权益分类	功能权益	普通用户	{{item.name}}会员
{{category.name}}	{{benefitItem.name}}

A clinical trial of adaptive treatment for early smoking cessation relapse

早期戒烟复发适应性治疗的临床试验

基本信息

批准号：
10752773
负责人：
Matthew J Carpenter
金额：
$ 62.21万
依托单位：
MEDICAL UNIVERSITY OF SOUTH CAROLINA
依托单位国家：
美国
项目类别：
财政年份：
2023
资助国家：
美国
起止时间：
2023-07-01 至 2028-06-30
项目状态：
未结题

来源：
https://reporter.nih.gov/project-details/10752773
关键词：
Abstinence Adult Alabama Biochemical Centers for Disease Control and Prevention (U.S.)Cigarette Cigarette Smoker Clinical Trials Communities Coping Skills Data Decision Making Dependence Early treatment Electronic cigarette FDA approved Failure Frequencies Frustration Goals Guidelines Harm Reduction Health Benefit Health Personnel Individual Instruction Intervention Learning Skill Measures Methodology Methods Modality Nicotine Oral Outcome Participant Pharmaceutical Preparations Pharmacotherapy Positioning Attribute Prevalence Randomized Recommendation Relapse Research Research Personnel Seasons Selection Bias Selection for Treatments Smoker Smoking Smoking Cessation Intervention Smoking treatment South Carolina Testing Time Tobacco behavior change clinical decision-making clinical practice clinically relevant design evidence base exhaust experience follow-up innovation interest nicotine patch nicotine replacement non-smoking pharmacologic preempt randomized, clinical trials recruit remote delivery secondary outcome skill acquisition smoking abstinence smoking cessation success tobacco products treatment responders treatment trial varenicline

项目摘要

Abstract Most smokers want to quit smoking, and most smokers try to quit smoking each year. Yet, most attempts to quit smoking fail. FDA-approved pharmacotherapies can help, but non-response, either through relapse or through inability to initiate cessation, is still the most common outcome. Despite the frequency of treatment non-response, few trials have investigated the best path forward for treatment in these instances—should smokers try to quit again with the same pharmacotherapy, consistent with package guidelines to continue with treatment for 12 weeks, or should early failure be preempted and met with a change in pharmacotherapy? Further, for smokers who have tried to quit with pharmacotherapy multiple times and are still smoking, is it better to switch to a less harmful tobacco product rather than trying to quit repeatedly with FDA-approved pharmacotherapy? The proposed adaptive treatment trial will test whether 1) switching between pharmacotherapies following an initial failure better promotes abstinence than a repeated attempt with the same pharmacotherapy, and 2) whether switching to e-cigarettes following successive failures with multiple pharmacotherapies better promotes abstinence from cigarettes than a third attempt to quit with the same course of pharmacotherapy. Daily smokers across South Carolina and Alabama who are willing to set a quit date (N=544) will be provided with a 4-week supply of FDA approved smoking-cessation medication and provided with instructions to set a date and to quit smoking completely. First-course medication will be either combination nicotine replacement therapy (transdermal nicotine patch and oral nicotine lozenge) or varenicline, counterbalanced. After four weeks of treatment, those who have not responded to initial treatment (i.e., non-responders) will be assigned in a 2:1 fashion to either Adaptive Treatment (medication switch) or Non-Adaptive Treatment (medication continuance; Aim 1). After a second four weeks of treatment, non-responders will be assigned in a 2:1 fashion to either a Harm Reduction Approach (to switch to a less harmful tobacco product; e-cigarettes) or Non-Adaptive Treatment (medication continuance; Aim 2), again with instructions to switch or quit completely. Outcomes include biochemically-confirmed 7-day abstinence from smoking, smoking reduction, measures of dependence, duration of abstinence, and dual use, each measured at key intervention timepoints: after each course of treatment, with follow-up through six months. This innovative R01 application is led by two seasoned investigators with expertise in smoking cessation, harm reduction, and remote clinical trials. The research question is highly significant and is positioned to provide strong, data-driven guidance on treatment decision making for the most common problem facing even the best treatments for smoking: failure. Trial results provide a significant opportunity to optimize cessation outcomes for smokers who continue to struggle in quitting.

摘要