verslavingsziektes benzodiazepine withdrawal
Conditions
Interventions
All patients are given a subcutaneous flumazenil infusion with a rate of 4 mg/
24 hrs during 4-6 days. A low dose of oxazepam will be given orally during the
first three nights. Use of all other ben
flumazenil
withdrawal
Sponsors
Radboud Universitair Medisch Centrum
Eligibility
Age
18 Years to 64 Years
Inclusion criteria
Inclusion criteria: • A primary diagnosis of benzodiazepine dependence with an average daily dose of at least 30 mg of diazepam or equivalent according table 2 OR A diagnosis of benzodiazepine dependence with an average daily dose of at least 30 mg of diazepam or an equivalent with a co-morbid diagnosis of alcohol or cannabis dependence. Prior to the baseline measurement and flumazenil infusion patients must be abstinent from alcohol and cannabis for at least two months. • Age between 21 and 65 years. • Participants should master Dutch language sufficiently to provide informed consent and participate in all measurements (including self report questionnaires). • Motivation for and availability of a regular treatment after the detoxification procedure at a regional (addiction) care facility.
Exclusion criteria
Exclusion criteria: • History of epilepsy or IEDs on EEG or other serious neurological disorders; • History of a serious medical condition, including heart disease (myocardial infarction or arrhythmias), lung disease (COPD gold stage II or higher), acute liver or kidney disease (indexed by ASAT ALAT max three times the norm or increased Creatinine/Ureum); • Diagnosis of a current severe psychiatric disorder (psychosis, mania, severe depression); • Diagnosis of a primary organic sleep disorders e.g. hypersomnia, disorders of the sleep wake schedule and sleep apnoea; • A positive urine screening for cocaine, heroin, amphetamine, ecstasy, cannabis, opiates, buprenorphine and methadone;
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Subjective Withdrawal Scale (in dutch: Subjectieve Onthoudings Schaal (SOS)) Objective Withdrawal Scale (in dutch: objective Onthoudings Schaal (OOS). BWSQ (Benzodiazepine Withdrawal Symptom Questionnaire) Registration of any adverse event Registration of Intericatal Epileptiform Discharges (IEDs) during two nights with a combined Electroencephalography (EEG)/ Polysomnography (PSG) | — |
Secondary
| Measure | Time frame |
|---|---|
| Spielberger State-Trait Anxiety Inventory Mini International Neuropsychiatric Interview (MINI) SCL-90R Emotional Stroop Test Pittsburgh Sleep Quality Index (PSQI) Sleep Wake Diary Registration of sleep during two nights with a combined Electroencephalography (EEG)/ Polysomnography (PSG) psychomotor vigilance test (PVT) A 5-point Likert scale questionnaire on the burden and recommendation of the treatment to others and preparedness to repeat the treatment if needed Abstinence rates after infusion, one month and three month EuroQuol 5d (EQ-5d) | — |
Countries
The Netherlands
Outcome results
None listed