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Electronic Cigarette

Switching to E-Cigarettes for Smoking Reduction

N/A
Recruiting
Led By Jason Robinson
Research Sponsored by M.D. Anderson Cancer Center
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Willing and able to complete 2 spirometry sessions
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up all in-person sessions (weeks 0, 2, 4, and 6)
Awards & highlights

Study Summary

This trial will study potential differences between men and women when switching from regular cigarettes to electronic cigarettes.

Who is the study for?
This trial is for adult smokers who've been smoking at least 5 cigarettes daily for the past month, have a stable address and phone, can follow instructions in English, and are willing to switch to tobacco-flavored e-cigarettes. Pregnant or breastfeeding women, those not using birth control, people with severe lung obstruction or unstable health conditions like uncontrolled diabetes or hypertension cannot join.Check my eligibility
What is being tested?
The study aims to understand gender differences when switching from regular cigarettes to electronic ones provided by the research team. Participants will use these e-cigarettes and complete questionnaires while their lung function is tested twice during the study.See study design
What are the potential side effects?
Potential side effects may include nicotine withdrawal symptoms such as cravings, irritability, difficulty concentrating, increased appetite and weight gain. E-cigarette use might also cause throat irritation or coughing.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
Select...
I can complete 2 breathing test sessions.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~all in-person sessions (weeks 0, 2, 4, and 6)
This trial's timeline: 3 weeks for screening, Varies for treatment, and all in-person sessions (weeks 0, 2, 4, and 6) for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Cigarettes per day (CPD) (Aim 1)
Differences between male or female smokers (Aim 2)
Secondary outcome measures
Brief Smoking Consequences Questionnaire-Adult (BSCQ-A)
Change in E-cigarette specific Brief Smoking Consequences Questionnaire-Adult (EC-BSCQ-A)
Change in Expired carbon monoxide (CO)
+13 more
Other outcome measures
Moderators and mediators of switching to e-cigarettes (with and without nicotine) from regular cigarettes (Exploratory Aim)

Trial Design

2Treatment groups
Experimental Treatment
Group I: E-Cig placebo dose followed by E-Cig nicotine doseExperimental Treatment3 Interventions
Participants will be instructed to smoke their usual brand cigarette as they normally would in weeks 1-2 (Phase I) and to use only the SREC (with or without nicotine) in weeks 3-4 (Phase II) and in weeks 5-6 (Phase III). Participant assignment to SREC type at Phases II and III will be counter-balanced within group, with half of men and women receiving the placebo SREC during Phase II and half during Phase III. Participants will attend 4 laboratory visits with study investigators for 3 hours each over 6 weeks of study participation.
Group II: E-Cig nicotine dose followed by E-Cig placebo doseExperimental Treatment3 Interventions
Participants will be instructed to smoke their usual brand cigarette as they normally would in weeks 1-2 (Phase I) and to use only the SREC (with or without nicotine) in weeks 3-4 (Phase II) and in weeks 5-6 (Phase III). Participant assignment to SREC type at Phases II and III will be counter-balanced within group, with half of men and women receiving the placebo SREC during Phase II and half during Phase III. Participants will attend 4 laboratory visits with study investigators for 3 hours each over 6 weeks of study participation.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Nicotine Replacement
2019
Completed Phase 2
~420
Electronic Cigarette
2012
N/A
~1050

Find a Location

Who is running the clinical trial?

National Institute on Drug Abuse (NIDA)NIH
2,468 Previous Clinical Trials
2,619,152 Total Patients Enrolled
M.D. Anderson Cancer CenterLead Sponsor
2,972 Previous Clinical Trials
1,787,121 Total Patients Enrolled
Jason RobinsonPrincipal InvestigatorM.D. Anderson Cancer Center
1 Previous Clinical Trials
311 Total Patients Enrolled

Media Library

Electronic Cigarette (Electronic Cigarette) Clinical Trial Eligibility Overview. Trial Name: NCT03856515 — N/A
Cancer Research Study Groups: E-Cig placebo dose followed by E-Cig nicotine dose, E-Cig nicotine dose followed by E-Cig placebo dose
Cancer Clinical Trial 2023: Electronic Cigarette Highlights & Side Effects. Trial Name: NCT03856515 — N/A
Electronic Cigarette (Electronic Cigarette) 2023 Treatment Timeline for Medical Study. Trial Name: NCT03856515 — N/A
Cancer Patient Testimony for trial: Trial Name: NCT03856515 — N/A

Frequently Asked Questions

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

What is the total number of participants for this clinical research?

"Affirmative. Per the clinicaltrials.gov website, this research is still enrolling patients who meet eligibility requirements. It was initially published on June 2nd 2022 and its most recent revision took place on November 11th of that same year; 164 individuals are needed to participate at a single site."

Answered by AI

Is the current enrollment period for this experiment open?

"The clinical trial is currently seeking participants. Initially posted on June 2nd 2022, the protocol was most recently amended November 11th 2022 according to clinicaltrials.gov data."

Answered by AI

What objectives is this research attempting to achieve?

"The objective of this short-term clinical trial is to compare male and female smokers. Secondary endpoints include measuring expired carbon monoxide (CO) with the Micro Pro-Smokerlyzer, completing a demographics survey involving smoking habits, tobacco product use, and health history questionnaires, as well as tracking Standard Research E-Cigarette (SREC) consumption through Time Line Follow Back (TLFB)."

Answered by AI

What other investigations have been conducted with respect to Nicotine Replacement?

"At present, 71 clinical studies on Nicotine Replacement are being conducted with 5 trials in the final phase. Most of these occur near Greenville, South carolina but there are 204 total locations where research is taking place."

Answered by AI

Who else is applying?

What state do they live in?
Texas
How old are they?
18 - 65
What site did they apply to?
M D Anderson Cancer Center
What portion of applicants met pre-screening criteria?
Did not meet criteria
Met criteria
How many prior treatments have patients received?
3+
2
0

Why did patients apply to this trial?

My grandkids and my health. This is my way of helping others. Looking to quit smoking cigarettes.
PatientReceived 2+ prior treatments
I have only tried Snus to help me quit. I have tried to quit smoking on my own but that hasn't worked.
PatientReceived 1 prior treatment

How responsive is this trial?

Typically responds via
Email
Most responsive sites:
  1. M D Anderson Cancer Center: < 24 hours
Average response time
  • < 2 Days
Recent research and studies
clinicaltrials.govStudy
Gender Differences in Switching From Smoking Regular Cigarettes to E-Cigarettes
2022. "Gender Differences in Switching From Smoking Regular Cigarettes to E-Cigarettes". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT03856515.
All > Smoking
~30 spots leftby Aug 2024
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