Medications Development for the Treatment of Cannabis Related Disorders
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 63
- 试验地点
- 2
- 主要终点
- withdrawal symptom severity, measured on a 0 (not at all) to 3 (severe) scale
研究概览
简要总结
The primary objective of this application is to test the neurobehavioral mechanisms and effects of aprepitant as a new cessation agent for cannabis, tobacco or both.
详细描述
Stress (emotional, physical, social) facilitates drug seeking behavior through the activation of the HPA axis, autonomic nervous system, and brain DA systems. Furthermore, alterations within several neuropeptide systems (CRF, Substance P, and others) also contribute to the role of stress in addiction. Central to this project is that anxiety and stress responses are modulated by substance P and its preferred target, the NK1 receptor. Therefore the aim of this pilot clinical trial is to determine the safety and efficacy of aprepitant (a neurokinin 1 (NK1) receptor antagonist). We hypothesize that the NK1 receptor antagonist, aprepitant, will be safe, tolerable and efficacious at reducing the withdrawal symptoms, cue craving, and reinforcement value for both cannabis and tobacco resulting from the cessation of either or both drugs. We will assess this hypothesis in the context of a carefully controlled human laboratory study in which subjects (N=72) will be randomized in a 3 x 2 factorial design to one of 3 behavioral conditions; a) withdrawn from both substances, b) withdrawn from tobacco only, or c) withdrawn from cannabis only, and to receive one of 2 medication dose conditions: placebo or aprepitant (160 mg/day). Medication will be administered for 5 days, followed by a cue challenge, choice procedure, and then a consequence (i.e., oral cannabis or a cigarette or money) also on day 5.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Single Group
- 主要目的
- Basic Science
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 45 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Must meet DSM-IV/ICD-10 criteria for cannabis abuse or dependence
- •Must be non-treatment seeking individuals
- •Participant does not meet DSM-IV criteria for any current (i.e., criteria met at any point in the past 30 days) dependence on a substance other than alcohol, nicotine, caffeine, or marijuana or physiological dependence on alcohol requiring medical detoxification.
- •No subjects who have trouble reading the English language or visual or hearing problems that may interfere with the collection of data
- •Not currently taking other medications (with the exception of oral contraceptives) that would preclude safe participation in this study
- •Must test negative for pregnancy prior to inclusion
- •females using birth control pills must agree to use a condom during intercourse for 1 month after participation in study because the study medication will decrease the effectiveness of the birth control pill rendering it ineffective
- •Should be in general good health
- •No evidence of recent use of other illicit drugs on a urine toxicity screen prior to admission
排除标准
- •Major current (within last 90 days) Axis I psychopathology (e.g., major depressive disorder, bipolar disorder, schizophrenia)
- •Presence of significant medical illness (e.g., diabetes, cardiovascular disease, hypertension, cancer, epilepsy, kidney disease)
- •Current, repeated illicit drug use (other than marijuana)
- •Subject is breastfeeding or pregnant
- •Concurrent therapy with drugs known to inhibit CYP3A4 activity
- •Request for drug treatment
- •Current parole or probation
- •Recent history of significant violent or suicide behavior
- •Allergic to sesame oil
研究组 & 干预措施
Behavioral Condition 1
Nicotine patch (21 mg) plus placebo oral cannabis (0 mg; 3 times a day on days 2-4, given once on day 5)
干预措施: Placebo Aprepitant (Drug)
Behavioral Condition 1
Nicotine patch (21 mg) plus placebo oral cannabis (0 mg; 3 times a day on days 2-4, given once on day 5)
干预措施: Active Aprepitant (Drug)
Behavioral Condition 2
Placebo nicotine patch (0 mg) plus oral cannabis (10 mg, 3 times each day, days 2-4, day 5 given once)
干预措施: Placebo Aprepitant (Drug)
Behavioral Condition 2
Placebo nicotine patch (0 mg) plus oral cannabis (10 mg, 3 times each day, days 2-4, day 5 given once)
干预措施: Active Aprepitant (Drug)
Behavioral Condition 3
Placebo nicotine patch (0 mg) plus placebo oral cannabis (0 mg, 3 times each day days 2-4, day 5 given once)
干预措施: Placebo Aprepitant (Drug)
Behavioral Condition 3
Placebo nicotine patch (0 mg) plus placebo oral cannabis (0 mg, 3 times each day days 2-4, day 5 given once)
干预措施: Active Aprepitant (Drug)
结局指标
主要结局
withdrawal symptom severity, measured on a 0 (not at all) to 3 (severe) scale
时间窗: collected on each study day
Subjective experience of withdrawal symptoms for cannabis, tobacco, and both (eg: Irritability, Sleep difficulty, Chills, Nervousness)
"craving" measured using the Marijuana craving questionaire and the tobacco craving questionaire
时间窗: collected on each study day
Subjective measures of craving for cannabis, tobacco, and both Questionaires are anchored with strongly disagree to strongly agree (1-7)
reinforcing effects, as measured using the Multiple Choice Questionaire
时间窗: collected each day of study
Reinforcement value of cannabis and tobacco as measured by preference for money over the administration of either drug; questionaire has 70 questions and money value vs. drug ranges from 25 cents to 25 dollars 1-70.
次要结局
- sleep quality(collected on each study day)
- Neurocognitive Function(collected on days 1-4 of the study)
- Number of Participants with Adverse Events as a Measure of Safety and Tolerability(each day of study)