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临床试验/NCT02723149
NCT02723149已完成不适用

Marijuana Approach Bias Retraining and Neural Response in Youth

Medical University of South Carolina2 个研究点 分布在 1 个国家目标入组 41 人开始时间: 2015年11月最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
入组人数
41
试验地点
2
主要终点
Change in marijuana approach tendencies (via Approach Avoidance Assessment Task) as measured by reaction times.

研究概览

简要总结

This study aims to determine if a marijuana (MJ) Approach Avoidance Task (AAT) intervention reduces cannabis use compared to a control condition containing no active components of AAT. Adolescent heavy MJ users (N=40, ages 16-21) will be randomly assigned to MJ-AAT (n=20) or control condition (MJ-Sham, n=20) for three weeks. The MJ-AAT includes six sessions designed to reduce action tendencies to approach marijuana. The MJ-Sham includes six MJ-AAT-sham conditions. Substance use and cognitive assessment will identify changes in MJ use patterns and mechanisms of treatment outcomes. Additionally, using an functional magnetic resonance imaging marijuana cue reactivity task, we will determine differences in neural response in reward regions before and after 3 weeks of either AAT or sham treatment.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Health Services Research
盲法
Double (Participant, Investigator)

入排标准

年龄范围
16 Years 至 21 Years(Child, Adult)
性别
All
接受健康志愿者

入选标准

  • between age 16 and 21
  • having >50 lifetime marijuana use episodes and a pattern of at least weekly marijuana use for the past year (>1+/week for 52 weeks) at study entry.

排除标准

  • not having a parent to consent (for those under age 18)
  • prenatal alcohol (>2 drinks on an occasion or >4 drinks in a week) or any tobacco or illicit drug exposure
  • premature birth (<34 weeks gestation), birth weight <5 lbs, or other gestational or perinatal complications
  • history of a serious medical or neurological problems that could affect blood oxygen level dependent (BOLD) response, brain development, or study participation, including diabetes and recurrent migraine
  • current severe Diagnostic and Statistical Manual of Mental Disorders (DSM-5) major Axis I psychiatric disorder (i.e., exclude participants with bipolar disorder, psychotic disorder)
  • use of any illicit substance (e.g., cocaine, methamphetamines) other than alcohol or marijuana > 100 times
  • history of major neurological disorder or head trauma (with loss of consciousness >10 minutes)
  • history of learning disability, pervasive developmental disorder, or other condition requiring special education
  • current use of medications that affect cerebral blood flow
  • non-correctable visual or hearing problems
  • non-fluent in English
  • MRI contraindications (e.g., braces, claustrophobia, irremovable metal implants or piercings)
  • pregnant on day of scan
  • intake of psychoactive medication as tested by urine drug screen.

研究组 & 干预措施

Approach Avoidance Training Condition

Experimental

The AAT group will push away the joystick from marijuana pictures 90% of the trials and pull towards the marijuana pictures 10% of the trials.

干预措施: Marijuana Approach Avoidance Training (Behavioral)

Sham Condition

Sham Comparator

The sham group will undergo the same procedures, except the ratio for marijuana pictures will be 50% push and 50% pull.

干预措施: Marijuana Approach Avoidance Training (Behavioral)

结局指标

主要结局

Change in marijuana approach tendencies (via Approach Avoidance Assessment Task) as measured by reaction times.

时间窗: 3 weeks

Change in short-term marijuana use from baseline to 1 month post-intervention

时间窗: From 60 days before intervention to 1 month post-intervention

Assessing the short-term effects of intervention on marijuana use (as measured by number of days used marijuana X hits per day) from baseline to 1 month post-intervention.

Change in marijuana use from baseline through end of intervention

时间窗: From 60 days before intervention to end of 3 week intervention

Assessing the change in marijuana use (as measured by number of days used marijuana X hits per day) from baseline to end of intervention.

Change in neural reactivity (as measured by BOLD: Blood Oxygen Level-Dependent response) in reward regions during marijuana-cue reactivity task

时间窗: 3 weeks

Assessing the change in neural reactivity to marijuana cues before and after the intervention

次要结局

  • Change in long-term marijuana use from baseline to 1 year post-treatment(From 60 days before intervention to 1 year post-intervention)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (2)

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