Evaluation of the Effect of tDCS on Cannabis Craving: Multicentre Randomized, Double-blind Study Versus Placebo
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 78
- 试验地点
- 2
- 主要终点
- Evaluating the change from craving to cannabis. by an analog visual scale .Scores (0 to 10)
研究概览
简要总结
Cannabis is the most frequently consumed drug in France and its use continues to increase. Over the 18-64 age group as a whole, experimentation with cannabis at least once in a lifetime increased from 33% in 2010 to 42% in 2014, confirming the upward trend observed since the 1990.
Cannabis, like all drugs, disrupts the reward circuit whose neurons originate in the ventral tegmental area and project into the mesolimbic and cortical structures.
Acute cannabis use is thought to increase mesolimbic dopamine by affecting the Gabaergic or Glutamatergic system.
Chronic cannabis use usurps the reward system and leads to changes in the mesolimbic circuit (nucleus accumbens, ventral tegmental area, amygdala, and prefrontal cortex), inducing increased craving, with persistent craving for the substance and vulnerability to relapse.
Cognitively, addiction is associated with increased impulsivity, with a propensity to take risks leading to impaired decision-making.
There is currently no validated drug treatment for cannabis addiction. Non-invasive brain stimulation could be an interesting therapeutic alternative.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Other
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 63 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Men or women between 18 and 65 years of age
- •Right-Handers
- •Diagnosis: Cannabis Use Disorder (according to DSM 5 criteria)
- •Patient with no other drug or psychotherapeutic treatment for cannabis addiction ("naive" patients)
- •Reported use of cannabis more than three times a week in the past three years
- •Signing consent to participate in research
排除标准
- •Pregnancy or lack of effective contraception
- •Patients with severe somatic disease
- •Other addictions of "moderate" to "severe" intensity according to DSM 5 criteria (excluding tobacco and coffee)
- •Patients undergoing antidepressant or neuroleptic or thyroid-regulating therapy.
- •Contraindications to tDCS (presence of an intracranial metal body, intracranial hypertension)
- •Topic that has already been stimulated by tDCS
- •Patients under reinforced guardianship or curatorship
结局指标
主要结局
Evaluating the change from craving to cannabis. by an analog visual scale .Scores (0 to 10)
时间窗: 3 months
次要结局
- The change to cannabis craving assessed by the Baseline Marijuana Craving Test at the end of treatment(3 month)
- The change in cannabis craving during an incentive to use task evaluated by analog visual scale scores (0 to 10)(3 months)
- evaluation of the change in the number of joints consumed per day(3 months)
- evaluation of the change in the number of cigarettes consumed per day(3 months)
- Montgomery-Åsberg depression rating scale) Scores (0 to 60)(3 months)
- the Gambling Task's assessment of decreased risk-taking(3 months)
- Young Mania Rating Scale Scores (0 to 60)(3 months)
- assessment of the change in attention and inhibition skills as assessed by the Stroop test before and after a neurofeedback test(3 months)
- Beck Depression Inventory Scores (0 to 39)(3 months)
- Clinical Global Impression Severity of disease (0 to 7)(3 months)
研究者
Januel
Head of the clinical research unit of ville evrard
Centre hospitalier de Ville-Evrard, France