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

Academic Medical Centrum0 sites250 target enrollmentFebruary 24, 2012

Overview

No summary available.

Registry

who.int

Start Date

February 24, 2012

End Date

TBD

Last Updated

13 years ago

Study Type

Interventional clinical trial of medicinal product

Sex

All

Sponsor

Academic Medical Centrum

•?\- Male and Female patients, aged between 18\-60 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 study
•?\- 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
•Are the trial subjects under 18? no

•\- 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)
•\- 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