The primary objective is to demonstrate that detoxification of benzodiazepines in high-dose benzodiazepine dependent patients using continuous subcutaneous infusion of flumazenil is feasible and safe.Secondary goals of the study are to explore 1)…
ID
Source
Brief title
Condition
- Other condition
Synonym
Health condition
verslavingsziektes
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
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 outcome
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)
Background summary
In the Netherlands, about 200,000 people are benzodiazepine dependent resulting
in a reduced quality of life and increased risk of accidents. Detoxification of
high-dose benzodiazepines by tapering is long, difficult for the patient and is
often not successful (<30% abstinence after one year). Flumazenil infusion
could solve this problem. In Australia and Italy about 1500 people have been
treated for about four days with a low dose of flumazenil. All participants
finished the detoxification with generally few withdrawal symptoms.
In this study, 30 patients with high-dose benzodiazepine will be treated with
flumazenil. Not only withdrawal symptoms and safety (EEG recordings) will be
examined but also the effects on anxiety and sleep. In addition, research is
being done on the effectiveness after three months. If the results are positive
then offers this perspective for all people with benzodiazepine dependence.
Study objective
The primary objective is to demonstrate that detoxification of benzodiazepines
in high-dose benzodiazepine dependent patients using continuous subcutaneous
infusion of flumazenil is feasible and safe.
Secondary goals of the study are to explore
1) Percentage completers and abstinence rate after three month.
2) The effect of flumazenil detoxification on anxiety and sleep during and
after detoxification.
3) Patient satisfaction of flumazenil detoxification.
Study design
Open label pilot study
Intervention
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 benzodiazepines stops with the start of
the infusion.
Study burden and risks
The burden will consist of four days of subcutaneous infusion, completing
various questionnaires, performing computer tasks, twice taking an EEG during
sleep, and two additional visits to the outpatient clinic of the Radboud
University Nijmegen Medical Centre. There may be an increased risk of seizures
in respect to regular treatment. The advantages that are opposite are: a
shorter hospital stay of one week instead of about six weeks, accompanied by
fewer withdrawal symptoms, and a greater chance of successful cessation of
benzodiazepines.
Reinier Postlaan 10
Nijmegen 6525 EX
NL
Reinier Postlaan 10
Nijmegen 6525 EX
NL
Listed location countries
Age
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
• 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
Recruitment
Medical products/devices used
Followed up by the following (possibly more current) registration
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Other (possibly less up-to-date) registrations in this register
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In other registers
| Register | ID |
|---|---|
| EudraCT | EUCTR2014-000420-15-NL |
| CCMO | NL49414.091.15 |