Slow continuous subcutaneous flumazenil infusion for benzodiazepine dependence: a pilot study

Phase 2

Recruiting

Conditions: verslavingsziektes
benzodiazepine withdrawal

Registration Number: NL-OMON41934

Lead Sponsor: Radboud Universitair Medisch Centrum

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Recruiting

Sex: Not specified

Target Recruitment: 30

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;

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>Subjective Withdrawal Scale (in dutch: Subjectieve Onthoudings Schaal (SOS))<br /><br>Objective Withdrawal Scale (in dutch: objective Onthoudings Schaal (OOS).<br /><br>BWSQ (Benzodiazepine Withdrawal Symptom Questionnaire)<br /><br>Registration of any adverse event<br /><br>Registration of Intericatal Epileptiform Discharges (IEDs) during two nights<br /><br>with a combined Electroencephalography (EEG)/ Polysomnography (PSG)</p><br>

Secondary Outcome Measures

Name	Time	Method
<p>Spielberger State-Trait Anxiety Inventory<br /><br>Mini International Neuropsychiatric Interview (MINI)<br /><br>SCL-90R<br /><br>Emotional Stroop Test<br /><br>Pittsburgh Sleep Quality Index (PSQI)<br /><br>Sleep Wake Diary<br /><br>Registration of sleep during two nights with a combined Electroencephalography<br /><br>(EEG)/ Polysomnography (PSG)<br /><br>psychomotor vigilance test (PVT)<br /><br>A 5-point Likert scale questionnaire on the burden and recommendation of the<br /><br>treatment to others and preparedness to repeat the treatment if needed<br /><br>Abstinence rates after infusion, one month and three month<br /><br>EuroQuol 5d (EQ-5d)</p><br>