EUCTR2016-004710-95-SE进行中（未招募）1 期
Extended-release injectable suspension naltrexone (XR-NTX) as an adjunt pharmacotherapy for prevention of substance use in patients with SUD who are currently in treatment for ADHD: A multicenter randomized placebo-controlled trial. - REPAS (Relapse prevention in ADHD/SUD)
Beroendecentrum Stockholm0 个研究点目标入组 128 人开始时间: 2017年1月10日最近更新:
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 128
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
- 性别
- All
入选标准
- •1) Adult male or female aged 18-70 years
- •2) Written, informed consent to participate
- •3) Fulfil DSM-5 criteria for ADHD
- •4) Ongoing central stimulant pharmacotherapy (e.g. methylphenidate,
- •amphetamines) for ADHD,
- •irrespective of duration or dose, formulation or brand.
- •5) Fulfil DSM-5 criteria for alcohol use disorder, and/or stimulant use
- •disorder, and/or opioid use
- •disorder, having a minimum of 2 relapses (=drug use on two separate
- •days, and/or two heavy drinking
- •days) in the last 30 days as defined by self-report and/or by urine
- •6) One negative urine sample (amphetamine, cocaine, opiates, THC and
- •benzodiazepines) and
- •negative alcohol breathalyser test within four days prior to the day of
- •7) One negative urine sample for opiates (dip stick test) immediately
- •prior to administering the first
- •dose of study medication
- •8) Address and telephone in the metropolitan area of each participating
- •centre, respectively, where the
- •participant can be reached
- •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 128
- •F.1.3 Elderly (>=65 years) no
- •F.1.3.1 Number of subjects for this age range
排除标准
- •1) Current DSM-5 diagnosis of severe opioid substance use disorder,
- •2) Manifestation of withdrawal symptoms or reports of current withdrawal symptoms of opioids
- •3) Current psychiatric condition considered by the study physician to be severe and/or unstable (e.g., psychosis, schizophrenia, bipolar, suicidal or homicidal)
- •4) Known or suspected use of any opioid medication or illicit opiates in the last 7 days prior to inclusion
- •5) Ongoing benzodiazepine pharmacotherapy (medically motivated doses for e g withdrawal treatment during the trial do not constitute a reason for exclusion)
- •6) Somatic disorder (e.g., cancer, seizure disorder, severe hypertension and liver cirrhosis) determined to be serious in the clinical judgement of the study physician
- •7) Acute hepatitis or liver damage as evidenced by serum aspartate (AST) or alanine aminotransferase (ALT) concentration greater than three times the upper normal reference range, or serum bilirubin greater than 10% above the upper normal limit.
- •8) Female subjects who are pregnant or lactating or of child bearing potential who are not using acceptable methods of birth control. Specified as combined hormonal contraception associated with inhibition of ovulation (orally, intravaginal or transdermal), progesterone-only hormonal contraception associated with inhibition of ovulation (oral, injectable,
- •implantable), intrauterine device (IUD), intrauterine hormone-releasing system (IUS), bilateral tubal occlusion, vasectomized partner, condom or sexual abstinence.
- •9) Known hypersensitivity to naltrexone, polylactide-co-glycolide (PLG), carboxymethylcellulose or any other compounds of the diluent
- •10) Likely to receive opioid analgesics in the next 6-months associated with possible or scheduled surgery or procedure
- •11) Use of an investigational agent in the last 30 days
- •11) Subjects with a body abnormality precluding the use of the customized needle for intramuscularinjection, based on clinical judgement
研究者
相似试验
进行中（未招募）
不适用
Extended Release Naltrexone for Treating Amphetamine Dependence in IcelandAmphetamine dependenceEUCTR2009-013647-10-ISational Institute on Drug Abuse (NIDA)
进行中（未招募）
1 期
Extended-release Pharmacotherapy for Opioid Use Disorder (EXPO)Opiod addictionMedDRA version: 23.1Level: LLTClassification code 10013658Term: Drug addictionSystem Organ Class: 10037175 - Psychiatric disordersMedDRA version: 20.0Level: SOCClassification code 10037175Term: Psychiatric disordersSystem Organ Class: 10037175 - Psychiatric disordersEUCTR2018-004460-63-GBSouth London and Maudsley NHS Foundation Trust600
招募中
不适用
ow Dose Naltrexone for the induction of remission in patients with mild to moderate Crohn’s Diseasethat failed conventional treatmentNL-OMON21939ZonMW122
尚未招募
2 期
ow Dose Naltrexone for the induction of remission in patients with mild to moderate Crohn*s Disease that failed conventional treatmentinflammatory bowel disease10017969Crohn's diseaseNL-OMON52463Erasmus MC, Universitair Medisch Centrum Rotterdam122
已完成
1 期
Naltrexone for Opioid Dependent Released Human Immunodeficiency Virus Positive (HIV+) Criminal Justice PopulationsHIVAIDSOpioid DependenceDrug DependenceNCT01246401Yale University151