Facilitating the Behavioral Treatment of Cannabis Use Disorder
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 8
- 试验地点
- 1
- 主要终点
- Percentage of Participants With Cannabis Abstinence or Significant Reduction in Cannabis Use
研究概览
简要总结
Cannabis use disorders remain a significant public health problem. The pharmacological facilitation of behavioral treatment represents a promising strategy for addressing disordered cannabis use. Cannabis use disorders are recognized to be associated with various vulnerabilities that complicate the course of treatment and that may be amenable to glutamate modulators. The purpose of this single blind open-label trial is to test the feasibility of administering glutamate modulators in conjunction with motivational enhancement therapy (MET) and mindfulness based relapse prevention (MBRP) for cannabis use disorders.
详细描述
Individuals diagnosed with cannabis dependence will receive one or two infusions of glutamate modulators during week 2 and week 3 or 4. The participants will also receive 2-week course of MET and 4-week course of MBRP. Participants will meet with staff twice weekly, except for week 2 and potentially week 3 or 4 during which participants will present to the clinic three times. Clinic visits include MET sessions, MBRP sessions, psychiatric monitoring, assessments, and study procedures (e.g., medication administration).
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- Single (Participant)
盲法说明
Open label single-blind trial, with participants given the impression they may get any of several medications.
入排标准
- 年龄范围
- 21 Years 至 60 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Meets DSM-IV criteria for cannabis dependence, with at least 5 days of use per week over the past 30 days and displaying at least one positive utox during screening
- •Physically healthy
- •No adverse reactions to study medications
- •21-60 years of age
- •Capacity to consent and comply with study procedures
- •Seeking treatment
排除标准
- •Meets DSM IV criteria for current major depression, bipolar disorder, schizophrenia, any psychotic illness, including substance-induced psychosis, and current substance-induced mood disorder.
- •Physiological dependence on another substance requiring medical management, such as alcohol, opioids, or benzodiazepines, excluding caffeine, and nicotine.
- •Pregnant, interested in becoming pregnant, or lactating
- •Delirium, Dementia, Amnesia, Cognitive Disorders, or dissociative disorders
- •Current suicide risk or a history of suicide attempt within the past 2 years
- •On psychotropic or other medication whose effect could be disrupted by participation in the study
- •Recent history of significant violence (past 2 years).
- •Heart disease as indicated by history, abnormal ECG, previous cardiac surgery.
- •Unstable physical disorders which might make participation hazardous such as end-stage AIDS, hypertension (>140/90), anemia, pulmonary disease, active hepatitis or other liver disease (transaminase levels < 2-3 X the upper limit of normal will be considered acceptable), or untreated diabetes
- •Previous history of misuse of study medications
- •BMI > 35, or a history of undocumented obstructive sleep apnea
- •First degree relative with a psychotic disorder (bipolar disorder with psychotic features, schizophrenia, schizoaffective disorder, or psychosis NOS)
研究组 & 干预措施
CI-581a+MET+MBRP
Administration of CI-581a during wk 2 and possibly at wk 3 or 4 at 0.71 mg/kg in the context of a 2 wk course of MET followed by a 4 wk course of MBRP
干预措施: CI-581a (Drug)
结局指标
主要结局
Percentage of Participants With Cannabis Abstinence or Significant Reduction in Cannabis Use
时间窗: At Week 6 (End of study)
Percentage of participants with cannabis abstinence or significant reduction in cannabis use by end of study. Significant reduction in cannabis use was defined as: At least 50% reduction in cannabis use between pre-infusion and end of 6 week study.
次要结局
- Confidence in Abstaining From Cannabis(Change between pre-infusion and end of 6 week study)
研究者
Elias Dakwar
research psychiatrist
New York State Psychiatric Institute