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High-dose baclofen for the treatment of alcohol addiction.


- candidate number13491
- NTR NumberNTR3681
- ISRCTNISRCTN wordt niet meer aangevraagd.
- Date ISRCTN created
- date ISRCTN requested
- Date Registered NTR29-okt-2012
- Secondary IDs2012_054 / 2011-004142-17 METC
- Public TitleHigh-dose baclofen for the treatment of alcohol addiction.
- Scientific TitleHIgh-dose baclofen for the treatment of alcohol addiction: A double-blind, randomized, placebo-controlled study.
- ACRONYM
- hypothesisN/A
- Healt Condition(s) or Problem(s) studiedAlcohol dependence
- Inclusion criteria1. 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 criteria1. 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 receivedyes
- multicenter trialno
- randomisedyes
- masking/blindingDouble
- controlPlacebo
- groupParallel
- Type2 or more arms, randomized
- Studytypeintervention
- planned startdate 5-nov-2012
- planned closingdate
- Target number of participants225
- InterventionsIn 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 outcomeThe primary outcome measure is abstinence, measured in time to the first relapse.
- Secondary outcomeKey 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.
- Timepoints1. 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 siteN/A
- statusplanned
- CONTACT FOR PUBLIC QUERIES
- CONTACT for SCIENTIFIC QUERIESProf. Reinout Wiers
- Sponsor/Initiator Academic Medical Center (AMC, Amsterdam)
- Funding
(Source(s) of Monetary or Material Support)
Amsterdams Fonds voor Verslavingsonderzoek
- PublicationsN/A
- Brief summaryN/A
- Main changes (audit trail)
- RECORD29-okt-2012 - 12-nov-2012


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