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

Launched by ROSE RESEARCH CENTER, LLC · Aug 8, 2023

Keywords

ClinConnect Summary

This clinical trial is looking at a new way to help people quit smoking by encouraging them to switch from traditional cigarettes to e-cigarettes, specifically a brand called Juul. Researchers want to see if a combination of a special medication called d-cycloserine and a method that helps change how people think about smoking rewards can make this switch easier. The study is currently seeking participants aged 22 to 65 who smoke at least 10 cigarettes a day and are interested in making the change to e-cigarettes.

To participate, you would need to agree to the study details, own a smartphone for surveys, and meet certain health criteria. You wouldn't be able to join if you have specific health conditions, are taking certain medications, or have used other smoking cessation products recently. If eligible, participants can expect to receive support throughout the study to help them transition away from traditional smoking. This study could be an important step in understanding how to help smokers reduce harm and improve their health.

Gender

ALL

Eligibility 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.