NCT07838311尚未招募4 期
Randomized Controlled Study of Delayed-Release, Extended-Release Methylphenidate (Jornay PM) in Adolescents and Young Adults With ADHD and Co-Occurring Cannabis Use Disorder
适应症
干预措施
相关药物
试验速览
- 阶段
- 4 期
- 状态
- 尚未招募
- 入组人数
- 66
- 试验地点
- 1
- 主要终点
- ADHD Symptom Reduction as Measured by Adult ADHD Investigator Symptom Rating Scale (AISRS)
研究概览
简要总结
The goal of this clinical trial is to look at how delayed-release, extended-release methylphenidate (Jornay PM), an FDA-approved medication for the treatment of Attention-Deficit Hyperactivity Disorder (ADHD), works to treat ADHD symptoms in adolescents and young adults (ages 16-26) with ADHD and Cannabis Use Disorder. Researchers will compare delayed-release, extended-release methylphenidate to a placebo (a look-alike substance that contains no drug).
Participants will be assigned to take either delayed-release, extended-release methylphenidate or a placebo every night over 12 weeks. Throughout the study, participants will provide urine samples and complete questionnaires about their ADHD symptoms, cannabis use, and other substance use.
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
盲法说明
All study staff will be blinded.
入排标准
- 年龄范围
- 16 Years 至 26 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Male or female subjects, 16-26 years of age at the time of consent
- •An established diagnosis of ADHD and CUD based on the DSM-5
- •ADHD severity of 4 or greater as determined by the Clinical Global Impression-Severity (CGI-S) scale
- •Subject must be interested in or currently participating in some type of treatment for their CUD, including, but not limited to, outpatient individual therapy, outpatient group therapy, CUD-directed pharmacotherapy, Marijuana Anonymous, Alcoholics Anonymous, or Narcotics Anonymous
- •Subject must report cannabis use on at least 3 of the 7 days prior to study enrollment
- •Subject must have a level of understanding sufficient to communicate intelligently with the investigator and study staff to complete study tasks in English
- •Subject must be willing to cooperate with all tests and examinations required by the protocol
- •Subject must be domiciled in the state of Massachusetts
排除标准
- •Subjects who are pregnant or nursing, or subjects unable or unwilling to use birth control. Birth control includes, but is not limited to:
- •i. hormonal methods, such as birth control pills, patches, injections, vaginal rings, or implants
- •ii. barrier methods (such as a condom or diaphragm) used with a spermicide (a foam, cream, or gel that kills sperm)
- •iii. intrauterine device (IUD)
- •iv. abstinence (no sex)
- •Subjects who present a negative urine dipstick result for cannabis use at baseline or report fewer than 3 use days of cannabis in week preceding study enrollment
- •Subjects with major untreated psychopathology, psychosis, suicidality, or concurrent active non-nicotine SUD other than CUD that, in the investigators' opinion, place them at risk for the adverse effects or need for additional care
- •Subjects who are unwilling or unable to comply with study procedures
- •Subjects who refuse additional substance-related interventions
- •Subjects with known medical risk factors (e.g., known untreated hypertension, arrhythmia, premature family history of sudden death) and active symptoms that, in the investigators' opinion, place them at risk for untoward adverse effects
- •Subjects with previous poor response or poor tolerability to methylphenidate
- •Investigator and his/her immediate family; defined as the investigator's spouse, parent, child, grandparent, or grandchild
- •Subjects who are unable to swallow large capsules
- •Subjects with a known allergy to study medication or known hypersensitivity to methylphenidate HCL or product components
- •Subjects with concurrent treatment with a monoamine oxidase inhibitor (MAOI) or use of an MAOI within the preceding 14 days
- •Subjects who have ever taken Jornay PM in the past
研究组 & 干预措施
Delayed-release, extended release methylphenidate
Active Comparator
干预措施: Delayed-release, extended-release methylphenidate (Drug)
Placebo
Placebo Comparator
干预措施: Placebo (Drug)
结局指标
主要结局
ADHD Symptom Reduction as Measured by Adult ADHD Investigator Symptom Rating Scale (AISRS)
时间窗: Baseline to week 12
ADHD symptom severity will be assessed using the AISRS, which consists of 18 items scored from 0 to 3, yielding a total score of 0-54; higher scores indicate greater symptom severity. The outcome is change in AISRS total score from baseline to week 12.
次要结局
- Change in Cannabis Use as Measured by Timeline Followback (TLFB)(The 28 days preceding treatment initiation and the final 28 days of treatment (weeks 9-12))
研究者
Aaron Quiggle
Medical Director, Addiction Recovery Management Services (ARMS)
Massachusetts General Hospital
研究点 (1)
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