Smoking Cessation

1,581 studies on the registry are indexed under Smoking Cessation; 198 are open to participants now.

This study's enrollment of 25 is below the median of 164 across 1,423 interventional studies indexed under Smoking Cessation.

Browse Smoking Cessation studies →

Lead sponsor

Rose Research Center, LLC is the lead sponsor of 13 studies on the registry; none are open to participants now.

Of its 8 completed or terminated interventional studies of FDA-regulated products, 3 (38%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
22 Years to 65 Years
Sexes eligible
All
Accepts healthy volunteers
Yes

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  1. Has signed the form (ICF) and is able to understand the information provided in the ICF.
  2. Is 22 to 65 years of age (inclusive) at screening.
  3. Smokes ≥ 10 commercially available CCs per day (no brand restrictions), for the last 12 months.
  4. Expired air CO reading of at least 10 ppm as assessed at the screening session.
  5. Interested in switching to an electronic cigarette.
  6. Willing and able to comply with the requirements of the study.
  7. Owns a smart phone with text message and data capabilities compatible with necessary surveys.

Exclusion criteria

Exclusion Criteria:

  1. 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, , concomitant medications and medical history).
  2. 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.
  3. Planned use of an FDA-approved smoking cessation product during the study.
  4. High Blood Pressure (systolic >150 mm Hg, diastolic >95 mm Hg) at screening.
  5. (BMI) less than 15.0 kg/m2 or greater than 40.0 kg/m2.
  6. 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.
  7. Has received psychotherapy or behavioral treatments within 30 days of screening, or during the study.
  8. Taking antidepressants or psychoactive medications (e.g., antipsychotics, antidepressants, benzodiazepines, hypnotics).
  9. Use of any of these products in the past 30 days:

    1. Illegal drugs (or if the urine drug screen is positive for cocaine, tetrahydrocannabinol (THC), amphetamines, methamphetamines, or opiates);
    2. Experimental () drugs that are unknown to participant;
    3. Chronic opiate use;
    4. Medications to treat tuberculosis (e.g., isoniazid, ethionamide).
  10. 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.
  11. Pregnant or nursing (by self-report) or positive pregnancy test.
Terms in these criteria, in plain language(4)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Informed consent

Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.

You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.

ECG (electrocardiogram)

A recording of the heart’s electrical activity, taken with stickers on the chest, arms and legs. It takes a few minutes and does not hurt.

BMI (body mass index)

Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.

What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.

Investigational drug or device

A drug or device being studied in a clinical trial.

It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.

05

Study design

Phase
Phase 2
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
25 participants (actual)

Study arms

  • Experimental
    DCS with Juul e-cigarette

    d-cycloserine (DCS) 100 mg taken orally, once a day for six weeks. There will be a 50 mg dose taken the afternoon/evening prior to the first switch date (after enrollment) to ensure serum levels of the medication are available for the first switch to e-cigarette attempt. Participants will be instructed to use the Juul as often as they like during the 12 week period, and to switch completely to the Juul within 1 week. If, however, they do smoke any combustible cigarettes (CC), they will also be instructed to use the Juul immediately before each CC 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 CCs by the end of the first week of use.

    Drug: d-cycloserine · Other: Juul e-cigarette

Interventions

  • d-cycloserine (DCS) 100 mg taken orally, once a day for six weeks.

  • OtherJuul e-cigarette

    Juul use as often as the participant likes for 12 weeks.

06

What researchers measure

Primary outcomes

  1. Smoking Abstinence based on Self-Report

    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.

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

  2. Smoking Abstinence based on Expired Air Carbon Monoxide (CO)

    Complete switching from combustible cigarette use at each time point will be confirmed by an expired air CO reading of less than 5 ppm.

    Time frame: End of Week 6, End of Week 12

Secondary outcomes

  1. Reduction in Cigarettes Per Day

    Reduction in the number of reports cigarettes smoked per day over the previous seven days (at each time point) compared to baseline.

    Time frame: Week 6, Week 12, Six-Month Follow-Up

  2. Reduction in Expired Air Carbon Monoxide (CO)

    Reduction in Expired Air Carbon Monoxide (CO) compared to baseline.

    Time frame: End of Week 6, End of Week 12

  3. Change in rewarding effects for cigarettes and e-cigarettes at 6 weeks post switch

    o assess subjective satisfaction and other perceived rewarding or aversive effects accompanying e-cigarette use and combustible cigarette use using the modified (e-Cigarette) Cigarette Evaluation Questionnaire. This questionnaire contains five subscale scores: smoking satisfaction (satisfying, tastes good, enjoy smoking), psychological rewards (calms down, more awake, less irritable, helps concentrate, reduces hunger), aversion (dizziness, nauseated), enjoyment of respiratory tract sensations (single-item assessment), craving reduction (single-item assessment). Participants will be asked to assess the 12 items of the questionnaire on a 7-point scale, ranging from "1-not at all" to "7-extremely".

    Time frame: End of Week 6

Other outcomes

  1. Tolerability of daily use of D-cycloserine in conjunction with Juul

    The frequency and severity of adverse events will be tabulated as well as the likelihood of their causal relationship to treatment.

    Time frame: Week 2, Week 6, Week 8, Week 12

07

Study locations

2 sites
  • Rose Research Center
    Charlotte, North Carolina 28262, United States
  • Rose Research Center
    Raleigh, North Carolina 27617, United States
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jan 20, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT05994703
Lead sponsor
Rose Research Center, LLC
Collaborators
Foundation for a Smoke Free World INC
Responsible party
Sponsor
First posted
Aug 16, 2023
Start date
Oct 20, 2023
Primary completion
Oct 13, 2025
Completion
Jan 12, 2026
Last update
Jan 20, 2026

Oversight

Data monitoring committee
No
FDA-regulated drug
Yes
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in Jan 2026. You cannot join it, but the record below documents what was studied.

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Studies of the drug tested here: Cycloserine

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