Ignite Creation Date:
2024-10-26 @ 3:41 PM
Last Modification Date:
2024-10-26 @ 3:41 PM
Study NCT ID:
NCT06614504
Status:
NOT_YET_RECRUITING
Last Update Posted:
None
First Post:
2024-09-23
Brief Title:
Nicotine Regulation for Dual Users of E-cigarettes and Cigarettes
Sponsor:
None
Organization:
None
Study Overview
Official Title:
A Randomized Controlled Trial of Reduced Nicotine Cigarettes and E-cigarettes Among Dual Users
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-09
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
RDEC
Brief Summary:
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
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None