Benzodiazepine agonist treatment for patients with benzodiazepine dependence undergoing opioid agonist treatment: a study protocol for the randomized controlled trial BMX-BAR
2024

Benzodiazepine Treatment for Patients with Opioid Dependence

Sample size: 108 publication 10 minutes Evidence: moderate

Author Information

Author(s): Fatemeh Chalabianloo, Lars Thore Fadnes, Jörg Assmus, Jon Mordal, Kristin K. Solli, Kjetil S. Dale, Christina D. Andersen, Silvia Zavenova, Beathe H. Rønning, Andreas W. Blomkvist, Martin Ryssdal, Wasifa S. J. Butt, Anne Marciuch, Anne G. Ørmen, Christian Ohldieck, Else-Marie Løberg, Kjell Arne Johansson, Svanhild Mellingen, Maria K. Olsvold, Mette H. Nordbotn, Beate H. Trettenes, Tine U. Berger, Kristin Sannerud, Christine Sundal, Marianne Pierron, Henriette Moe, Zainab Alibhai, Karoline N. Helgøy, Susanne Vedaa, Line Holtan, Heidi F. Kristiansen, Jeanine T.H. Karlsen, Richard Kaspersen, Linn C.W. Digranes

Primary Institution: Department of Addiction Medicine, Haukeland University Hospital, Bergen, Norway

Hypothesis

Stabilizing treatment with prescribed benzodiazepines will significantly reduce the use of illicit benzodiazepines among patients with long-lasting benzodiazepine dependence undergoing opioid agonist treatment.

Conclusion

The study aims to determine if benzodiazepine agonist treatment is more effective than tapering in reducing illicit benzodiazepine use among patients undergoing opioid agonist treatment.

Supporting Evidence

  • Participants will be randomly assigned to either a stabilizing treatment or a tapering treatment.
  • The study will assess the use of illicit benzodiazepines through urine tests.
  • Secondary outcomes include mental health symptoms and quality of life.
  • The trial is the first of its kind to investigate benzodiazepine agonist treatment in this population.
  • Participants will receive psychosocial follow-up in accordance with clinical practice.
  • The study aims to improve health and quality of life for patients with concurrent benzodiazepine and opioid dependence.
  • Recruitment started in September 2022 and is expected to be completed by December 2025.
  • The study is registered with the EU trial number EudraCT: 2021–004981-37.

Takeaway

This study is trying to find out if giving patients prescribed benzodiazepines helps them use fewer illegal drugs compared to just taking them off the medication.

Methodology

A randomized controlled trial comparing a 26-week benzodiazepine stabilizing treatment with a 20-week tapering treatment.

Potential Biases

Potential for self-reported data inaccuracies regarding illicit drug use.

Limitations

The study may have challenges with blinding and risks of using illicitly acquired medications.

Participant Demographics

Adults undergoing opioid agonist treatment with benzodiazepine dependence.

Digital Object Identifier (DOI)

10.1186/s13063-024-08692-8

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