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Anti-metabolites

D-cycloserine + E-Cigarette for Smoking Cessation

Phase 2

Recruiting

Research Sponsored by Rose Research Center, LLC

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Be older than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up week 6, week 12, six-month follow-up

Awards & highlights

Study Summary

This trial will see if combining reward devaluation and a medication can help smokers switch to Juul from cigarettes.

Who is the study for?

This trial is for smokers aged 22-65 who smoke more than 10 cigarettes a day and want to switch to an e-cigarette. They must have a compatible smartphone, breathe out enough carbon monoxide, and agree to the study's rules. People with serious health issues, high depression scores, plans to use other quit-smoking aids, certain heart conditions or drug uses can't join.Check my eligibility

What is being tested?

The study tests if taking d-cycloserine helps smokers switch from regular cigarettes to Juul e-cigarettes better than without it. It builds on previous research about changing rewards linked with smoking habits.See study design

What are the potential side effects?

D-cycloserine may cause side effects like nervousness, trouble sleeping, or headaches. Using Juul e-cigarettes instead of smoking could lead to nicotine withdrawal symptoms such as irritability or cravings.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ week 6, week 12, six-month follow-up

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~week 6, week 12, six-month follow-up

This trial's timeline: 3 weeks for screening, Varies for treatment, and week 6, week 12, six-month follow-up for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Smoking Abstinence based on Expired Air Carbon Monoxide (CO)

Smoking Abstinence based on Self-Report

Secondary outcome measures

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

Reduction in Cigarettes Per Day

Reduction in Expired Air Carbon Monoxide (CO)

Other outcome measures

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

Trial Design

1Treatment groups

Experimental Treatment

Group I: DCS with Juul e-cigaretteExperimental Treatment2 Interventions

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.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

d-cycloserine

2018

Completed Phase 4

~630

Do I qualify?Apply below to find out

Find a Location

Who is running the clinical trial?

Rose Research Center, LLCLead Sponsor

15 Previous Clinical Trials

1,432 Total Patients Enrolled

Foundation for a Smoke Free World INCOTHER

14 Previous Clinical Trials

2,124 Total Patients Enrolled

Media Library

D-cycloserine (Anti-metabolites) Clinical Trial Eligibility Overview. Trial Name: NCT05994703 — Phase 2

Smoking Cessation Research Study Groups: DCS with Juul e-cigarette

Smoking Cessation Clinical Trial 2023: D-cycloserine Highlights & Side Effects. Trial Name: NCT05994703 — Phase 2

D-cycloserine (Anti-metabolites) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05994703 — Phase 2

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Does this research experiment allow elderly individuals aged 70 and above to participate?

"If you satisfy the age requirement of being between 22 and 65, then you are eligible for this clinical trial. Alternatively, there are 8 trials available to those younger than 18 years old and 136 studies open to seniors above 65."

Answered by AI

Does this experiment still accept volunteers?

"The clinicaltrials.gov website reveals that this particular medical study is not presently enrolling patients. In the past, it was posted on September 1st 2023 and last edited 8th August 2023; however, there are 149 other trials currently recruiting participants."

Answered by AI

Could I potentially partake in this experiment?

"To be a suitable candidate for this clinical trial, one must have quit smoking and be between 22-65 years old. The study is seeking to enroll approximately 25 participants."

Answered by AI

Could you please explain the potential dangers of diacetyl inhalation with Juul e-cigarette usage?

"Based on our evaluation, DCS with Juul e-cigarette was rated a 2 because there are some safety data available while efficacy has yet to be determined in clinical trials."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

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

2023. "Assisting Smokers to Switch to an e-Cigarette by Accelerating Learning of Adaptive Habits Using D-cycloserine". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05994703.