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Therapie. 2003 Mar-Apr;58(2):123-5. doi: 10.2515/therapie:2003017.

[Pharmacologic criteria for medical substitution in opiate dependence].

Therapie

[Article in French]
Jean-Louis Montastruc, Philippe Arnaud, Catherine Barbier, Ivan Berlin, Chantal Gatignol, Françoise Haramburu, Georges Lagier, Maryse Lapeyre-Mestre, Michel Mallaret, Joëlle Micaleff

Affiliations

  1. Service de Pharmacologie Clinique, Centre d'Evaluation et d'Informations sur la Pharmacodépendance (CEIP), CHU de Toulouse, Toulouse, France. [email protected]

PMID: 12942851 DOI: 10.2515/therapie:2003017

Abstract

Our goal was to establish new pharmacological criteria for a drug to be used in the treatment of opioid dependence. We propose the following six pharmacodynamic and pharmacokinetic criteria: (i) the same pharmacodynamic properties as the drug being substituted; (ii) a long duration of action (minimum 24 hours, not requiring several daily doses) in order to prevent fluctuations in effect and especially withdrawal symptoms; (iii) few euphoric effects together with a minimal reinforcing effect for the drug itself and other drugs; (iv) oral or sublingual administration without any special affinity for other routes, especially the intravenous; (v) a New Drug Application (NDA) in this indication, after submission of a dossier including both clinical randomised comparative trials and security data; and (vi) compatibility with a socially satisfying quality of life. These criteria were applied to methadone, buprenorphine and other drugs that were proposed in the treatment of opioid dependence (such as morphine or codeine).

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