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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
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
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
Eligibility Criteria:
This trial includes the following eligibility criteria:- I have a history of heart problems, including heart disease or heart attack.I have not used illegal or experimental drugs, chronic opiates, or TB medications in the last 30 days.I have been smoking 10 or more cigarettes daily for the past year.I haven't used any tobacco products or smoking cessation aids in the last 14 days.I am between 22 and 65 years old.I plan to use an FDA-approved product to quit smoking during the study.I am currently taking antidepressants or medications for my mental health.I have undergone psychotherapy or behavioral treatments recently.
Research Study Groups:
This trial has the following groups:- Group 1: DCS with Juul e-cigarette
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
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