N-Acetylcysteine and Contingency Management for Youth Cannabis Use Disorder
N-Acetylcysteine and Contingency Management for Youth Cannabis Use Disorder
批准号:
9156301
负责人:
Kevin M Gray
金额:
$60.96万
依托单位国家:
美国
项目类别:
财政年份:
2017
资助国家:
美国
项目状态:
已结题
起止时间:
2017-03-15 至 2022-01-31
关键词:
AbstinenceAcademic achievementAcetylcysteineAchievementAcuteAddressAdultAdverse effectsAftercareAntioxidantsAttentionBehavior TherapyBehavioralBrainCannabinoidsCannabisCognitionCognitiveCounselingDevelopmentDouble-Blind MethodEvidence based treatmentGeneral PopulationImpaired cognitionLifeMedication ManagementMemoryModalityOutcomeParticipantPerformancePharmaceutical PreparationsPhasePlacebosPositioning AttributeProgram DevelopmentRandomizedResearch PersonnelRoleTask PerformancesTestingTranslatingTranslationsUrineWithholding TreatmentWorkYouthactive methodcannabis cessationclinical practicecognitive controlcognitive taskcomparative efficacycontingency managementdesignexperienceimprovedlearning abilitymarijuana usemarijuana use disordernovel strategiesprocessing speedresponsetherapy developmenttreatment grouptrial design
中文摘要
摘要
大麻的使用在青年中特别普遍和成问题。相比之下,
在接触大麻的成年人中,每六个接触大麻的青年中就有一个患上大麻使用障碍。此外,委员会认为,
青少年比成年人更容易受到使用大麻的潜在持久不良影响,包括认知能力
损害,改变大脑发育,教育成果差,生活成就减少。尽管
相对较少的工作集中在开发最佳有效的大麻使用障碍治疗,
特别是在年轻人中。目前的循证治疗通常传达小到中等的效果大小,
and novel新approaches方法are critical迫切needed需求.最有希望的方法之一是非处方药
抗氧化药物N-乙酰半胱氨酸(NAC)和行为治疗应急管理(CM)。
我们的研究小组先前证明,与安慰剂(PBO)相比,NAC在青少年中具有上级戒断结局,
CUD同时接受CM。现在需要进一步的工作来解开NAC和CM的影响。
它们可能是协同作用的,它们的结合对于最大限度地提高禁欲效果至关重要。
或者,NAC可能独立于CM有效,但尚未正式评估。为了
最佳地将NAC和CM的发现转化为现实世界的临床实践,它们对戒烟的相对贡献
必须对成果进行正式评估。我们提出了一个为期12周的2 × 2析因设计的NAC和CM试验,
青年人CUD(N=336)。受试者将被随机分配至双盲NAC或PBO组和CM组或无CM组,
产生四个均等分配的治疗组:NAC + CM、NAC +无CM、PBO + CM和PBO +无CM。
所有参与者将接受每周简短的大麻戒烟咨询和药物管理。的
主要疗效结果将是12周活性治疗期间尿大麻素试验阴性的比例
治疗,组间比较。我们还将连续评估认知任务的表现,检查
实现禁欲的参与者与未实现禁欲的参与者之间的表现变化。这一拟议
在评估NAC和CM作为非常有前途的青年CUD治疗方面,试验是明确的“下一步”
模式,并定位为告知研究人员,临床医生和公众,解决一个关键的
需要优化青年CUD治疗。
英文摘要
Abstract
Cannabis use is particularly prevalent and problematic amount youth. Compared with only one in eleven
cannabis-exposed adults, one in six cannabis-exposed youth develops cannabis use disorder. Moreover,
youth are more prone than adults to potentially lasting adverse effects of cannabis use, including cognitive
impairment, altered brain development, poor educational outcome, and diminished life achievement. Despite
this, relatively little work has focused on developing optimally efficacious cannabis use disorder treatments,
particularly among youth. Current evidence-based treatments convey generally small to modest effect sizes,
and novel approaches are critically needed. Among the most promising approaches are the over-the-counter
antioxidant medication N-acetylcysteine (NAC) and the behavioral treatment contingency management (CM).
Our team previously demonstrated superior NAC versus placebo (PBO) abstinence outcomes in youth with
CUD who concurrently received CM. Further work is now needed to disentangle the effects of NAC and CM.
It is possible that they are synergistic, with their combination being critical to maximizing abstinence outcomes.
Alternatively, NAC may be efficacious independent of CM, but this has not been formally evaluated. In order to
optimally translate NAC and CM findings to real-world clinical practice, their relative contributions to cessation
outcomes must be formally evaluated. We propose a 12-week 2 x 2 factorial design trial of NAC and CM for
CUD in youth (N=336). Participants will be randomized to double-blind NAC or PBO and to CM or no CM,
yielding four equally-allocated treatment groups: NAC + CM, NAC + No CM, PBO + CM, and PBO + No CM.
All participants will receive brief weekly cannabis cessation counseling and medication management. The
primary efficacy outcome will be the proportion of negative urine cannabinoid tests during the 12-week active
treatment, compared between groups. We will also serially assess cognitive task performance, examining
changes in performance among participants who achieve abstinence versus those that do not. This proposed
trial is the clear “next step” in the assessment of NAC and CM as extremely promising youth CUD treatment
modalities, and is positioned to inform researchers, clinicians, and the general public, addressing a critical
need for optimization of youth CUD treatments.
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会议论文
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