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

Recruitment & Eligibility

Status: Completed

Sex: Not specified

Target Recruitment: 130

Inclusion Criteria

- 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

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)
*- 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

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>The primary outcome measure is the time to the first relapse. Lapse is defined<br /><br>as the first occurrence of alcohol intake of more than four standard drinks on<br /><br>one occasion for females and five standard drinks on one occasion for males.<br /><br>Relapse will be defined as the second occurrence of alcohol intake of more than<br /><br>four standard drinks per occasion for females and five standard drinks per<br /><br>occasion for males. </p><br>

Secondary Outcome Measures

Name	Time	Method
<p>Key secondary substance related outcome measures 16 weeks are:<br /><br>- cumulative abstinence duration percentage (CADP). CADP is an estimate of<br /><br>the proportion of abstinent days over 16 weeks<br /><br>- number of drinks (total alcohol consumption (TAC) during 16 weeks)<br /><br>- number of heavy drinking days<br /><br><br /><br>Other secondary outcome measures after 4 weeks and 16 weeks are:<br /><br>- number of drinks<br /><br>- the level of craving<br /><br>- the presence of alcohol dependence according to DSM-IV<br /><br>- cognitive biases<br /><br>- level of anxiety<br /><br>- sleep pattern<br /><br>- compliance with therapy (pill counts and attendance at outpatient therapy<br /><br>sessions)<br /><br>- biological markers of heavy alcohol consumption (carbohydrate deficient<br /><br>transferring, CDT)<br /><br>- the use of other drugs<br /><br>- the general quality of life<br /><br>- adverse events </p><br>