Nicotine Regulation for Tobacco Use Disorder
(RDEC Trial)
Trial Summary
What is the purpose of this trial?
Cigarette smoking remains the leading cause of preventable morbidity and mortality in the US. Use of multiple tobacco products is becoming increasingly prevalent, with dual use of e-cigarettes and cigarettes representing the most common combination. Though e-cigarettes are not without risk, completely switching from cigarettes to e-cigarettes likely reduces risk for tobacco-related harm. However, many established dual users maintain long-term smoking and the majority who use e-cigarettes non-daily are at an even greater risk for prolonged smoking than exclusive cigarette smokers. The Food and Drug Administration Center for Tobacco Products (FDA CTP) has announced plans to implement a nicotine-limiting product standard, capping the nicotine in cigarettes at a minimally or non-addictive level. Randomized controlled trials (RCTs) demonstrate that adults who exclusively smoke cigarettes respond to very low nicotine content (VLNC) cigarettes with reductions in smoking, demand, and dependence. However, nicotine reduction RCTs to date have excluded people who regularly use e-cigarettes and therefore it remains unclear how a nicotine-limiting standard for cigarettes would affect smoking among dual users. Given the potential substitutability of e-cigarettes for cigarettes, reducing the nicotine in cigarettes could promote a transition to exclusive e-cigarette use among dual users unable to completely quit nicotine, but only if sufficiently appealing e-cigarettes remain available. E-cigarettes containing 5% nicotine-salt solution are currently most popular in the US, but policy makers have proposed restricting e-cigarettes to ≤ 2% nicotine to curb youth e-cigarette use, and several states have already set limits to reduce nicotine in e-cigarettes. Prior laboratory studies indicate that higher vs lower nicotine e-cigarettes serve as better substitutes for cigarettes among adult dual users. As such, a restriction on e-cigarette nicotine concentration could undermine the potential for e-cigarettes to substitute for cigarettes and diminish the benefits of a nicotine-limiting standard for cigarettes among dual users. This study is a 12-week double-blind 2 cigarette level (Normal Nicotine vs Very Low Nicotine) x 2 e-cigarette level (High Nicotine vs Low Nicotine) between-subjects factorial trial to investigate how a nicotine-limiting standard for cigarettes affects adult dual users and whether these effects are impacted by constraints on e-cigarette nicotine concentration. Outcome measures include cigarettes per day, cigarette dependence, and toxicant exposure. The research is highly relevant to FDA CTP domains of Addiction and Behavior because it will test whether reducing the nicotine content of cigarettes reduces smoking and dependence, and whether these effects are moderated by the availability of high vs low nicotine e-cigarettes.
Will I have to stop taking my current medications?
The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the study team or your doctor.
What data supports the effectiveness of the treatment Nicotine Regulation for Tobacco Use Disorder?
Research shows that Nicotine Replacement Therapy (NRT), which is part of Nicotine Regulation, helps people quit smoking by reducing the number of cigarettes smoked and increasing motivation to quit. Studies also indicate that using NRT during hospital stays can be a good opportunity to encourage quitting.12345
Is nicotine replacement therapy generally safe for humans?
Nicotine replacement therapy (NRT) is generally considered safe for humans, although some people may experience side effects, especially if nicotine levels become too high. Studies have shown that while NRT is effective in helping people quit smoking, monitoring for potential neuropsychiatric and cardiovascular risks is important.678910
How is Nicotine Regulation different from other treatments for tobacco use disorder?
Nicotine Regulation, also known as Nicotine Replacement Therapy, is unique because it involves using various forms of nicotine delivery, like patches, gum, or sprays, to gradually reduce dependence on tobacco. Unlike other treatments, it focuses on managing nicotine levels to reduce addiction without the harmful effects of smoking.311121314
Research Team
Elias Klemperer, PhD
Principal Investigator
University of Vermont
Eligibility Criteria
This trial is for adult smokers who regularly use both e-cigarettes and traditional cigarettes. Participants should be dual users to understand how varying nicotine levels in these products impact their smoking habits and dependence.Inclusion Criteria
Exclusion Criteria
Timeline
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants are assigned to one of four groups to receive either normal or very low nicotine cigarettes and high or low nicotine e-cigarettes for 12 weeks
Follow-up
Participants are monitored for safety and effectiveness after treatment, including measures of cigarettes per day, cigarette dependence, and toxicant exposure
Treatment Details
Interventions
- Nicotine Regulation
Nicotine Regulation is already approved in European Union, United States, Canada for the following indications:
- Smoking cessation
- Nicotine addiction
- Smoking cessation
- Tobacco-related harm reduction
- Smoking cessation
- Nicotine addiction management
Find a Clinic Near You
Who Is Running the Clinical Trial?
University of Vermont
Lead Sponsor