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Very Low Nicotine Cigarettes for Tobacco Use Disorder
Study Summary
This trial will study if smokers who switch to cigarettes with very low nicotine content will have changes in the brain circuits involved in craving and self-control.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowTimeline
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Side effects data
From 2019 Phase 1 & 2 trial • 775 Patients • NCT02232737Trial Design
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Who is running the clinical trial?
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- You have smoked cigarettes every day for over a year.You have used illegal drugs (except marijuana) more than once a week in the last 3 months.You have a current problem with alcohol that would make it difficult for you to take part in the study.You have a serious brain injury or condition related to your nervous system.You have used medication to quit smoking (like varenicline or patches) in the last month.You smoke more than 5 cigarettes every day.You are left-handed.You must be between 21 and 60 years old.You have not tried to quit smoking in the past month, and you do not plan to quit within the next 3 months.You have used any tobacco product other than cigarettes in the last 7 days.You don't want to smoke the cigarettes given to you for the rest of the study.You have self-reported color blindness.You are not pregnant or breastfeeding, and are using birth control to prevent pregnancy during the study.You have a serious mental illness that is not under control or have been hospitalized for mental health issues in the past 6 months.
- Group 1: Normal nicotine content cigarettes
- Group 2: Very low nicotine content cigarettes
- 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
Are minors authorized to participate in this clinical experimentation?
"As per the restrictions, only persons aged 21 to 60 are eligible for enrollment in this clinical trial."
Is there a possibility for eligible individuals to join this experiment?
"Affirmative. Per information on clinicaltrials.gov, this medical trial is actively recruiting participants; the first listing was made on February 20th 2020 and it has been revised as recently as March 25th 2022. The research team requires a total of 90 individuals to take part in the study from one specific site."
Who may participate in the current clinical exploration?
"This clinical trial is seeking 90 individuals addicted to tobacco, aged between 21 and 60. There are a number of prerequisites for enrolment, such as smoking at least 5 cigarettes daily; residing in the local vicinity for 3 months; 1 year or more of nicotine usage without cessation attempts; comprehending and consenting to research protocols; abstaining from pregnancy/nursing via contraception measures; access to an internet-enabled computer with Zoom capabilities; having no higher than high school education or earning less than $50k annually. In addition, applicants must not have attempted quitting within 1 month prior nor plan on doing so over the following 3 months"
What is the capacity of enrollment in this clinical trial?
"Affirmative. The clinical trial, which was initially advertised on February 20th 2020, is still recruiting patients as per the information hosted on clinicaltrials.gov and last updated on March 25th 2022. They are looking for 90 participants to enroll at one location."
What other experimentations have been conducted using Very low nicotine content cigarettes?
"As of now, 71 clinical trials for Very low nicotine content cigarettes are being conducted. Of those, 5 have reached the third phase of study. The majority of these research sites are based in Greenville, South carolina; however there is a total number of 204 locations managing experiments related to this treatment."
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