Alcohol dependence
Conditions
Interventions
Trade Name: Baclofen
Product Name: Baclofen
Product Code: RVG 21993=12153
Pharmaceutical Form: Tablet
INN or Proposed INN: BACLOFEN
CAS Number: 1134-47-0
Other descriptive name: Lioresal
Concentration
Sponsors
Academic Medical Centrum
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: ?- 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 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 250 F.1.3 Elderly (>=65 years) no F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: - 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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: The primary goal of the present study is to examine the efficacy of high dose baclofen for the treatment of patients with AD in a double-blind, randomized, placebo controlled study. ;Secondary Objective: Furthermore, as a secondary study objective, factors, which may predict the treatment response of baclofen are investigated. In order to assess which patients benefit the most of the treatment with baclofen, it is proposed to examine the role of: - anxiety - motives to drink - personality - family history and age of onset of AD - genetic endowments ;Primary end point(s): Based on earlier literature it is expected that 70 % of patients treated with baclofen will achieve and maintain abstinence throughout the experimental period, compared to 20 % of the patients in the placebo condition.;Timepoint(s) of evaluation of this end point: after 18 weeks | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): It is expected that there will be a decrease of anxiety, caused by baclofen. Furthermore, a greater number of participants with coping motives will maintain abstinence compared to patients with enhancement motives. Furthermore, it is expected that particular genes predict treatment response. ;Timepoint(s) of evaluation of this end point: after 18 weeks | — |
Countries
Netherlands
Contacts
Public ContactClinical Trials Information Baclofe
University of Amsterdam
Outcome results
None listed