Abuse liability assessment of hydrocodone under current draft regulatory guidelines

详细信息    查看全文

• 作者：David V. Gauvin ; ^{david.gauvin@mpiresearch.com" class="auth_mail" title="E-mail the corresponding author} ; Margaret McComb ; Robert Code ; Jill A. Dalton ; Theodore J. Baird
• 关键词：Hydrocodone ; Self administration ; Drug discrimination ; Drug dependence ; Discontinuation syndrome ; Withdrawal ; Morphine ; Oxycodone ; Abuse liability ; Methods
• 刊名：Journal of Pharmacological and Toxicological Methods
• 出版年：2015
• 出版时间：September-October 2015
• 年：2015
• 卷：75
• 期：Complete
• 页码：118-129
• 全文大小：1110 K

文摘

The abuse liability of hydrocodone was assessed in male Sprague–Dawley rats under the European Medicines Agency, the International Commission on Harmonisation, and the U.S. Food & Drug Administration draft guidelines for the non-clinical investigation of the dependence potential of medicinal products.

Methods

Self-administration, drug discrimination, and repeat-dose two week dependence liability studies were conducted to compare hydrocodone to the prototypical opiates, morphine and oxycodone.

Results

Hydrocodone was self-administered, produced an opiate-like subjective discriminative generalization profile and produced a significant discontinuation syndrome following abrupt treatment cessation that was quantitatively and qualitatively similar to morphine and/or oxycodone.

Conclusion

Hydrocodone has abuse liability more similar to Schedule II opiates than other Schedule III compounds currently controlled under the U.S. Controlled Substance Act.