Detoxification of high dose Benzo with flumazenil infusio

Conditions: Patients diagnosed with benzodiazepine dependence with an average daily dose of at least 30 mg of diazepam equivalence.
MedDRA version: 18.0Level: LLTClassification code 10004099Term: Barbiturate and similarly acting sedative or hypnotic dependence, continuous useSystem Organ Class: 100000004873
Therapeutic area: Psychiatry and Psychology [F] - Mental Disorders [F03]

Registration Number: EUCTR2014-000420-15-NL

Lead Sponsor: Radboud University Medical Centre, department of Psychiatry

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Authorised-recruitment may be ongoing or finished

Sex: All

Target Recruitment: Not specified

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.

Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 30
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range

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 clinical trial of medicinal product

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main 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.<br>;Primary end point(s): Only mild and transient withdrawal symptoms during and after detoxification, <br>Without the occurrence of any adverse events.<br>Without IEDs on EEG/PSG recording. <br>;Timepoint(s) of evaluation of this end point: during detoxification an after one month and three month.;Secondary Objective: Secondary goals of the study are to explore <br>1)the effect of flumazenil detoxification on anxiety levels during and after detoxification, <br>2)the effects of flumazenil detoxification on sleep quality during and after detoxification, <br>3)patient satisfaction with flumazenil detoxification, <br>4)efficacy of flumazenil detoxification.<br>

Secondary Outcome Measures

Name	Time	Method
Secondary end point(s): After detoxification<br>1)Decreased anxiety levels,<br>2)Improve sleep quality, <br>3)A satisfactory method for detoxification reviewing the detoxified patients,<br>4)Show 100% completers, 75% abstinence after 3-months and improved quality of life.<br>;Timepoint(s) of evaluation of this end point: during detoxification and after one and three month.