A Teleheath tDCS Approach to Decrease Cannabis Use: Towards Reducing Multiple Sclerosis Disability
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 52
- 试验地点
- 1
- 主要终点
- Change in Kessler Psychological Distress Scale (K10) Score
研究概览
简要总结
The study aims to evaluate the effect of Dorsolateral Prefrontal Cortex (DLPFC) Transcranial Direct Current Stimulation (tDCS) in decreasing distress and cannabis use. 46 participants with Relapse Remitting Multiple Sclerosis (RRMS), Cannabis Use Disorder (CUD) and elevated distress (K10 score of 10-35) will be recruited.
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 (Participant, Investigator)
入排标准
- 年龄范围
- 21 Years 至 65 Years（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Ages 21-65 (inclusive)
- •Seeking treatment to reduce or discontinue current cannabis use (smoke/vape/ingest)
- •Current Cannabis Use Disorder per DSM-V (MINI for DSM-V)
- •K10 score 10-35, inclusive (mild to high moderate distress)
- •Definite MS diagnosis, relapsing remitting (RRMS) subtype
- •PDDS score 0-7 (mild to moderate neurological disability, established to be able to complete procedures)
- •All medications stable for ≥ 1 month prior to enrollment and throughout the trial
- •Ability to understand the informed consent process and provide consent to participate in the study
- •Stable and continuous access to internet service, email (WiFi "hotspot" to be provided if needed)
- •Ability to use mobile devices
- •Fluent in English language (due to outcomes validated in English versions only)
- •WRAT-4 score ≥ 85
排除标准
- •MS clinical relapse or use of high dose of steroids in the past month
- •Patients under medical marijuana use prescribed by a clinician
- •Alcohol, tobacco, or substance use disorder other than cannabis
- •Primary neurologic, psychiatric or other medical disorder other than MS (entry MD screening)
- •Currently meets DSM-V criteria for moderate or severe substance use disorder in the past 6 months for any psychoactive substance.
- •Meets DSM-V criteria for current panic disorder, obsessive-compulsive disorder, post-traumatic stress syndrome, bipolar affective disorder, schizophrenia, dissociate disorders, and any other psychotic disorder or organic mental disorder
- •Current suicidal ideation or deemed to be of potential risk of self-injury
- •History of traumatic brain injury
- •Seizure disorder or recent (<5 years) seizure history
- •Metal implants in the head or neck
- •Enrolled in group or individual therapy for substance use disorder concurrent to intervention
- •Any skin disorder or skin sensitive area near stimulation locations
- •Pregnant or breastfeeding
结局指标
主要结局
Change in Kessler Psychological Distress Scale (K10) Score
时间窗: Baseline, End of Intervention (Week 4)
K10 is a 10-item questionnaire intended to yield a global measure of distress based on questions about anxiety and depressive symptoms that a person has experienced in the most recent 4 week period. Each question is given a score between 1 (none of the time) to 5 (all of the time). The total score ranges from 10 to 50. People with scores \< 20 are likely to be well, 20-24 are likely to have a mild mental disorder, 25-29 are likely to have moderate mental disorder, and \> 30 are likely to have a severe mental disorder.
Change in Positive and Negative Affect Schedule Score - Positive Affect (PANAS-PA)
时间窗: Baseline, End of Intervention (Week 4)
The PA subscale includes 10 items describing positive mood states (e.g., "enthusiastic," "interested," "proud"), each rated on a Likert scale from 1 ("very slightly or not at all") to 5 ("extremely"). The total score ranges from 5-50; higher scores indicate greater levels of positive affect, reflecting an individual's engagement, energy, and pleasurable involvement with the environment.
Change in Positive and Negative Affect Schedule Score - Negative Affect (PANAS-NA)
时间窗: Baseline, End of Intervention (Week 4)
The NA subscale consists of 10 items representing negative mood states (e.g., "upset," "nervous," "hostile"), each rated on a 5-point Likert scale from 1 ("very slightly or not at all") to 5 ("extremely"). The total score ranges from 5-50; higher scores reflect greater levels of negative affect, capturing distress and unpleasurable engagement with the environment.
Change in Marijuana Craving Questionnaire (MCQ-17) Score
时间窗: Baseline, End of Intervention (Week 4)
MCQ is a standardized measure assessing marijuana craving. Each statement is scored on a 7 point likert scale of 1 (strongly disagree) and 7 (strongly agree). Questions 1-7 measure compulsivity. Questions 8-11 measure emotionality. Questions 12-15 measure expectations. Questions 16-17 measure purposefulness. The total score is the average response score and ranges from 1-7; higher scored indicate greater levels of marijuana craving.
Change in Cannabis Withdrawal Scale (CWS) Score
时间窗: Baseline, End of Intervention (Week 4)
The version of CWS used in the study asks about symptoms experienced over the last 24 hours and consists of 19 statements. For each statement, its negative impact on normal daily activities is rated on a likert scale from 0 (not at all) to 10 (extremely). The total score ranges from 0 to 190; higher scores indicate that symptoms are having a larger negative impact on normal daily activities.
Change in Number of Weekly Sessions of Cannabis Use
时间窗: Baseline, End of Intervention (Week 4)
Self-reported measure.
Change in Number of Monthly Sessions of Cannabis Use
时间窗: Baseline, End of Intervention (Week 4)
Self-reported measure.
次要结局
- Change in Kessler Psychological Distress Scale (K10) Score(End of Intervention (Week 4), Month 3)
- Change in Positive and Negative Affect Schedule Score - Positive Affect (PANAS-PA)(End of Intervention (Week 4), Month 3)
- Change in Positive and Negative Affect Schedule Score - Negative Affect (PANAS-NA)(End of Intervention (Week 4), Month 3)
- Change in Marijuana Craving Questionnaire (MCQ-17) Score(End of Intervention (Week 4), Month 3)
- Change in Cannabis Withdrawal Scale (CWS) Score(End of Intervention (Week 4), Month 3)
- Change in Number of Weekly Sessions of Cannabis Use(End of Intervention (Week 4), Month 3)
- Change in Number of Monthly Sessions of Cannabis Use(End of Intervention (Week 4), Month 3)