Telehealth-Delivered tDCS for Cannabis Addiction Recovery: The C.A.R.E.S. (Cannabis Addiction Recovery Enhancement Stimulation) Initiative
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 46
- 试验地点
- 2
- 主要终点
- The proportion of participants with no serious adverse events
研究概览
简要总结
The purpose of this sham-controlled pilot randomized controlled trial (RCT) is to evaluate the feasibility, safety, and preliminary efficacy of a one-month intervention consisting of 20 home-based active or sham RS-tDCS sessions paired with audio track guided mindfulness meditation practice in otherwise healthy adults seeking to reduce cannabis use in the context of cannabis use disorder (CUD).
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
- Triple (Participant, Care Provider, Investigator)
入排标准
- 年龄范围
- 22 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Aged 22-65 years (inclusive)
- •Currently meets the Diagnostic and Statistical Manual of Mental Disorders (DSM-V) criteria for CUD, as determined by DSM-V criteria (M.I.N.I)
- •Positive for cannabis on the 11-COOH-THC single panel urine test
- •Seeking treatment to reduce or discontinue cannabis use (Marijuana Ladder ranged between 5-8 [inclusive])
- •Kessler Psychological Distress Scale (K10) score < 35 (minimal to moderate distress)
- •Wide Range Achievement Test-5(WRAT-5) score ≥ 85
- •Ability to use mobile devices
- •Fluent in English or Spanish
排除标准
- •Cannabis is used exclusively as prescribed or directed by their provider
- •Meets DSM-V criteria for substance use disorder within the past six months for any psychoactive substance other than cannabis
- •Meets DSM-V criteria for alcohol use disorder within the past six months
- •Primary psychiatric disorder (major depressive disorder, bipolar disorder, or psychotic disorder) as the principal diagnosis, independent of cannabis use disorder; or current diagnosis of bipolar disorder, psychotic disorder, or any other alcohol/substance use disorder as defined by DSM-5-TR and confirmed via the Mini-International Neuropsychiatric Interview (MINI).
- •Primary neurologic or major medical disorder that would interfere with study participation.
- •Enrolled in group or individual therapy for substance use disorder that would be concurrent with the study intervention
- •History of moderate or severe traumatic brain injury
- •Seizure disorder or recent (<5 years) seizure history
- •Presence of metal or active implants in the head/neck
- •Any skin disorder or skin sensitive area near stimulation locations
- •Pregnant or planning pregnancy during the study period or breastfeeding
研究组 & 干预措施
Sham tDCS
Participants will complete 20 RS sham sessions, each 20 minutes, of active DLPFC tDCS combined with mindfulness meditation.
干预措施: Mindfulness meditation (Behavioral)
Active tDCS
Participants will complete 20 remotely supervised (RS) daily sessions, each 20 minutes, of active dorsolateral prefrontal cortex (DLPFC) tDCS combined with mindfulness meditation.
干预措施: Active Transcranial Direct Current Stimulation (tDCS) (Device)
Active tDCS
Participants will complete 20 remotely supervised (RS) daily sessions, each 20 minutes, of active dorsolateral prefrontal cortex (DLPFC) tDCS combined with mindfulness meditation.
干预措施: Mindfulness meditation (Behavioral)
Sham tDCS
Participants will complete 20 RS sham sessions, each 20 minutes, of active DLPFC tDCS combined with mindfulness meditation.
干预措施: Sham Transcranial Direct Current Stimulation (tDCS) (Device)
结局指标
主要结局
The proportion of participants with no serious adverse events
时间窗: End of treatment (up to 6 weeks)
The proportion of participants who complete at least 70% (14 out of 20) of intervention sessions
时间窗: End of treatment (up to 6 weeks)
The proportion of participants who discontinue due to adverse effects
时间窗: End of treatment (up to 6 weeks)
Change in cannabis use frequency, measured by the Daily Sessions, Frequency, Age of Onset, and Quantity of Cannabis-Use Inventory (DFAQ-CU)
时间窗: Baseline, End of treatment (up to 6 weeks)
The DFAQ-CU is a self-report scale used to assess cannabis use behaviors. It measures frequency, quantity, age of onset, and daily sessions of cannabis use, including different forms like dry product, concentrates, and edibles. The DFAQ-CU also includes visual aids and questions about methods of cannabis administration and tetrahydrocannabinol (THC) levels. Questions 2-3, 6-12 assess frequency.
Change in daily cannabis use, measured by the Timeline Followback (TLFB) method assessment
时间窗: Baseline, End of treatment (up to 6 weeks)
Daily cannabis use is assessed using the TLFB method, a validated self-report instrument used to collect retrospective estimates of daily cannabis use.
Change in cannabis withdrawal symptoms, measured by the Cannabis Withdrawal Scale (CWS)
时间窗: Baseline, End of treatment (up to 6 weeks)
The CWS assesses withdrawal 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 withdrawal symptoms have a larger negative impact on normal daily activities.
次要结局
- Change in cannabis craving, measured by the Marijuana Craving Questionnaire (MCQ-17)(Baseline, 1-month follow-up)
- Change in psychological distress as measured by the Kessler Psychological Distress Scale (K10)(Baseline, 1-month follow-up)
- Change in anxiety as measured by State-Trait Anxiety Inventory (STAI)(Baseline, 1-month follow-up)
- Change in function as measured by the Marijuana Problem Scale (MPS)(Baseline, 1-month follow-up)
- Change in depression as measured by the Beck Depression Inventory (BDI)(Baseline, 1-month follow-up)
- Change in cannabis use frequency, measured by the Daily Sessions, Frequency, Age of Onset, and Quantity of Cannabis-Use Inventory (DFAQ-CU)(Baseline, 1-month follow-up)
- Change in daily cannabis use, measured by the Timeline Followback Method Assessment (TLFB)(Baseline, 1-month follow-up)
- Change in cannabis withdrawal symptoms, measured by the Cannabis Withdrawal Scale (CWS)(Baseline, 1-month follow-up)