High-dose baclofen for the treatment of alcohol addiction * A double-blind, randomized, placebo-controlled study - High-dose baclofen for the treatment of alcohol addiction

Academisch Medisch Centrum0 个研究点目标入组 130 人开始时间: 待定最近更新: 2024年4月29日

适应症

试验速览

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•- Male and Female patients, aged between 18-70 years
•- Participants have a current DSM-IV diagnosis of alcohol dependence
•- Participants sign a witnessed informed consent
•- Participants have a breath alcohol concentration lower than 0.05 at the screening visit
•- Participants must have been drinking * 14 drinks (female) or * 21 drinks (males) on average per week over a consecutive 30-day period in the 90-day period prior to the start of the study and have two or more days of heavy drinking (5 drinks for females, 6 drinks for males) in the 90-day period prior to the start of the study
•- Participants must have had a minimum of 96 hours of abstinence prior to the start of the medication
•- Participants can be abstinent for a maximum of 21 days prior to the start of the study
•- Participants must be able to speak and understand dutch
•- Participants provide an identified locator person that can be contacted during the study in the event of loss of contact

•- Participants with severe psychiatric disorders (schizophrenia, schizoaffective disorder, bulimia/anorexia, dementia, or ADHD requiring medication) except for depression, bipolar disorder and anxiety
•- Participants with serious medical illnesses (Parkinson*s disease, gastric ulcer, duodenal ulcer, cerebrovascular disease, respiratory insufficiency, hepatic or renal insufficiency, and epilepsy)
•*- Patients who are treated with anti-hypertensiva
•- Participants who are at risk of suicide evaluated by the suicidality module of M.I.N.I.
•- Participants who have a cognitive impairment which is likely to interfere with the understanding of the study and its procedures
•- Participants with a diagnosis of dependence on any drugs except for nicotine, cannabis, alcohol and caffeine, if alcohol dependence doesn*t represent the main addiction
•- Participants who are/or could be pregnant or nursing infants.
•- Participants who intend to engage in additional treatment for alcohol-related problems (except for self-help treatments which are not considered as formal treatment).
•- Participants with current or recent (3 month prior to the start of the study) treatment with anti-craving medication (acamprosate, naltrexone, disulfiram, or topiramate)
•- Participants who have had more than seven days of inpatient treatment for substance use disorder in the 30 days prior to the start of the study.
•- Participants who have used baclofen in the last 30 days

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