Stopping Benzodiazepines and Related Molecules Among Elderly Living in Residential Institutions

NCT02715440 | Completed

• 2 other identifiers: P0812452011-001609-28
• Study Type: interventional
• Target: 116
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Elderly; Drug Therapy Syndrome; Substance-Related Disorders; Substance Withdrawal Syndrome

Keywords

Benzodiazepines; drugs; withdrawal; nursing home; elderly; therapy elderly; Adverse Effect; pharmacokinetics; Decreased Drug Tolerance

Outcome Measures

Primary Outcomes (3)

• 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

  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

  screening

• No negative impact on sleep assessed by NPI scale

  sleep disturbances severity assessed by the score of the item to sleep NPI-scale.

  evolution between day 0 and week 10

• No negative impact on the behavior

  The severity of agitation and aberrant motor behavior assessed by scores on items agitation / aggression and aberrant behavior of the same scale

  evolution between day 0 and week 10

Secondary Outcomes (6)

• Average time of sleep

  each week up to week 10

• Average number of nighttime awakenings

  each week up to week 10

• Severity of behavioral problems assessed by NPI scale

  baseline, on the 5th weeks, on the10th weeks

• Proportion of patients with adverse events (including withdrawal symptoms).

  on the 5th weeks, on the10th weeks

• Proportion of patients discharged from study.

  between day 0 and week 10

Study Arms (2)

Immediate intervention

EXPERIMENTAL

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

Delayed intervention

NO INTERVENTION

usual care without intervention

Interventions

Immediate intervention DRUG

Gradual withdrawal of benzodiazepines or related drugs

Also known as: benzodiazepines or related drugs cessation

Immediate intervention

Eligibility Criteria

• Age: 70 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

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

Sponsors & Collaborators

• Assistance Publique - Hôpitaux de Paris: lead

MeSH Terms

Conditions

Substance-Related Disorders; Substance Withdrawal Syndrome

Interventions

Benzodiazepines

Condition Hierarchy (Ancestors)

Chemically-Induced Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Benzazepines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds

Study Officials

• Joël Belmin, PUPH

  00 331 49 59 45 65

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 24, 2016
• First Posted: March 22, 2016
• Study Start: February 1, 2012
• Primary Completion: December 1, 2014
• Study Completion: August 1, 2015
• Last Updated: March 22, 2016

Record last verified: 2016-02