|- candidate number||13491|
|- NTR Number||NTR3681|
|- ISRCTN||ISRCTN wordt niet meer aangevraagd.|
|- Date ISRCTN created|
|- date ISRCTN requested|
|- Date Registered NTR||29-okt-2012|
|- Secondary IDs||2012_054 / 2011-004142-17 METC|
|- Public Title||High-dose baclofen for the treatment of alcohol addiction.|
|- Scientific Title||HIgh-dose baclofen for the treatment of alcohol addiction: A double-blind, randomized, placebo-controlled study.|
|- Healt Condition(s) or Problem(s) studied||Alcohol dependence|
|- Inclusion criteria||1. Male and Female patients, aged between 18-60 years;|
2. Participants have a current DSM-IV diagnosis of alcohol dependence;
3. Participants sign a witnessed informed consent;
4. Participants have a breath alcohol concentration lower than 0.5 % at the screening visit;
5. 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 (five drinks females, six drinks males) in the 90-day period prior to the start of the study;
6. Participants must have had a minimum of 96 hours of abstinence prior to the start of the medication;
7. Participants can be abstinent for a maximum of 21 days prior to the start of the study;
8. Participants must be able to speak and understand Dutch;
9. Participants provide an identified person that can be contacted during the study in the event of loss of contact and can give information about the patientís alcohol use.
|- Exclusion criteria||1. Participants with current severe psychiatric disorders (schizophrenia, schizoaffective disorder,bulimia/anorexia, or ADHD requiring medication) besides depression, bipolar disorder and anxiety;|
2. Participants with serious medical illnesses (Parkisonís disease, gastric ulcer, duodenal ulcer, cerebrovascular disease, respiratory insufficiency, hepatic or renal insufficiency, and epilepsy);
3. Patients who are treated with anti-hypertensive medication;
4. Participants who are at risk of suicide evaluated by the suicidality module of the M.I.N.I.;
5. Participants who have a cognitive impairment which is likely to interfere with the understanding of the study and its procedures;
6. Participants with a diagnosis of dependence on any drugs except for nicotine, cannabis, alcohol and caffeine, if alcohol dependence doesnít represent the main addiction;
7. Participants who are/or could be pregnant or nursing infants;
8. Participants who intend to engage in additional treatment for alcohol-related problems. Self-help treatments are not considered formal treatment;
9. Participants with current or recent (3 months prior to the start of the study) treatment with anti-craving medication (acamprosate, naltrexone, disulfiram, or topiramate);
10. Participants who have had more than seven days of inpatients treatment for substance use disorder in the 30 days prior to the start of the study;
11. Participants who have prior use of baclofen in the last 30 days.
|- mec approval received||yes|
|- multicenter trial||yes|
|- Type||2 or more arms, randomized|
|- planned startdate ||5-nov-2012|
|- planned closingdate||1-jul-2015|
|- Target number of participants||160|
|- Interventions||In this study baclofen or placebo will be orally administered for the duration of 18 weeks. Participants will be included in one of the three groups: A high-dose baclofen group, a low-dose baclofen group or a placebo group. |
|- Primary outcome||The primary outcome measure is abstinence, measured in time to the first relapse. |
|- Secondary outcome||Key secondary outcome measures are the total alcohol consumption and the number of heavy drinking days.|
Other secondary outcome measures are craving, depression, anxiety, side effects and biological markers.
|- Timepoints||1. Baseline (prior to start of the intervention);|
2. During intervention (26 days after start);
3. After the end of the intervention (16 weeks after baseline);
4. 6-month follow-up.
Outcome measures are assessed with questionnaires.
|- Trial web site||www.baclofenstudie.com|
|- status||open: patient inclusion|
|- CONTACT FOR PUBLIC QUERIES|| |
|- CONTACT for SCIENTIFIC QUERIES||Prof. Reinout Wiers|
|- Sponsor/Initiator ||Academic Medical Center (AMC), Amsterdam|
(Source(s) of Monetary or Material Support)
|Amsterdams Fonds voor Verslavingsonderzoek|
|- Brief summary||N/A|
|- Main changes (audit trail)||27-jan-2015: Changes: |
- Intervention: "Since less participants than expected could be included, it was decided to exclude the low-dose baclofen groep and continue with two arms: the placebo group and the high-dose baclofen group."
- Timepoints: 6 month follow-up cancelled.
|- RECORD||29-okt-2012 - 28-jan-2015|