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How to Ease the Withdrawal of Tranquilizers Among Older Consumers?

This study is currently recruiting participants.
Verified August 2016 by Dr Sébastien Grenier, Centre de Recherche de l'Institut Universitaire de Geriatrie de Montreal
Sponsor:
ClinicalTrials.gov Identifier:
NCT02281175
First Posted: November 3, 2014
Last Update Posted: August 5, 2016
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. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
Collaborators:
Canadian Institutes of Health Research (CIHR)
Universite du Quebec en Outaouais
Université de Montréal
Université de Sherbrooke
Laval University
Information provided by (Responsible Party):
Dr Sébastien Grenier, Centre de Recherche de l'Institut Universitaire de Geriatrie de Montreal
  Purpose

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.


Condition Intervention
Drug Dependence Behavioral: Psychosocial intervention Behavioral: a weekly physician intervention

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: The Effectiveness of a Novel Psychosocial Intervention "Programme d'Aide au Succès du Sevrage " (PASSE-65+) Designed to Help Older Benzodiazepine Users to Gradually Wean Their Medication

Further study details as provided by Dr Sébastien Grenier, Centre de Recherche de l'Institut Universitaire de Geriatrie de Montreal:

Primary Outcome Measures:
  • Change in consumed BZD (diazepam equivalent) dose [ Time Frame: 1 month before the beginning of the intervention and 2-14 days, 3 months and 12 months after the end of intervention (a total of four assessments) ]
    Comparison between the average dose of BZD (diazepam equivalent) consumed during the month preceding the beginning of intervention and the one consumed between 2-14 days , 3 months and 12 months after the end of intervention.


Secondary Outcome Measures:
  • Assessment of withdrawal symptoms [ Time Frame: 1 month before the beginning of the intervention and 2-14 days, 3 months and 12 months after the end of intervention (a total of four assessments) ]
    Benzodiazepine Withdrawal Symptom Questionnaire (BWSQ)

  • Evaluation of self-competence OU self-confidence towards change in benzodiazepine use [ Time Frame: 1 month before the beginning of the intervention and 2-14 days, 3 months and 12 months after the end of intervention (a total of four assessments) ]
    Perceived Competence Scale (PCS)

  • Estimation of attitudes towards benzodiazepine consommation [ Time Frame: 1 month before the beginning of the intervention and 2-14 days, 3 months and 12 months after the end of intervention (a total of four assessments) ]
    Attitudes Towards Tranquilizer Use Questionnaire (ATTUQ)

  • Symptoms of anxiety OU worry assessment [ Time Frame: 1 month before the beginning of the intervention and 2-14 days, 3 months and 12 months after the end of intervention (a total of four assessments) ]
    Penn State Worry Questionnaire (PSWQ)

  • Measurement of depression symptoms [ Time Frame: 1 month before the beginning of the intervention and 2-14 days, 3 months and 12 months after the end of intervention (a total of four assessments) ]
    Beck Depression Inventory-II (BDI-II)

  • Assessment of sleep quality [ Time Frame: 1 month before the beginning of the intervention and 2-14 days, 3 months and 12 months after the end of intervention (a total of four assessments) ]
    Pittsburgh Sleep Quality Index (PSQI)


Other Outcome Measures:
  • Economic cost analysis [ Time Frame: 12 months before the beginning of the intervention, during the intervention and 12 months after the end of intervention ]
  • Cost analysis related to the health system and to the patient [ Time Frame: 12 months before the beginning of the intervention, during the intervention period and 12 months after the end of intervention ]

Estimated Enrollment: 75
Study Start Date: August 2014
Estimated Study Completion Date: December 2017
Estimated Primary Completion Date: August 2017 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
No Intervention: No contact intervention
Informative document that proposes a 12-week self-withdrawal grid
Active Comparator: a weekly physician intervention
Informative document + 12 meetings (once a week; 30 minutes) with a physician who will supervise the gradual withdrawal
Behavioral: a weekly physician intervention
Informative document + 12 meetings (once a week; 30 minutes) with a physician who will supervise the gradual withdrawal
Experimental: psychosocial intervention
Informative document + 12 meetings (once a week; 30 minutes) with a physician who will supervise the gradual withdrawal + psychosocial intervention (PASSE-65+ program: 12 sessions over 16 weeks)
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

  Show Detailed Description

  Eligibility

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   65 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Be aged 65 years and older;
  • To consume benzodiazepine for at least two years (even if consumption is not continuous);
  • Want to quit benzodiazepine use.

Exclusion Criteria:

  • Living a difficult situation that requires specific interventions (e.g. bereavement or death, a recent breakup or suicidal thoughts);
  • Alcohol or illicit drugs addiction (other than benzodiazepine);
  • BZD use for medical reasons (e.g. epilepsy);
  • Be unable to complete the questionnaires or to attend meetings for any reason (e.g. Loss of vision, severe arthritis, cognitive impairment, etc.).
  Contacts and Locations
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): NCT02281175


Contacts
Contact: Fethia Benyebdri, Ph.D. 15143403540 ext 4788 fethia.benyebdri@criugm.qc.ca
Contact: Sébastien Grenier, Ph.D. 15143403540 ext 4782 sebastien.grenier@umontreal.ca

Locations
Canada, Quebec
Centre de Recherche de l'Institut Universitaire de Geriatrie de Montreal Recruiting
Montréal, Quebec, Canada, H3W 1W4
Contact: Fethia Benyebdri, Ph..D.    15143403540 ext 4788    fethia.benyebdri@criugm.qc.ca   
Principal Investigator: Sébastien Grenier, Ph.D.         
Sponsors and Collaborators
Centre de Recherche de l'Institut Universitaire de Geriatrie de Montreal
Canadian Institutes of Health Research (CIHR)
Universite du Quebec en Outaouais
Université de Montréal
Université de Sherbrooke
Laval University
Investigators
Principal Investigator: Sébastien Grenier, Ph.D. Centre de Recherche de l'Institut Universitaire de Geriatrie de Montreal
  More Information

Additional Information:
Responsible Party: Dr Sébastien Grenier, Research Associate Professor, Centre de Recherche de l'Institut Universitaire de Geriatrie de Montreal
ClinicalTrials.gov Identifier: NCT02281175     History of Changes
Other Study ID Numbers: CRIUGM-003
First Submitted: October 22, 2014
First Posted: November 3, 2014
Last Update Posted: August 5, 2016
Last Verified: August 2016

Keywords provided by Dr Sébastien Grenier, Centre de Recherche de l'Institut Universitaire de Geriatrie de Montreal:
Benzodiazepine withdrawal
PASSE-65+ program
Psychosocial (non-pharmacological) intervention
Cognitive-Behavioral Therapy (CBT)
Older adults

Additional relevant MeSH terms:
Substance-Related Disorders
Chemically-Induced Disorders
Mental Disorders