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Stopping Benzodiazepines and Related Molecules Among Elderly Living in Residential Institutions (BenzoFree)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02715440
Recruitment Status : Completed
First Posted : March 22, 2016
Last Update Posted : March 22, 2016
Sponsor:
Information provided by (Responsible Party):
Assistance Publique - Hôpitaux de Paris

Brief Summary:

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

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 116 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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

Arm Intervention/treatment
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



Primary Outcome Measures :
  1. 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

  2. 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.

  3. 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


Secondary Outcome Measures :
  1. Average time of sleep [ Time Frame: each week up to week 10 ]
    assessed using the sleep diary and wrist actimetry.

  2. Average number of nighttime awakenings [ Time Frame: each week up to week 10 ]
    assessed using the sleep diary and wrist actimetry.

  3. 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.

  4. Proportion of patients with adverse events (including withdrawal symptoms). [ Time Frame: on the 5th weeks, on the10th weeks ]
  5. Proportion of patients discharged from study. [ Time Frame: between day 0 and week 10 ]
  6. 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. ]


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Ages Eligible for Study:   70 Years and older   (Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Residents aged 70 or older and institutionalized for over a month
  • Receiving one or more benzodiazepines and related drugs for over 30 days;
  • Corresponding to stop aspects of benzodiazepines and related drugs as recent best practice guidelines by the French health authority (HAS)
  • Signature of informed consent by the patient attended or not his guardian, the guardian or a relative;
  • General practitioner agreeing to adhere to recommendations.

Exclusion Criteria:

  • psychiatric pathology,
  • epilepsy
  • end of life situation
  • Refusal to participate (or representative if he is unable to consent).

Information from the National Library of Medicine

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


Sponsors and Collaborators
Assistance Publique - Hôpitaux de Paris
Investigators
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Principal Investigator: Joël Belmin, PUPH 00 331 49 59 45 65
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Responsible Party: Assistance Publique - Hôpitaux de Paris
ClinicalTrials.gov Identifier: NCT02715440    
Other Study ID Numbers: P081245
2011-001609-28 ( EudraCT Number )
First Posted: March 22, 2016    Key Record Dates
Last Update Posted: March 22, 2016
Last Verified: February 2016
Keywords provided by Assistance Publique - Hôpitaux de Paris:
Benzodiazepines
drugs
withdrawal
nursing home
elderly
therapy elderly
Adverse Effect
pharmacokinetics
Decreased Drug Tolerance
Additional relevant MeSH terms:
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Syndrome
Substance-Related Disorders
Substance Withdrawal Syndrome
Disease
Pathologic Processes
Chemically-Induced Disorders
Mental Disorders