EUCTR2017-004706-18-NO招募中1 期
ong acting naltrexone for opioid addiction: the importance of mental, physical and societal factors for sustained abstinence and recovery (NaltRec)
Akershus University Hospital0 个研究点目标入组 150 人开始时间: 2018年1月29日最近更新:
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 招募中
- 发起方
- 入组人数
- 150
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
- 性别
- All
入选标准
- •1. Signed informed consent and expected cooperation of the patients for the treatment and follow up must be obtained and documented according to ICH GCP, and national/local regulations.
- •2. Male or female at 18-65 years
- •3. Has a current diagnosis of opioid dependence, based on the criteria of the DSM-V (304.00) as confirmed by the Mini-International Neuropsychiatric Interview (MINI)
- •4. Is voluntarily seeking treatment for opioid dependence
- •5. Completing a stay in a controlled environment with restricted access to substances of abuse with a minimum duration of 7 (seven) days (waived for OMT controls)
- •6. Is enrolled in the Norwegian national opioid maintenance treatment (OMT) program ‘LAR’ before discharge from a controlled environment. For subjects who complete & submit their LAR application while in a controlled environment, the investigator may complete enrolment data collection while awaiting response on LAR admission.
- •7. If female and of childbearing potential, must agree to use an highly effective acceptable method of contraception for the duration of the study (waived for OMT controls)
- •8. Capable of understanding and complying with the study procedures
- •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 145
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 5
排除标准
- •1. Pregnancy (ie, positive urine and/or serum pregnancy test) and/or currently breastfeeding
- •2. Clinically significant medical condition or observed abnormalities that need medical attention and follow-up (including: severe hepatic (Child-Turcotte-Pugh level C) or renal failure, clinically significant symptoms of progressive Acquired Immunodeficiency Syndrome (AIDS))
- •3. Severe psychiatric disorder (including: current or recurrent affective disorders with suicidal behavior, psychotic disorders) that need medical attention and follow-up
- •4. Use of any excluded medication at screening or anticipated/required use during the study period (including: requiring treatment with opioid medications other than investigational products)
- •5. Known intolerance and/or hypersensitivity to XR-NTX, carboxymethylcellulose, or polylactide-co-polymers (PLG) or any other components of the diluent (waived for OMT controls).
- •6. Alcoholism defined by the criteria in DSM V
- •7. Serious respiratory debilitation.
- •8. Any finding that in the view of the PI would compromise the subject’s ability to fulfill the protocol visit schedule or visit requirements
- •9. Employment by Alkermes or Reckitt-Benckiser or Curida AS (permanent, temporary contract worker, or designee responsible for the conduct of the study) or immediate family of an Alkermes or Reckitt-Benckiser or Curida employee.
- •10. Abnormal laboratory assessments. If pathological values, coordinating investigator will decide if the subject is eligible for participation in the study
- •11. Not participating in any other trial that might affect the current study
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