COMPLETED

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

Conditions

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

Official Title

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

Quick Facts

Study Start:2023-10-20

Study Completion:2026-01-12

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:COMPLETED

Study ID

NCT05994703

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:22 Years to 65 Years

Sexes Eligible for Study:ALL

Accepts Healthy Volunteers:Yes

Standard Ages:ADULT, OLDER_ADULT

Inclusion Criteria	Exclusion 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.	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.

Inclusion Criteria

Exclusion 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.

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.

Contacts and Locations

Study Locations (Sites)

Rose Research Center

Charlotte, North Carolina, 28262

United States

Rose Research Center

Raleigh, North Carolina, 27617

United States

Collaborators and Investigators

Sponsor: Rose Research Center, LLC

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2023-10-20

Study Completion Date2026-01-12

Study Record Updates

Study Start Date2023-10-20

Study Completion Date2026-01-12

Terms related to this study

Additional Relevant MeSH Terms

Smoking Cessation
Harm Reduction