Repurposing Melatonin Receptor Agonists as Adjunct Treatments for Smoking Cessation
重新利用褪黑激素受体激动剂作为戒烟的辅助治疗
基本信息
- 批准号:9144346
- 负责人:
- 金额:$ 23.76万
- 依托单位:
- 依托单位国家:美国
- 项目类别:
- 财政年份:2015
- 资助国家:美国
- 起止时间:2015-09-15 至 2018-08-31
- 项目状态:已结题
- 来源:
- 关键词:AbstinenceAddressAgonistAttenuatedCarbon MonoxideClinical TrialsConstipationCoupledCrossover DesignDataDevelopmentFDA approvedFemaleFoundationsFutureHeadacheHealthHumanIncentivesIndividualIndividual DifferencesInterventionLaboratoriesLeadMarketingMeasuresMelatonin ReceptorsMental DepressionModelingMoodsNicotine DependenceNicotine WithdrawalOutcomePatient Self-ReportPharmaceutical PreparationsPharmacological TreatmentPharmacotherapyPhasePhysical DependencePlacebo ControlPlacebosPopulationProceduresPropertyRebound InsomniaRecording of previous eventsRelapseResearchResearch DesignResidual stateRiskSafetySamplingSignal TransductionSleepSleep DisordersSleep disturbancesSleeplessnessSmokerSmokingStagingStudy SubjectSymptomsTestingTherapeuticWithdrawalWithdrawal SymptomWithholding Treatmentbasecritical perioddiariesdrug developmentexperiencefallsgender differenceimprovedindexinginnovationnegative moodnicotine patchnicotine replacementnovelnovel strategiesprimary outcomescreeningsleep onsetsmoking cessationsmoking relapsesuccesstherapeutic targettreatment effectvarenicline
项目摘要
DESCRIPTION (provided by applicant): Even with the use of FDA-approved pharmacotherapies for smoking cessation, most smokers relapse within the first few days following a quit attempt. Thus, there is a need to identify novel approaches to optimize treatment to help more smokers maintain abstinence during this critical period. Evidence indicates that sleep disturbance during nicotine withdrawal may be an important, yet overlooked smoking cessation treatment target. This is particularly important since existing treatments do not mitigate withdrawal-related sleep disturbance. Critically, difficulty sleeping is predictive of smoking relapse. In this proof-of-concept study, we hypothesize that the FDA-approved melatonin receptor agonist, ramelteon, in combination with transdermal nicotine replacement therapy (TN), will promote smoking cessation by attenuating sleep disturbance during nicotine withdrawal. Using a well-validated medication screening paradigm, we propose a within-subject, placebo-controlled crossover design with one within-subjects factor of short-term medication (ramelteon vs. placebo). Fifty treatment-seeking smokers will complete this 6-week study, which consists of two 2-week phases separated by a 2-week washout. Each phase includes 1 week of ad libitum smoking (baseline) and 1 week of medication (8mg ramelteon or placebo) plus TN while trying to abstain (quit assessment). Smokers will be provided small monetary incentives for biochemically-confirmed abstinence. Ramelteon's unique properties reduce the likelihood of next-day residual effects, rebound insomnia, and symptoms of physical dependence which render other sleep medications problematic. We have chosen TN because it will be important to address physical nicotine withdrawal symptoms (e.g., headaches, constipation) and it is the most widely used treatment in the U.S. For the duration of the study, subjects will be asked to keep sleep diaries and wear an armband while sleeping which provides objective indices of sleep duration and quality (SensewearPro). All subjects will receive standard TN following completion of the study. The primary outcome will be the total number of days abstinent (out of five), confirmed by carbon monoxide breath sample. This measure is highly predictive of longer-term quit success. Intermediate outcomes will include sleep onset latency (self-report) and sleep efficiency (SensewearPro armband). This innovative line of research will be the first to repurpose a melatonin receptor agonist (ramelteon) to evaluate its effects on withdrawal-related sleep disturbance and short-term quitting success in treatment-seeking smokers. Repurposing medications that have been "de-risked" removes a key barrier to drug development (i.e., safety signals), increasing the likelihood that the drug will be brought to market. Critically, our study design permits exploration of putative mechanisms that underlie the treatment effect. If our hypotheses are supported, these data will lay the foundation for a larger Stage II clinical trial and to extend this adjunct pharmacological treatment to other treatments for smoking cessation.
项目成果
期刊论文数量(0)
专著数量(0)
科研奖励数量(0)
会议论文数量(0)
专利数量(0)
数据更新时间:{{ journalArticles.updateTime }}
{{
item.title }}
{{ item.translation_title }}
- DOI:
{{ item.doi }} - 发表时间:
{{ item.publish_year }} - 期刊:
- 影响因子:{{ item.factor }}
- 作者:
{{ item.authors }} - 通讯作者:
{{ item.author }}
数据更新时间:{{ journalArticles.updateTime }}
{{ item.title }}
- 作者:
{{ item.author }}
数据更新时间:{{ monograph.updateTime }}
{{ item.title }}
- 作者:
{{ item.author }}
数据更新时间:{{ sciAawards.updateTime }}
{{ item.title }}
- 作者:
{{ item.author }}
数据更新时间:{{ conferencePapers.updateTime }}
{{ item.title }}
- 作者:
{{ item.author }}
数据更新时间:{{ patent.updateTime }}
Rebecca Ashare其他文献
Rebecca Ashare的其他文献
{{
item.title }}
{{ item.translation_title }}
- DOI:
{{ item.doi }} - 发表时间:
{{ item.publish_year }} - 期刊:
- 影响因子:{{ item.factor }}
- 作者:
{{ item.authors }} - 通讯作者:
{{ item.author }}
{{ truncateString('Rebecca Ashare', 18)}}的其他基金
Assessing benefits and harms of cannabis use in patients treated with immunotherapy for cancer: a prospective cohort study
评估接受癌症免疫治疗的患者使用大麻的益处和危害:一项前瞻性队列研究
- 批准号:
10792109 - 财政年份:2023
- 资助金额:
$ 23.76万 - 项目类别:
Cannabis use and outcomes in ambulatory patients with cancer: A 12-month cohort study
门诊癌症患者的大麻使用和结果:一项为期 12 个月的队列研究
- 批准号:
10818686 - 财政年份:2022
- 资助金额:
$ 23.76万 - 项目类别:
Cannabis use and outcomes in ambulatory patients with cancer: A 12-month cohort study
门诊癌症患者的大麻使用和结果:一项为期 12 个月的队列研究
- 批准号:
10610465 - 财政年份:2022
- 资助金额:
$ 23.76万 - 项目类别:
Determinants and Outcomes of Nicotine Metabolite Ratio in HIV + Smokers
HIV 吸烟者尼古丁代谢比率的决定因素和结果
- 批准号:
10330407 - 财政年份:2020
- 资助金额:
$ 23.76万 - 项目类别:
Determinants and Outcomes of Nicotine Metabolite Ratio in HIV + Smokers
HIV 吸烟者尼古丁代谢比率的决定因素和结果
- 批准号:
10573496 - 财政年份:2020
- 资助金额:
$ 23.76万 - 项目类别:
Determinants and Outcomes of Nicotine Metabolite Ratio in HIV + Smokers
HIV 吸烟者尼古丁代谢比率的决定因素和结果
- 批准号:
9927113 - 财政年份:2020
- 资助金额:
$ 23.76万 - 项目类别:
Targeting the Cholinergic Pathway in HIV-associated Inflammation and Cognitive Dysfunction
针对 HIV 相关炎症和认知功能障碍的胆碱能通路
- 批准号:
10201539 - 财政年份:2017
- 资助金额:
$ 23.76万 - 项目类别:
Targeting the Cholinergic Pathway in HIV-associated Inflammation and Cognitive Dysfunction
针对 HIV 相关炎症和认知功能障碍的胆碱能通路
- 批准号:
9413656 - 财政年份:2017
- 资助金额:
$ 23.76万 - 项目类别:
Repurposing Melatonin Receptor Agonists as Adjunct Treatments for Smoking Cessation
重新利用褪黑激素受体激动剂作为戒烟的辅助治疗
- 批准号:
9014081 - 财政年份:2015
- 资助金额:
$ 23.76万 - 项目类别:
Repurposing cholinesterase inhibitors for smoking cessation
重新利用胆碱酯酶抑制剂来戒烟
- 批准号:
9233957 - 财政年份:2013
- 资助金额:
$ 23.76万 - 项目类别:
相似海外基金
Rational design of rapidly translatable, highly antigenic and novel recombinant immunogens to address deficiencies of current snakebite treatments
合理设计可快速翻译、高抗原性和新型重组免疫原,以解决当前蛇咬伤治疗的缺陷
- 批准号:
MR/S03398X/2 - 财政年份:2024
- 资助金额:
$ 23.76万 - 项目类别:
Fellowship
Re-thinking drug nanocrystals as highly loaded vectors to address key unmet therapeutic challenges
重新思考药物纳米晶体作为高负载载体以解决关键的未满足的治疗挑战
- 批准号:
EP/Y001486/1 - 财政年份:2024
- 资助金额:
$ 23.76万 - 项目类别:
Research Grant
CAREER: FEAST (Food Ecosystems And circularity for Sustainable Transformation) framework to address Hidden Hunger
职业:FEAST(食品生态系统和可持续转型循环)框架解决隐性饥饿
- 批准号:
2338423 - 财政年份:2024
- 资助金额:
$ 23.76万 - 项目类别:
Continuing Grant
Metrology to address ion suppression in multimodal mass spectrometry imaging with application in oncology
计量学解决多模态质谱成像中的离子抑制问题及其在肿瘤学中的应用
- 批准号:
MR/X03657X/1 - 财政年份:2024
- 资助金额:
$ 23.76万 - 项目类别:
Fellowship
CRII: SHF: A Novel Address Translation Architecture for Virtualized Clouds
CRII:SHF:一种用于虚拟化云的新型地址转换架构
- 批准号:
2348066 - 财政年份:2024
- 资助金额:
$ 23.76万 - 项目类别:
Standard Grant
The Abundance Project: Enhancing Cultural & Green Inclusion in Social Prescribing in Southwest London to Address Ethnic Inequalities in Mental Health
丰富项目:增强文化
- 批准号:
AH/Z505481/1 - 财政年份:2024
- 资助金额:
$ 23.76万 - 项目类别:
Research Grant
ERAMET - Ecosystem for rapid adoption of modelling and simulation METhods to address regulatory needs in the development of orphan and paediatric medicines
ERAMET - 快速采用建模和模拟方法的生态系统,以满足孤儿药和儿科药物开发中的监管需求
- 批准号:
10107647 - 财政年份:2024
- 资助金额:
$ 23.76万 - 项目类别:
EU-Funded
BIORETS: Convergence Research Experiences for Teachers in Synthetic and Systems Biology to Address Challenges in Food, Health, Energy, and Environment
BIORETS:合成和系统生物学教师的融合研究经验,以应对食品、健康、能源和环境方面的挑战
- 批准号:
2341402 - 财政年份:2024
- 资助金额:
$ 23.76万 - 项目类别:
Standard Grant
Ecosystem for rapid adoption of modelling and simulation METhods to address regulatory needs in the development of orphan and paediatric medicines
快速采用建模和模拟方法的生态系统,以满足孤儿药和儿科药物开发中的监管需求
- 批准号:
10106221 - 财政年份:2024
- 资助金额:
$ 23.76万 - 项目类别:
EU-Funded
Recite: Building Research by Communities to Address Inequities through Expression
背诵:社区开展研究,通过表达解决不平等问题
- 批准号:
AH/Z505341/1 - 财政年份:2024
- 资助金额:
$ 23.76万 - 项目类别:
Research Grant