Stopping Benzodiazepines and Related Molecules Among Elderly Living in Residential Institutions (BenzoFree)
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|ClinicalTrials.gov Identifier: NCT02715440|
Recruitment Status : Completed
First Posted : March 22, 2016
Last Update Posted : March 22, 2016
Intervention randomized controlled open study with 2 parallel arms . The objective of this study is to evaluate the feasibility of stopping the benzodiazepines treatment in elderly living in nursing homes.
It will check that the judgment of these molecules has no pejorative effect on sleep or behavior of residents and does not induce withdrawal syndrome. Two patient groups will be constituted. One will begin a gradual withdrawal of benzodiazepines in six weeks. The other group will continue his treatment and withdrawal will be proposed after 8 weeks by his general practitioner (delayed intervention).
Effects on sleep will be assessed by wrist actimetry for 10 weeks and a sleep diary . The repercussions of withdrawal on behavior will be rated by the NPI scale.
|Condition or disease||Intervention/treatment||Phase|
|Elderly Drug Therapy Syndrome Substance-Related Disorders Substance Withdrawal Syndrome||Drug: Immediate intervention||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||116 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||Stopping Benzodiazepines and Related Molecules Among Elderly Living in Residential Institutions: Feasibility and Impact on Sleep and Behavior|
|Study Start Date :||February 2012|
|Actual Primary Completion Date :||December 2014|
|Actual Study Completion Date :||August 2015|
Experimental: Immediate intervention
Gradual withdrawal of benzodiazepines or related drugs : 25% reduction of the benzodiazepines dose or related drugs every 2 weeks during nine weeks in order to stop the treatment .
Drug: Immediate intervention
Gradual withdrawal of benzodiazepines or related drugs
Other Name: benzodiazepines or related drugs cessation
No Intervention: Delayed intervention
usual care without intervention
- Feasibility: Percentage of residents exposed to benzodiazepines & related molecules (B& RM) and eligible but refusing to participate in the trial included proportion of patients whose attending physician refuses to stop B & RM [ Time Frame: screening ]Percentage of residents exposed to benzodiazepines & related molecules (B& RM) and eligible but refusing to participate in the trial included proportion of patients whose attending physician refuses to stop B & RM
- No negative impact on sleep assessed by NPI scale [ Time Frame: evolution between day 0 and week 10 ]sleep disturbances severity assessed by the score of the item to sleep NPI-scale.
- No negative impact on the behavior [ Time Frame: evolution between day 0 and week 10 ]The severity of agitation and aberrant motor behavior assessed by scores on items agitation / aggression and aberrant behavior of the same scale
- Average time of sleep [ Time Frame: each week up to week 10 ]assessed using the sleep diary and wrist actimetry.
- Average number of nighttime awakenings [ Time Frame: each week up to week 10 ]assessed using the sleep diary and wrist actimetry.
- Severity of behavioral problems assessed by NPI scale [ Time Frame: baseline, on the 5th weeks, on the10th weeks ]assessed by scores on other items of NPI-scale.
- Proportion of patients with adverse events (including withdrawal symptoms). [ Time Frame: on the 5th weeks, on the10th weeks ]
- Proportion of patients discharged from study. [ Time Frame: between day 0 and week 10 ]
- Proportion of patients in the immediate intervention in which the Benzodiazepines and related drugs are stopped [ Time Frame: on the 10th weeks and after one year. ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02715440
|Principal Investigator:||Joël Belmin, PUPH||00 331 49 59 45 65|