NCT06941298招募中不适用
Neural and Psychiatric Consequences of Cannabis Use in Adolescents
适应症
干预措施
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 280
- 试验地点
- 2
- 主要终点
- Depression Severity measured by the Beck Depression Inventory (BDI)
研究概览
简要总结
The goal of this study is to investigate the effects of cannabis on brain function among adolescents with depression.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Basic Science
- 盲法
- None
入排标准
- 年龄范围
- 14 Years 至 20 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •at baseline.
- •Cannabis users: To capture a wide range of cannabis use frequency, meeting DSM-5 criteria for cannabis use disorder will not be required. However, in order to ensure sufficient exposure, we will require majority of adolescents with cannabis use to have a significant cannabis use (self-reported use on more or equal to 10 of the prior 30 days and positive THC urine toxicology).
- •Depression: Similarly, to capture a wide range of depression illness severity, we will allow participants with subthreshold depression, defined as a raw severity score of >=30 on the Children's Depression Rating Scale-Revised (CDRS-R, for ages 14-17) and as a raw severity score of >=12 on the Montgomery Asberg Depression Rating Scale (MADRS, for ages 18-20). However, we plan for at least 50% of participants with depressive symptoms to have a raw severity score of >=40 on the CDRS-R and of >=20 MADRS, which are considered reliable for depression. Additionally, we will allow participants with a research diagnosis of Major Depressive Disorder as defined by the MINI, even with a CDRS-R score below 30 or a MADRS score below
- •Moreover, because there could be individuals without MDD who have current depressive symptoms, individuals who lack a diagnosis of a depressive disorder but have a CDRS-R score of 30 (or higher) or a MADRS score of 12 (or higher) will be allowed. Through careful recruitment, we will ensure distributions of depression severity. Based on our prior studies employing similar criteria, we anticipate that anhedonia, anxiety and depression severity scores will be normally distributed in our samples.
排除标准
- •All participants:
- •Psychotropic medication free for more than 1 month (or more than three months for medications with a long half-life such as fluoxetine) prior to study enrollment. We have successfully enrolled hundreds of psychotropic medication-free depressed adolescents and young adults to date. Psychotherapy will be allowed.
- •MRI contraindications such as claustrophobia, metallic ink tattoos, orthodontic braces, or pacemakers
- •Positive pregnancy tests
- •Neurological illnesses and medical conditions such as unique pain syndromes (e.g. multiple sclerosis, rheumatoid arthritis)
- •Estimated full-scale IQ <=80 to ensure that participants have the ability to understand the study
- •Current SUD other than cannabis or nicotine. Excluding nicotine use will limit generalization of our findings and impact feasibility. Similarly, alcohol use will be allowed as long as it is not hazardous and does not meet criteria of a DSM-5 disorder (AUDIT-C >5). Therefore, nicotine and alcohol use will be allowed and controlled for. Alcohol and cannabis use (assessed based on breathalyzer from alcohol and self-report for cannabis/THC) on the day of the scan will result in rescheduling the scan as it can affect MRI data.
- •Certified for or self-reported medical cannabis use, or intent to become certified, current stimulant use (methamphetamine or cocaine) by self-report or urine toxicology. Adderall and Vyvanse for ADHD will be allowed as long as use is temporarily paused medication usage at least 3 days before neuroimaging visit. If medication is not discontinued on scan day, scanning at that time will be up to PI discretion.
- •Oral contraceptives will be allowed and controlled for in order to maximize recruitment of older adolescents.
- •Depressed THC non-users:
- •DSM-5 diagnoses of bipolar disorder, psychotic disorders, autism spectrum disorders, and all non-cannabis substance-related disorders will be exclusionary. However, anxiety disorders, obsessive-compulsive disorder (OCD), and post-traumatic stress disorder (PTSD) are not uncommon among depressed individuals and will be allowed as long as depressive symptoms are primary. Our focus on behavioral constructs aims to address comorbidity and mechanistic overlap among psychiatric disorders. Were these diagnoses exclusionary, the sample would be highly atypical of depression.
- •Self-injurious acts (e.g. cutting) and suicidal ideations (SI) without a specific plan (defined as passive SI) are common in adolescent depression and will be allowed. However, if SI constitutes an imminent risk to self or others (defined as active SI), the adolescent will be withdrawn from the study and emergency procedures will be initiated immediately, including ER admission (see Protection of Human Subjects).
- •Healthy controls will have no lifetime history of any major psychiatric diagnoses and no use of any THC.
研究组 & 干预措施
Neuroimaging Investigation Group
Experimental
Participants in this group will receive neuroimaging investigation for up to 2 years.
干预措施: Neuroimaging Investigation (Behavioral)
结局指标
主要结局
Depression Severity measured by the Beck Depression Inventory (BDI)
时间窗: Up to 3 years
Scores range from 0-63 with a higher score indicating higher depression severity
Anhedonia Severity measured by the Temporal Experience of Pleasure Scale (TEPS)
时间窗: Up to 3 years
Scores range from 18-108 with a higher score indicating higher Anhedonia severity
Cannabis Use measured by the Daily Frequency, Age of Onset, and Quantity of Cannabis Use (DFAQCU) Inventory
时间窗: Up to 3 years
Scores range from 1-15 with a higher score indicating more Cannabis Use
次要结局
- Cannabis Use measured by a quantitative cannabinoid metabolites urine analysis(Up to 3 years)
- Cannabis Use measured by the Cannabis Use Problems Identification Test (CUPIT)(Up to 3 years)
- Anhedonia Severity measured by the Snaith-Hamilton Pleasure Scale (SHAPS)(Up to 3 years)
- Depression Severity measured by the Convergence of Children's Depression Rating Scale-revised (CDRSR)(Up to 3 years)
- Depression Severity measured by the Montgomery-Åsberg Depression Rating Scale (MADRS)(Up to 3 years)
研究者
Vilma Gabbay
Professor
University of Miami
研究点 (2)
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