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Brief Motivational Intervention (BMI) on the Deprescription of Benzodiazepines and Related Substances in Adult Chronic Drug Users

Study acronym: BENZ_HALTE
StatusRecruiting
PhaseNot applicable
Started
View on ClinicalTrials.gov ↗
Trial flagged as At Risk
Primary completion moved at least 10 months later May 31, 2026 → Apr 3, 2027
See other at-risk trials from University Hospital, Grenoble

Record History

See every version on ClinicalTrials.gov ↗

  1. Primary completion pushed from May 31, 2026 to Apr 3, 2027 Show 8 more changesShow less
    • Primary endpoints: details revised at 2 of 2 entries
    • Study completion pushed from Dec 1, 2026 to Apr 3, 2027
    • Start date: Dec 2, 2024 to Dec 3, 2024
    • Eligibility criteria expanded, about 15 words
    • Secondary endpoints: details revised at 9 of 9 entries
    • Study description revised
    • Site details revised at 2 of 20 sites
    • Publications: details revised at 39 of 42 entries
  2. Trial status: Not Yet Recruiting to Recruitingv5 Show 4 more changesShow less
    • Start date changed from estimate of Sep 1, 2024 to Dec 2, 2024
    • Primary completion date: Feb 15, 2026 to May 31, 2026
    • Study completion date: Aug 1, 2026 to Dec 1, 2026
    • Study sites revised (20)
  3. Primary endpoints revised (2)
    • Secondary endpoints revised (9)
    v4
  4. Primary endpoints revised (2)
    • Secondary endpoints: details revised at 4 of 9 entries
    v3
  5. Primary endpoints revised (2)
    • Secondary endpoints revised (9)
    • Study description expanded, about 1 word
    v2
  6. Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
We hypothesise that a short-term intervention by dispensing pharmacists is feasible and relatively easy to implement, and that it could have an impact on the deprescribing of BZD/Z in adult patients. Two primary objectives will be evaluated in a sequential hierarchical manner, with two primary endpoints analysed one after the other, without alpha risk adjustment, but the second can only be analysed if the null hypothesis is rejected for the first: 1. Evaluate the impact of brief motivational intervention (BMI) on reducing the daily dose of BZD/Z prescribed at 6 months (superiority hypothesis) compared with the usual practice of dispensing BZD/Z in pharmacies. 2. Evaluate the impact of BMI on clinical worsening at 6 months (non-inferiority hypothesis) in comparison with the usual practice of dispensing BZD/Z in pharmacies.
Trial Details
NCT Number NCT06446349
Lead Sponsor University Hospital, Grenoble
Conditions
(from sponsor)		 Benzodiazepine Withdrawal
Related terms Substance-Related Disorders
Enrollment 300 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov