[Pharmacologic criteria for medical substitution in opiate dependence].
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).
Montastruc
Jean-Louis
JL
Service de Pharmacologie Clinique, Centre d'Evaluation et d'Informations sur la Pharmacodépendance (CEIP), CHU de Toulouse, Toulouse, France. montastruc@cict.fr
Arnaud
Philippe
P
Barbier
Catherine
C
Berlin
Ivan
I
Gatignol
Chantal
C
Haramburu
Françoise
F
Lagier
Georges
G
Lapeyre-Mestre
Maryse
M
Mallaret
Michel
M
Micaleff
Joëlle
J
D003061:Codeine / Q000627:therapeutic use; D005059:Euphoria / Q000187:drug effects; D006801:Humans; D008691:Methadone / Q000627:therapeutic use; D009020:Morphine / Q000627:therapeutic use; D009294:Narcotics / Q000008:administration & dosage / Q000493:pharmacokinetics / Q000627:therapeutic use*; D009293:Opioid-Related Disorders / Q000534:rehabilitation*; D011788:Quality of Life
D009294:Narcotics; D009020:Morphine; D008691:Methadone; D003061:Codeine