Helping smokers switch to e-cigarettes using a medication
Assisting Smokers to Switch to an e-Cigarette by Accelerating Learning of Adaptive Habits Using D-cycloserine
PHASE2 · Rose Research Center, LLC · NCT05994703
This study is testing whether a combination of a medication and rewards can help smokers switch from regular cigarettes to e-cigarettes like Juul and quit smoking altogether.
Quick facts
| Phase | PHASE2 |
|---|---|
| Study type | Interventional |
| Enrollment | 25 (estimated) |
| Ages | 22 Years to 65 Years |
| Sex | All |
| Sponsor | Rose Research Center, LLC (industry) |
| Locations | 2 sites (Charlotte, North Carolina and 1 other locations) |
| Trial ID | NCT05994703 on ClinicalTrials.gov |
What this trial studies
This study evaluates a method to assist smokers in transitioning from combustible cigarettes to e-cigarettes, specifically Juul, by employing a reward devaluation strategy combined with the medication d-cycloserine. Participants will be monitored for their ability to adapt to this change and the effectiveness of the intervention in promoting smoking cessation. The study aims to gather data on the impact of this combined approach on smoking habits and cessation rates.
Who should consider this trial
Good fit: Ideal candidates are adults aged 22 to 65 who smoke at least 10 cigarettes per day and are interested in switching to e-cigarettes.
Not a fit: Patients with significant health issues or those unable to participate for medical, psychiatric, or social reasons may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could significantly aid smokers in quitting combustible cigarettes, potentially reducing health risks associated with smoking.
How similar studies have performed: Previous studies have explored similar reward devaluation strategies, but the combination with d-cycloserine in this context is relatively novel.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria:
1. Has signed the informed consent 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:
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, ECG, 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. Body mass index (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 (investigational) 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.
Where this trial is running
Charlotte, North Carolina and 1 other locations
- Rose Research Center — Charlotte, North Carolina, United States (RECRUITING)
- Rose Research Center — Raleigh, North Carolina, United States (RECRUITING)
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Smoking Cessation, Harm Reduction