Advancing Varenicline as a Treatment for Cannabis Use Disorder
Advancing Varenicline as a Treatment for Cannabis Use Disorder
批准号:
10202536
负责人:
Kevin M Gray
金额:
$98.17万
依托单位国家:
美国
项目类别:
财政年份:
2016
资助国家:
美国
项目状态:
已结题
起止时间:
2016-09-15 至 2024-07-31
关键词:
AbstinenceAdverse eventAgonistAnteriorBasic ScienceCannabinoidsCannabisClinical TrialsCorpus striatum structureCuesDevelopmentDorsalEvaluationFrequenciesIndividualMeasuresMediatingMemoryNeurocognitionOutcomePatient Self-ReportPharmaceutical PreparationsPharmacodynamicsPharmacotherapyPlacebosPopulationPrefrontal CortexProcessResearchRewardsSafetyShort-Term MemorySystemTestingThalamic structureTobacco Use CessationUnited StatesUrinealcohol abuse therapyalcohol use disorderbaseblood oxygenation level dependent responseclinical effectcognitive enhancementcognitive functioncravingcue reactivitydrug developmentefficacy evaluationfollow-upillicit drug useimprovedmarijuana usemarijuana use disordermesolimbic systemneural circuitneuromechanismreceptorresearch clinical testingrestorationtobacco abstinencevareniclineweek trial
中文摘要
摘要
大麻是美国最常用的非法药物。虽然大麻的使用很普遍,
关于大麻素的基础科学研究已经很发达,药物开发的进展,
大麻使用障碍(CUD)的影响有限。伐尼克兰,一种选择性烟碱nACH受体部分激动剂
α4β2亚型和α7亚型的完全激动剂,可以说是最有效的药物治疗,
促进戒烟,并且还显示出治疗酒精使用障碍的前景。Varenicline
可能通过多种机制改善大麻使用的结果,包括与中脑边缘系统的相互作用
多巴胺系统,增强认知功能,恢复抑制控制。然而,迄今为止,
伐尼克兰尚未在寻求专门治疗CUD的个体中进行评估。在此UG 3/UH 3
应用,我们建议快速而彻底地评估伐尼克兰对CUD的效用,以潜在地促进
通过FDA的药物开发审批渠道。在UG 3组件中,我们将执行
一项为期6周的安慰剂对照的概念验证临床试验,研究伐尼克兰治疗CUD,
大麻线索反应性和抑制控制中涉及的认知功能和神经回路的评价
阐明伐尼克兰作为治疗CUD的药效学。如果UG 3组件的里程碑
UH 3项目将是一项具有充分把握度的12周临床试验,并进行随访,以充分评估
伐尼克兰在该人群中的疗效。
英文摘要
ABSTRACT
Cannabis is the most commonly used illicit drug in the United States. Although cannabis use is widespread and
basic science research on cannabinoids is well-developed, advancements in medication development for
cannabis use disorder (CUD) have been limited. Varenicline, a selective nicotinic nACH receptor partial agonist
of the α4β2 subtype and a full agonist of the α7 subtype, is arguably the most effective pharmacotherapy for
promoting tobacco abstinence, and has also shown promise for the treatment of alcohol use disorder. Varenicline
may improve cannabis use outcomes through multiple mechanisms, including interaction with the mesolimbic
dopamine system, enhancement of cognitive functioning, and restoration of inhibitory control. To date, however,
varenicline has not been evaluated in individuals specifically seeking treatment for CUD. In this UG3/UH3
application, we propose to rapidly yet thoroughly assess the utility of varenicline for CUD to potentially advance
varenicline through the FDA's drug development approval pipeline. In the UG3 component, we will conduct a
six-week, placebo-controlled proof-of-concept clinical trial of varenicline for CUD, paired with pre- and post-
evaluations of cognitive functioning and neural circuitry involved in cannabis cue reactivity and inhibitory control
to elucidate the pharmacodynamics of varenicline as a treatment for CUD. If milestones of the UG3 component
are met, the UH3 project will be an adequately powered 12-week clinical trial with follow-up to fully assess the
efficacy of varenicline in this population.
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会议论文
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批准号:10480914
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资助金额:$62.95万
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财政年份:2018
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负责人:Kevin M Gray
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依托单位:
A Proof-of-Concept Trial of N-Acetylcysteine for Adolescent Alcohol Use Disorder
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批准号:10241372
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资助金额:$72.5万
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财政年份:2018
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A Proof-of-Concept Trial of N-Acetylcysteine for Adolescent Alcohol Use Disorder
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批准号:9789787
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资助金额:$71.23万
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财政年份:2018
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负责人:Kevin M Gray
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依托单位:
13/21 ABCD-USA CONSORTIUM: RESEARCH PROJECT SITE AT MUSC
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批准号:10596593
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项目类别:
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资助金额:$115.03万
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财政年份:2017
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负责人:Kevin M Gray
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依托单位:
N-Acetylcysteine and Contingency Management for Youth Cannabis Use Disorder
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批准号:9156301
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项目类别:
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资助金额:$60.96万
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财政年份:2017
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负责人:Kevin M Gray
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依托单位:
N-Acetylcysteine and Contingency Management for Youth Cannabis Use Disorder
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批准号:10087909
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项目类别:
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资助金额:$51.32万
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财政年份:2017
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负责人:Kevin M Gray
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依托单位:
13/21 ABCD-USA CONSORTIUM: RESEARCH PROJECT SITE AT MUSC
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批准号:9981294
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项目类别:
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资助金额:$118.67万
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财政年份:2017
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负责人:Kevin M Gray
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依托单位:
13/21 ABCD-USA CONSORTIUM: RESEARCH PROJECT SITE AT MUSC
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批准号:10379329
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项目类别:
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资助金额:$115.47万
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财政年份:2017
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负责人:Kevin M Gray
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依托单位:
Advancing Varenicline as a Treatment for Cannabis Use Disorder
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批准号:9249775
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项目类别:
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资助金额:$82.74万
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财政年份:2016
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负责人:Kevin M Gray
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依托单位:
Advancing Varenicline as a Treatment for Cannabis Use Disorder
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批准号:10004604
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项目类别:
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资助金额:$98.17万
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财政年份:2016
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负责人:Kevin M Gray
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依托单位:
Clinical Scientists Training Program in Addictions at MUSC
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批准号:10526608
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项目类别:
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资助金额:$53.44万
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财政年份:2013
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负责人:Kevin M Gray
-
依托单位:
Clinical Scientists Training in Addictions at MUSC
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批准号:9898339
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项目类别:
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资助金额:$53.15万
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财政年份:2013
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负责人:Kevin M Gray
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依托单位:
Clinical Scientists Training in Addictions at MUSC
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批准号:10369717
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项目类别:
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资助金额:$53.15万
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财政年份:2013
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负责人:Kevin M Gray
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依托单位:
A Randomized Controlled Trial of Varenicline for Adolescent Smoking Cessation
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批准号:8466302
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项目类别:
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资助金额:$64.4万
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财政年份:2012
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负责人:Kevin M Gray
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依托单位:
A Randomized Controlled Trial of Varenicline for Adolescent Smoking Cessation
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批准号:8290925
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项目类别:
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资助金额:$62.42万
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财政年份:2012
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负责人:Kevin M Gray
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依托单位:
A Randomized Controlled Trial of Varenicline for Adolescent Smoking Cessation
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批准号:8660680
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项目类别:
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资助金额:$67.08万
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财政年份:2012
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负责人:Kevin M Gray
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依托单位:
A Controlled Trial of N-Acetylcysteine (NAC) in Cannabis Dependent Adolescents
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批准号:7894995
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项目类别:
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资助金额:$36.08万
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财政年份:2009
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负责人:Kevin M Gray
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依托单位:
A Controlled Trial of N-Acetylcysteine (NAC) in Cannabis Dependent Adolescents
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批准号:7687252
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项目类别:
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资助金额:$36.08万
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财政年份:2009
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负责人:Kevin M Gray
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依托单位:
Combined Pharmaco/Behavior Therapy in Adolescent Smokers
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批准号:7242507
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项目类别:
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资助金额:$31.15万
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财政年份:2003
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负责人:Kevin M Gray
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依托单位:
MUSC Specialized Center of Research Excellence on Sex Differences Renewal 2022
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批准号:10713308
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资助金额:$149.17万
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财政年份:2002
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负责人:Kevin M Gray
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依托单位:
海外基金