Effect of Medical Marijuana on Neurocognition and Escalation of Use
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 269
- 试验地点
- 1
- 主要终点
- Mean Difference in Number of Cannabis Use Disorder Symptoms Averaged Over 2, 4, and 12 Weeks
研究概览
简要总结
This study will use a randomized controlled design to test whether patients who use medical marijuana, compared to a waitlist control group, experience a change in health outcomes (relief of symptoms, or adverse health outcomes such as new-onset symptoms of cannabis use disorders, neurocognitive impairments) or brain-based changes.
详细描述
This trial is a randomized, longitudinal study of medical marijuana (MM) that will: (1) characterize the impact of MM on indices of addiction, such as CUD, escalation of use, tolerance, and withdrawal among those who stop using, (2) assess, via dosing diaries, the effect of MM use patterns on use of other medications, and perception of underlying disease symptomatology, (3) characterize the impact of MM on neurocognitive performance, including executive function, memory, attention, and decision-making and (4) examine evidence for impact of MM on brain structure and function. This study will enroll 200 adults with no prior history of CUD or heavy marijuana use, who express interest in using MM to treat pain, insomnia, anxiety, and/or depression. Participants will be randomly assigned to either an active MM arm (n = 100), or to a waitlist control arm (WLC) (n = 100). Participants will be assessed at baseline, regularly for 3 months, and at a 6-month and 12-month follow-up for MM use behaviors, development of CUD, perception of disease symptomatology, and neurocognitive performance. Urine collected at each visit will be assessed with quantitative assays. MRI scans will be collected to longitudinally investigate possible brain changes associated with MM 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
- Double (Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Men and women aged 18-65 years, inclusive;
- •Competent and willing to provide written informed consent;
- •Desire to use medical marijuana for self-reported pain, sleep, or affective (mood and/or anxiety including PTSD) symptoms.
- •Not in possession of a medical marijuana card, but expressing intent to get one.
- •Able to communicate in English language.
排除标准
- •Current daily marijuana use (prior to enrollment)
- •Current substance use disorders (e.g. cocaine, opiate, stimulant). Light to moderate alcohol use is permitted (defined as 16 or less on the AUDIT), and nicotine dependence is permitted because of the high co-use of nicotine and marijuana. Participants cannot meet current SCID criteria for a use disorder on any illicit substance other than nicotine.
- •Pregnant (verified by a urine test).
- •In the opinion of the investigator, not able to safely participate in this study because of any medical or psychological issues (e.g. psychosis) that might compromise their safety.
研究组 & 干预措施
Medical Marijuana Arm
This group can begin using medical marijuana immediately.
干预措施: Medical Marijuana (Drug)
结局指标
主要结局
Mean Difference in Number of Cannabis Use Disorder Symptoms Averaged Over 2, 4, and 12 Weeks
时间窗: 2 weeks, 4 weeks, and 12 weeks
The DSM-5 Cannabis Use Disorder (CUD) Checklist will evaluate symptoms of CUD (number of symptoms). The scale ranges from 0-11, with a higher score indicating a greater number of cannabis use disorder symptoms. A trained member of study staff assessed number of CUD symptoms through a structured interview. Each item was scored as "1" if the participant endorsed the symptom, and scored as "0" if they did not endorse the symptom. Reported results are an average taken over weeks 2, 4, and 12 to be consistent with the regression model estimates.
Mean Difference in Anxiety Subscale Scores From the HADS Averaged Over 2, 4, and 12 Weeks
时间窗: 2 Weeks, 4 Weeks, and 12 Weeks
For those with anxiety symptoms, the anxiety subscale from the Hospital Anxiety and Depression Scale (HADS) will be used to assess symptoms. This subscale ranges from 0-21, with higher scores indicating worse anxiety outcomes. Reported results are an average taken over weeks 2, 4, and 12 to be consistent with the regression model estimates.
Mean Difference in Pain Severity Scores on the BPI Average Over 2, 4, and 12 Weeks
时间窗: 2 weeks, 4 weeks, and 12 weeks
For those with pain, the Brief Pain Inventory (BPI) severity subscale was used to assess pain symptoms. This scale ranges from 0-10, with a higher score indicating greater pain severity. Reported results are an average taken over weeks 2, 4, and 12 to be consistent with the regression model estimates.
Mean Difference in Sleep Scores on the AIS Averaged Over 2, 4, and 12 Weeks
时间窗: 2 weeks, 4 weeks, and 12 weeks
For those with insomnia, the Athens Insomnia Scale (AIS) will be used to assess insomnia symptoms. This scale ranges from 0-24, with higher scores indicating worse sleep outcomes. Reported results are an average taken over weeks 2, 4, and 12 to be consistent with the regression model estimates.
Mean Difference in Depression Subscale Scores From the HADS Averaged Over 2, 4, and 12 Weeks
时间窗: 2 weeks, 4 weeks, and 12 weeks
For those with depression symptoms, the depression subscale of the Hospital Anxiety and Depression Scale (HADS) will be used to assess symptoms. The subscale ranges from 0-21, with a higher score indicating worse depression outcomes. Reported results are an average taken over weeks 2, 4, and 12 to be consistent with the regression model estimates.
次要结局
- Mean Difference in Mental Health Scores on the SF-12 Averaged Over 2, 4, and 12 Weeks(2 weeks, 4 weeks, and 12 weeks)
- Mean Difference in Physical Health Scores on the SF-12 Averaged Over 2, 4, and 12 Weeks(2 weeks, 4 weeks, and 12 weeks)
- Mean Difference in Verbal Recognition Memory (VRM) Task: d' Scores on the CANTAB Averaged Over 4 and 12 Weeks(4 weeks and 12 weeks)
- Mean Difference in Attention Switching Task: Congruency Cost Scores on the CANTAB Averaged Over 4 and 12 Weeks(4 weeks and 12 weeks)
- Mean Difference in Attention Switching Task: Switching Cost Scores on the CANTAB Averaged Over 4 and 12 Weeks(4 weeks and 12 weeks)
- Mean Difference in Rapid Visual Information Processing (RVP) Task: Discriminability Scores on the CANTAB Averaged Over 4 and 12 Weeks(4 weeks and 12 weeks)
- Mean Difference in Paired Associates Learning (PAL) Task: Total Errors Scores on the CANTAB Averaged Over 4 and 12 Weeks(4 weeks and 12 weeks)
- Mean Difference in Spatial Working Memory (SWM) Task: Repetition Errors Scores on the CANTAB Averaged Over 4 and 12 Weeks(4 weeks and 12 weeks)
- Mean Difference in Verbal Recognition Memory (VRM) Task: Free Recall Memory Scores on the CANTAB Averaged Over 4 and 12 Weeks(4 weeks and 12 weeks)
研究者
Jodi Gilman
Assistant Professor
Massachusetts General Hospital