Division on Substance Abuse, New York State Psychiatric Institute, Columbia University College of Physicians and Surgeons, Department of Psychiatry, 1051 Riverside Drive, Unit 120, New York, NY 10032, USA.
Drug Alcohol Depend. 2012 Nov 1;126(1-2):206-15. doi: 10.1016/j.drugalcdep.2012.05.013. Epub 2012 Jun 20.
The extent of prescription opioid abuse has led to the development of formulations that are difficult to crush. The purpose of the present studies was to examine whether experienced prescription opioid abusers (individuals using prescription opioids for non-medical purposes regardless of how they were obtained) were able to prepare a formulation of oxymorphone hydrochloride ER 40 mg designed to be crush-resistant (DCR) for intranasal (study 1) or intravenous abuse (study 2), utilizing a non-crush-resistant formulation of oxymorphone (40 mg; OXM) as a positive control.
No drug was administered in these studies. Participants were provided with DCR and OXM tablets in random order and asked to prepare them for abuse with tools/solutions that they had previously requested. The primary outcome for study 1 was particle size distribution, and the primary outcome for study 2 was percent yield of active drug in the extracts. Other descriptive variables were examined to better understand potential responses to these formulations.
Fewer DCR than OXM particles were smaller than 1.705 mm (9.8% vs. 97.7%), and thus appropriate for analyses. Percent yield of active drug in extract was low and did not differ between the two formulations (DCR: 1.95%; OXM: 1.29%). Most participants were not willing to snort (92%) or inject (84%) the tampered products. Participants indicated that they found less relative value in the DCR than the OXM formulation across both studies.
These data suggest that the oxymorphone DCR formulations may be a promising technology for reducing opioid abuse.
处方类阿片类药物滥用的程度导致了难以粉碎的制剂的发展。本研究的目的是检验经验丰富的处方类阿片类药物滥用者（无论以何种方式获得，均将处方类阿片类药物用于非医疗目的的个体）是否能够制备盐酸羟考酮控释制剂 40mg（设计为抗粉碎的，即 DCR），用于鼻内（研究 1）或静脉内滥用（研究 2），利用盐酸羟考酮的非抗粉碎制剂（40mg；OXM）作为阳性对照。
这些研究中未给予任何药物。参与者随机提供 DCR 和 OXM 片剂，并要求他们使用之前要求的工具/溶液来准备滥用。研究 1 的主要结果是粒度分布，研究 2 的主要结果是提取物中活性药物的产率。还检查了其他描述性变量，以更好地了解对这些制剂的潜在反应。
少于 OXM 颗粒的 DCR 颗粒小于 1.705mm（9.8%比 97.7%），因此适合分析。提取物中活性药物的产率较低，且两种制剂之间无差异（DCR：1.95%；OXM：1.29%）。大多数参与者不愿意鼻吸（92%）或注射（84%）篡改后的产品。参与者表示，在两项研究中，他们发现 DCR 制剂的相对价值低于 OXM 制剂。
这些数据表明，羟考酮 DCR 制剂可能是减少阿片类药物滥用的一种有前途的技术。
