How to Ease the Withdrawal of Tranquilizers Among Older Consumers?

NCT02281175 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 114

Last updated 2022-03-31

No results posted yet for this study

Summary

Benzodiazepines (BZD) are widely used to treat anxiety, insomnia, and depression. These drugs can have very serious side effects if they are taken over a long period of time. In addition to stability, memory, concentration, vigilance, and attention impairments, long-term use of BZD is also associated with an increased in hypertension incidence, urinary incontinence, coronary artery disease, and renal complications. There are growing evidences that long-term BZD use causes physical and psychological dependence as evidenced by the withdrawal syndrome.

The recommended strategy by physicians to facilitate the withdrawal of BZD is to gradually reduce the medication, either by replacing the BZD by another with a longer half-life, or by the gradual dose reduction. Unfortunately, the success of such a procedure is low as up to 80% of people who try to quit, relapse due to the intolerance of withdrawal symptoms. Therefore, it is important to find new strategies to overcome the withdrawal difficulties.

The aim of this study is to test the effectiveness of a novel psychosocial intervention called PASSE-65+ to facilitate the benzodiazepine withdrawal in the older users, thus providing a new therapeutic tool to physician.

Conditions

  • Drug Dependence

Interventions

BEHAVIORAL

Psychosocial intervention

Based on a cognitive-behavioral approach, the psychosocial intervention (PASSE-65+) is specifically designed to help older BZD users to better manage their withdrawal symptoms, to stop their medication, and to improve their general psychological well-being

BEHAVIORAL

a weekly physician intervention

Informative document + 12 meetings (once a week; 30 minutes) with a physician who will supervise the gradual withdrawal

Sponsors & Collaborators

  • Canadian Institutes of Health Research (CIHR)

    collaborator OTHER_GOV
  • Universite du Quebec en Outaouais

    collaborator OTHER
  • Université de Montréal

    collaborator OTHER
  • Université de Sherbrooke

    collaborator OTHER
  • Laval University

    collaborator OTHER
  • Centre de Recherche de l'Institut Universitaire de Geriatrie de Montreal

    lead OTHER

Principal Investigators

  • Sébastien Grenier, Ph.D. · Centre de Recherche de l'Institut Universitaire de Geriatrie de Montreal

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
65 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2014-08-31
Primary Completion
2018-07-31
Completion
2018-07-31

Countries

  • Canada

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02281175 on ClinicalTrials.gov