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临床试验/NCT02063984
NCT02063984已完成不适用

Behavioral Treatment of Adolescent Marijuana Use

Dartmouth-Hitchcock Medical Center2 个研究点 分布在 1 个国家目标入组 59 人开始时间: 2013年11月1日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
59
试验地点
2
主要终点
Any Cannabis Abstinence

研究概览

简要总结

This study will continue research designed to improve treatment outcomes for adolescent substance use disorders by integrating neuroscience- and behaviorally-based treatments. In particular, this project will be the first to evaluate whether Working Memory Training can enhance cognitive function and reduce impulsive decision making to improve abstinence outcomes. In addition, an adaptive abstinence-based incentive program will be evaluated as a new method for intervening with those who do not respond to their first-line treatment.

详细描述

The study will test two novel strategies to enhance outcomes. Working Memory Training (WMT), an efficacious method for strengthening specific cognitive processes, aims to improve factors (e.g., delay discounting / impulsive decision-making) that have shown a strong relation to substance use and treatment response. Second, more intensive and higher magnitude CM (ICM) will be used to motivate abstinence among teens who are not abstinent by Week 4. The investigators hypothesize that these strategies will improve outcomes by modifying a fundamental cognitive system involved in making choices to engage in risky behavior and by increasing motivation to abstain in early nonresponders. Aim 1 will pilot and refine the new procedures in a community clinic in preparation for the randomized trial. A sequential, multiple assignment randomized trial (SMART) will allow the study to determine the most effective first-line treatment and the most effective adaptive strategy (Aim 2). All teens will begin treatment with CM or CM/WMT. After 4 weeks, responders will continue in their first-line treatments, while nonresponders will be randomized to ICM or to continue with first-line treatment. Aim 3 will conduct mechanistic analyses to assess whether cognitive changes related to WMT engender increased abstinence, and whether specific tailoring variables moderate treatment effects. Aim 4 will gather formative data on implementation factors to inform future large-scale studies and dissemination efforts. Primary hypotheses are: (1) first-line treatment with WMT will improve abstinence outcomes and reduce relapse; (2) strategies with ICM for nonresponders will result in better outcomes than those without; (3) WMT will reduce delay discounting, which will predict outcome. The unique approach holds promise for reducing multiple types of risky behaviors by affecting basic mechanisms that determine impulsive decision-making.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Treatment
盲法
None

入排标准

年龄范围
12 Years 至 26 Years(Child, Adult)
性别
All
接受健康志愿者

入选标准

  • Participants must be 12 to 26 years of age, must live at home with the parent who will participate, report using marijuana during the previous 30 days or provide a marijuana-positive urine test, meet criteria for cannabis abuse or dependence, and have a parent who can participate.

排除标准

  • DSM criteria for dependence (likely to be adjusted for DSM-5 Use Disorder) on alcohol or other drugs other than marijuana (use of or meeting criteria for abuse of other substances will not be an exclusion criterion), active psychosis, severe medical or psychiatric illness limiting participation, or pregnant or breast-feeding.

结局指标

主要结局

Any Cannabis Abstinence

时间窗: Intervention weeks 1 to 14

Number of participants with any cannabis abstinence during treatment

Weeks of Continuous Cannabis Abstinence

时间窗: 14 week treatment period

Weeks of continuous abstinence during treatment

次要结局

  • Days of Cannabis Use(The intervention period between Week 1 and Week 14)
  • Weeks of Cannabis Abstinence Across Four Treatment Strategies(Treatment period between week 1 and week 14)
  • Any Cannabis Abstinence Across Four Treatment Strategies(Treatment period between week 1 and week 14)
  • Any Days of Cannabis Use(Intervention weeks 1 to 14)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Alan J. Budney

Professor

Dartmouth-Hitchcock Medical Center

研究点 (2)

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