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Electronic Cigarette
Very Low Nicotine Cigarettes + E-Cigarettes for Smoking Cessation
N/A
Waitlist Available
Led By Paul Cinciripini
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
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 10 weeks
Awards & highlights
Study Summary
This trial is testing how different levels of nicotine in cigarettes and e-cigarettes affects smokers trying to quit. They're looking at things like withdrawal symptoms, cravings, and mood to see how easy it is to quit smoking.
Who is the study for?
This trial is for daily and intermittent cigarette smokers who are interested in trying novel nicotine products. Participants must be able to follow instructions in English, have only one person per household join, and can receive mail and do telehealth visits. They cannot use other e-cigarettes or smoking cessation meds recently, have severe respiratory issues, unstable medical conditions, certain mental health diagnoses, or be pregnant/breastfeeding without birth control.Check my eligibility
What is being tested?
The study tests the effects of greatly reduced nicotine levels in cigarettes versus electronic cigarettes with varying nicotine content on smoker behavior. It aims to see how these changes affect withdrawal symptoms, cravings for nicotine, mood swings, and overall smoking habits among current smokers.See study design
What are the potential side effects?
While not explicitly listed here, potential side effects may include typical reactions to reducing nicotine intake such as increased cravings for tobacco products; irritability; difficulty concentrating; sleep disturbances; increased appetite leading to weight gain; and possible dependence on the e-cigarette products provided.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ up to 10 weeks
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 10 weeks
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
To characterize the effects of switching to VLNCCs plus ECIG-Hi or ECIG-Lo nicotine doses on abuse liability among daily and intermittent smokers.
Trial Design
2Treatment groups
Experimental Treatment
Group I: Arm II (usual cigarettes, VLNCC, ECIG-Hi, ECIG-Lo)Experimental Treatment7 Interventions
PHASE I: Patients smoke their usual cigarettes brand during week 1.
PHASE II: Patients smoke VLNCC cigarettes provided during weeks 2-4.
PHASES III-IV: Patients smoke ECIG-Lo for 3 weeks and then ECIG-Hi for 3 weeks.
Group II: Arm I (usual cigarettes, VLNCC, ECIG-Hi, ECIG-Lo)Experimental Treatment7 Interventions
PHASE I: Patients smoke their usual cigarettes brand during week 1.
PHASE II: Patients smoke VLNCC cigarettes provided during weeks 2-4.
PHASES III-IV: Patients smoke ECIG-Hi for 3 weeks and then ECIG-Lo for 3 weeks.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Cigarette
2017
Completed Phase 1
~310
Nicotine Replacement
2019
Completed Phase 2
~420
Find a Location
Who is running the clinical trial?
M.D. Anderson Cancer CenterLead Sponsor
2,966 Previous Clinical Trials
1,804,401 Total Patients Enrolled
National Institute on Drug Abuse (NIDA)NIH
2,464 Previous Clinical Trials
2,618,213 Total Patients Enrolled
Paul CinciripiniPrincipal InvestigatorM.D. Anderson Cancer Center
3 Previous Clinical Trials
2,641 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I have recently quit smoking, am trying to quit, or plan to quit within 45 days.I am not pregnant, post-menopausal for two years, or have had surgery to prevent pregnancy.I am using a reliable birth control method if I can become pregnant.I have used smoking cessation aids in the last 90 days.I have had heart issues like abnormal rhythms or a heart attack in the last 3 months.I have used tobacco products other than cigarettes or little cigars on 10 or more days in the last month.I am mentally and physically able to participate in the entire study.I have taken medication for depression, like amitriptyline, in the last 2 weeks.I haven't had a lung infection in the last 2 weeks.I smoke 1 or more cigarettes some days each month, but not daily.I agree not to be in a vehicle during study procedures or talks.
Research Study Groups:
This trial has the following groups:- Group 1: Arm I (usual cigarettes, VLNCC, ECIG-Hi, ECIG-Lo)
- Group 2: Arm II (usual cigarettes, VLNCC, ECIG-Hi, ECIG-Lo)
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.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
How many participants are being recruited for this investigation?
"This trial is no longer open for enrolment, having first been posted on October 26th 2017 and last updated September 2nd 2022. However, if you're still searching for trials to get involved in there are presently 2490 studies related to cigarette smoking-related carcinoma and 71 clinical trials actively seeking participants with Cigarette addiction."
Answered by AI
Are there any vacancies still open to join this research program?
"Unfortunately, this specific clinical trial is no longer recruiting. It was initially posted on October 26th 2017 and had its last update made on September 2nd 2022. However, there are currently 2490 trials searching for participants with cigarette smoking-related carcinoma and 71 trials actively looking to recruit individuals using cigarettes available as alternatives to consider."
Answered by AI
Can you tell me about other research projects which have explored the effects of Cigarette?
"At present, 71 live clinical trials examining Cigarette are active with 5 of them in Phase 3. Several of these scientific experiments have been commissioned in Green Bay, Wisconsin while the remaining 204 locations can be found throughout the country."
Answered by AI
Is this research study offering participation to individuals over the age of seventy?
"As indicated by the criteria for inclusion in this trial, applicants must be between 21 and 65 years old."
Answered by AI
Who else is applying?
What state do they live in?
Texas
What site did they apply to?
M D Anderson Cancer Center
What portion of applicants met pre-screening criteria?
Met criteria
How many prior treatments have patients received?
0
How responsive is this trial?
Most responsive sites:
- M D Anderson Cancer Center: < 48 hours
Average response time
- < 2 Days
Typically responds via
Phone Call
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