EUCTR2017-000736-33-ES进行中（未招募）1 期
A randomized, subject and investigator blinded, placebo-controlled, parallel group study to investigate whether AFQ056 reduces cocaine use in patients diagnosed with Cocaine Use Disorder (CUD).
ovartis Farmacéutica S.A.0 个研究点目标入组 60 人开始时间: 2017年8月18日最近更新:
适应症
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 60
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
入选标准
- •1) Understand the study procedures and provide written informed consent before any assessment is performed.
- •2) Male and female subjects, 18 to 65 years of age (inclusive) and diagnosed with Cocaine Use Disorder according to DSM 5 (Diagnostic and Statistical Manual of Mental Disorders, 5th Ed.).
- •3) Must use cocaine through snorting (intranasally), as primary route of administration.
- •4) Recent cocaine use confirmed by positive urine screen for 1 or more benzoylecgonine (BE)
- •5) Must be seeking treatment for cocaine dependence and have a desire to reduce or cease cocaine use as per goals assessed at baseline.
- •6) Must be abstinent from cocaine use for at least 3 days preceding 1st dosing (Day 1) as assessed by self-report TLFB and two *urinalysis samples at baseline.
- •* difference in BE level between two baseline's samples must decrease
- •7) Must be in good health as determined by medical history, physical examination, at screening
- •8) At screening, and baseline, vital signs (systolic and diastolic blood pressure and pulse rate) must be within the acceptable ranges by the investigator considering the cocaine's increasing effect on pulse rate in order for the subject to qualify. Investigator may be guided to use the below ranges:
- •- systolic blood pressure, 90-150 mmHg
- •- diastolic blood pressure, 50-90 mmHg
- •Three readings are acceptable. At least the one of three reading must be within the acceptable ranges.
- •9) Patients must be able to:
- •- communicate well verbally with the Investigator and to understand written instructions
- •- verbalize a willingness to complete all study procedures
- •- verbally acknowledge that she/he will be able to attend each scheduled visit, and that she/he does not have any already scheduled events or activities that may substantially interfere with study participation
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range 60
- •F.1.3 Elderly (>=65 years) no
- •F.1.3.1 Number of subjects for this age range 0
排除标准
- •1) History of hypersensitivity to any of the study treatments or excipients or to drugs of similar chemical classes.
- •2) Has current diagnosis of Substance Use Disorder (according to the DSM 5) on alcohol, cannabis or other stimulants, except cocaine.
- •3) Meets current or lifetime DSM 5 criteria for schizophrenia or any psychotic disorder, or organic mental disorder.
- •4) Have current treatment for Substance Use Disorder (e.g.: disulfiram, acamprosate, methyl phenidate, modafinil, topiramate, immediate release dexamfetamine, or baclofen).
- •5) Requires treatment with any psychoactive medications, including any anti-seizure medications (with an exception of medications used for short-term treatment of insomnia)
- •6) Use of other investigational drugs at the time of screening, or within 5 half-lives of enrollment, or within 30 days, whichever is longer; or longer if required by local regulations.
- •7) Pregnant or nursing (lactating) women, where pregnancy is defined as the state of a female after conception and until the termination of gestation, confirmed by a positive hCG laboratory test
- •8) Women of child-bearing potential, defined as all women physiologically capable of becoming pregnant, unless they are using effective methods of contraception during dosing and for 30 days after last dosing of study medication.
- •9) History of Porphyria.
- •10) History or presence of malignancy of any organ system, (other than localized basal cell carcinoma of the skin or in-situ cervical cancer), treated or untreated, within the past 5 years, regardless of whether there is evidence of local recurrence or metastases
- •11) Have a history of any illness, condition, and use of medications that in the opinion of the investigator or designee might confound the results of the study or pose additional risk in administering the investigational agents to the subject or preclude successful completion of the study
- •12) Any surgical or medical condition which might significantly alter the absorption, distribution, metabolism, or excretion of drugs, or which may jeopardize the subject in case of participation in the study.
- •13) Current or/and previous treatment with concomitant medications that are strong or moderate inducers/inhibitors of CYP3A4 (e.g., Clarithromycin, ketoconazole, ritonavir, etc.)
- •14) Concomitant use of agents known to prolong the QT interval unless these can be permanently discontinued for the duration of study.
- •15) History or current diagnosis of ECG abnormalities, at screening or baseline, indicating significant risk of safety for subjects participating in the study
- •16) Known history or presence of cardiovascular or cerebrovascular disease such as: angina pectoris, myocardial infarction, stroke, transient ischemic attack, peripheral vascular disease.
- •17) History of immunodeficiency diseases, including a positive HIV (ELISA and Western blot) test result.
- •18) Chronic infection with Hepatitis B (HBV) or Hepatitis C (HCV).
- •19) Score yes” on item 4 or item 5 of the Suicidal Ideation section of the C-SSRS, if this ideation occurred in the past 6 months, or yes” on any item of the Suicidal Behavior section, except for the Non-Suicidal Self-Injurious Behavior” (item
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