BACLOFEN FOR IMPROVING BENZODIAZEPINE TITRATION IN BENZODIAZEPINE DEPENDENCE. BABET

Conditions

addictology, Psychiatrics disorders

Brief summary

Difference in total benzodiazepine consumption, in mg-diazepam, between the 28 days before inclusion in the clinical trial and the last 28 days the last 28 days before visit 5 on Day 62/64 of randomisation

Detailed description

Frequency of serious and non-serious adverse events of special interest, and frequency of all-cause study discontinuations., Frequency of benzodiazepine discontinuation at the last visit of the treatment period (self-report and urine test); Benzodiazepine withdrawal severity score assessed by the Clinical Institute Withdrawal Assessment of Benzodiazepine (CIWA-B), Craving score assessed by the Visual Analog Scale (VAS), Anxiety symptoms assessed by the State Trait Inventory Anxiety (STAI-Y), Depression score assessed by the Montgomery-Åsberg Depression Rating Scale (MADRS), Subjective sleep quality assessed by the Pittsburgh Sleep Quality Index (PSQI), Quality of life (SF-12 v2).

Related papers

No related papers found yet.

Interventions

DRUG-

DRUGZOPICLONE

DRUGCellulose microcristalline

DRUGZOLPIDEM

DRUGBACLOFEN

Eligibility

Sex/Gender

All

Age

18 Years to 64 Years

Design outcomes

Primary

Measure	Time frame
Difference in total benzodiazepine consumption, in mg-diazepam, between the 28 days before inclusion in the clinical trial and the last 28 days the last 28 days before visit 5 on Day 62/64 of randomisation	—

Secondary

Measure	Time frame
Frequency of serious and non-serious adverse events of special interest, and frequency of all-cause study discontinuations., Frequency of benzodiazepine discontinuation at the last visit of the treatment period (self-report and urine test); Benzodiazepine withdrawal severity score assessed by the Clinical Institute Withdrawal Assessment of Benzodiazepine (CIWA-B), Craving score assessed by the Visual Analog Scale (VAS), Anxiety symptoms assessed by the State Trait Inventory Anxiety (STAI-Y), Depression score assessed by the Montgomery-Åsberg Depression Rating Scale (MADRS), Subjective sleep quality assessed by the Pittsburgh Sleep Quality Index (PSQI), Quality of life (SF-12 v2).	—

Measure

Time frame

Frequency of serious and non-serious adverse events of special interest, and frequency of all-cause study discontinuations., Frequency of benzodiazepine discontinuation at the last visit of the treatment period (self-report and urine test); Benzodiazepine withdrawal severity score assessed by the Clinical Institute Withdrawal Assessment of Benzodiazepine (CIWA-B), Craving score assessed by the Visual Analog Scale (VAS), Anxiety symptoms assessed by the State Trait Inventory Anxiety (STAI-Y), Depression score assessed by the Montgomery-Åsberg Depression Rating Scale (MADRS), Subjective sleep quality assessed by the Pittsburgh Sleep Quality Index (PSQI), Quality of life (SF-12 v2).

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Countries

France

Outcome results

None listed