EUCTR2018-000048-24-SE进行中（未招募）1 期
A RANDOMIZED DOUBLE-BLIND PLACEBO-CONTROLLED MULTICENTER TRIAL ON THE EFFICACY OF VARENICLINE AND BUPROPION, IN COMBINATION AND ALONE, FOR THE TREATMENT OF ALCOHOL USE DISORDER - The COMB study
Sahlgrenska University Hospital/VGR0 个研究点目标入组 380 人开始时间: 2018年10月24日最近更新:
适应症
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
- 380
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
- •Inclusion criteria
- •1) Signed informed consent
- •2) Blood alcohol level below <0.1‰ (0.1 g/L) at signing informed consent
- •3) 25-70 years of age at screening
- •4) Moderate and severe AUD according to DSM-V (meeting =4 out of 11 criteria)
- •5) B-PEth levels of =0.5 µmol/L at screening visit (visit 1)
- •6) Continuous high alcohol consumption over the last 3 months prior to screening as defined by at least 2 HDD per week on a typical week.
- •7) Available phone number for contact
- •8) Ability to speak and write in Swedish
- •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 320
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 60
排除标准
- •1) Total abstinence between screening and randomization visit
- •2) Treatment of alcohol withdrawal within 30 days of study initiation
- •3) Pharmacological treatment within 3 months of study initiation and during the study period that may affect alcohol consumption, including but not exclusive to, varenicline, bupropion, disulfiram, acamprosate, naltrexone, nalmefene, baclofen, topiramate, ondansetron, mirtazapine, methylphenidate, dexamphetamine, atomoxetine, pregabalin, buprenorphine and methadone
- •4) Non-pharmacological treatment within 3 months of study initiation and during the study
- •period that may affect alcohol consumption
- •5) Current continuous use of antidepressants, opioid analgesics, benzodiazepines, zopiclone, zolpidem, hydroxizin, alimemazin, propiomazin, or other sedatives. (The sporadic use of these compounds is accepted.)
- •6) Any concurrent medication that may affect the results of the trial or is considered to
- •compromise the safety of the participants in the trial. (See SmPCs for possible interactions.)
- •7) Laboratory hepatic values of >3 times the upper limit of the normal range, creatinine clearence <30 ml/min, or other clinically significant abnormalities in the screening laboratory values
- •8) Blood pressure =180/110 at screening
- •9) Pregnancy, breast-feeding and for premenopausal women, not using one of the contraceptive methods oral contraceptive, intrauterine contraceptive device (copper or hormonal) or subcutaneous inplant.
- •10) Diabetes mellitus type 1 and diabetes mellitus type 2 in need of insulin treatment
- •11) Any current psychiatric or somatic disorder or condition that may affect assessments or compromise participant’s safety during the trial
- •12) ASRS- v1.1, part A score =4 in the marked cut-off section
- •13) MADRS score = 20
- •14) Current depression that is not mild (mild depression is accepted)
- •15) Suicidality
- •16) Current illicit drug use based on urine-toxicity test and DUDIT
- •17) History of delirium tremens or abstinence-induced seizures within 5 years of study initiation
- •18) Epilepsia or seizures other than alcohol-induced, lifetime
- •19) Severe sleep disturbances
- •20) Need of alcohol detoxification
- •21) Living conditions not appropriate to fulfill study requirements
- •22) Use of herbal drugs/tea and supplementations possibly affecting outcome or safety
- •23) Previous randomization in this trial or participation in another trial within 3 months of enrolment into this trial.
- •24) Additional factors that render the participant unable to complete the study, as judged by the investigator
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