How to Ease the Withdrawal of Tranquilizers Among Older Consumers?

NCT02281175 | Completed DMC

• 1 other identifier: CRIUGM-003
• Study Type: interventional
• Target: 114
• Locations: 1 country
• Sites: 1

Brief 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

Keywords

Benzodiazepine withdrawal; PASSE-65+ program; Psychosocial (non-pharmacological) intervention; Cognitive-Behavioral Therapy (CBT); Older adults

Outcome Measures

Primary Outcomes (1)

• Change in consumed BZD (diazepam equivalent) dose

  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.

  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)

Secondary Outcomes (6)

• Assessment of withdrawal symptoms

  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)

• Evaluation of self-competence OU self-confidence towards change in benzodiazepine use

  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)

• Estimation of attitudes towards benzodiazepine consommation

  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)

• Symptoms of anxiety OU worry assessment

  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)

• Measurement of depression symptoms

  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)

Other Outcomes (2)

• Economic cost analysis

  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

  12 months before the beginning of the intervention, during the intervention period and 12 months after the end of intervention

Study Arms (3)

No contact intervention

NO INTERVENTION

Informative document that proposes a 12-week self-withdrawal grid

a weekly physician intervention

ACTIVE COMPARATOR

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

Behavioral: a weekly physician intervention

psychosocial intervention

EXPERIMENTAL

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

Interventions

Psychosocial intervention BEHAVIORAL

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

psychosocial intervention

a weekly physician intervention BEHAVIORAL

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

a weekly physician intervention

Eligibility Criteria

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

You may qualify if:

• 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.

You may not qualify if:

• 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.).

Sponsors & Collaborators

• Centre de Recherche de l'Institut Universitaire de Geriatrie de Montreal: lead
• Canadian Institutes of Health Research (CIHR): collaborator
• Universite du Quebec en Outaouais: collaborator
• Université de Montréal: collaborator
• Université de Sherbrooke: collaborator
• Laval University: collaborator

Study Sites (1)

Centre de Recherche de l'Institut Universitaire de Geriatrie de Montreal

Montreal, Quebec, H3W 1W5, Canada

Location

Related Publications (2)

• Allary A, Proulx-Tremblay V, Belanger C, Hudon C, Marchand A, O'Connor K, Perodeau G, Roberge P, Tannenbaum C, Vasiliadis HM, Desrosiers C, Cruz-Santiago D, Grenier S. Psychological predictors of benzodiazepine discontinuation among older adults: Results from the PASSE 60. Addict Behav. 2020 Mar;102:106195. doi: 10.1016/j.addbeh.2019.106195. Epub 2019 Oct 31.

  PMID: 31838367 DERIVED

• Proulx-Tremblay V, Allary A, Payette MC, Benyebdri F, Boudreau MM, Bernard C, Leveille V, Desrosiers C, Cruz-Santiago D, Gagne MH, Bertrand JA, Grenier S. Social support and sleep quality in older benzodiazepine users. Aging Ment Health. 2020 Sep;24(9):1437-1443. doi: 10.1080/13607863.2019.1594167. Epub 2019 Apr 12.

  PMID: 30977682 DERIVED

Related Links

• Lab website (in french only)

MeSH Terms

Conditions

Substance-Related Disorders

Interventions

Psychosocial Intervention

Condition Hierarchy (Ancestors)

Chemically-Induced Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Psychotherapy; Behavioral Disciplines and Activities

Study Officials

• Sébastien Grenier, Ph.D.

  Centre de Recherche de l'Institut Universitaire de Geriatrie de Montreal

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Research Associate Professor

Study Record Dates

• First Submitted: October 22, 2014
• First Posted: November 3, 2014
• Study Start: August 1, 2014
• Primary Completion: July 1, 2018
• Study Completion: July 1, 2018
• Last Updated: March 31, 2022

Record last verified: 2022-03

Locations

CA (1)