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

Smoking Cessation Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05994703
• Other study ID #: CYCLE
• Status: Recruiting
• Phase: Phase 2
• Start date: October 20, 2023
• Est. completion date: June 30, 2024

Study information

• Verified date: October 2023
• Source: Rose Research Center, LLC
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 25
• Est. completion date: June 30, 2024
• Est. primary completion date: February 28, 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 22 Years to 65 Years

Eligibility

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.

Related Conditions & MeSH terms

• Harm Reduction
• Smoking Cessation

Intervention

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

Other:
• Juul e-cigarette
Juul use as often as the participant likes for 12 weeks.

Locations

Country	Name	City	State
United States	Rose Research Center	Charlotte	North Carolina
United States	Rose Research Center	Raleigh	North Carolina

Sponsors (2)

Lead Sponsor	Collaborator
Rose Research Center, LLC	Foundation for a Smoke Free World INC

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	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.	Week 2, Week 6, Week 8, Week 12
Primary	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.	During weeks 3-6 and 9-12 post-switching date.
Primary	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.	End of Week 6, End of Week 12
Secondary	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.	Week 6, Week 12, Six-Month Follow-Up
Secondary	Reduction in Expired Air Carbon Monoxide (CO)	Reduction in Expired Air Carbon Monoxide (CO) compared to baseline.	End of Week 6, End of Week 12
Secondary	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".	End of Week 6