Articles: opioid.
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Multicenter Study Clinical Trial
Pharmacokinetics of hydrocodone/acetaminophen combination product in children ages 6-17 with moderate to moderately severe postoperative pain.
Lortab® Elixir, a proprietary combination product containing hydrocodone and acetaminophen, is approved in the US for the treatment of moderate to moderately severe pain in children. Despite this approval, pediatric pharmacokinetic data using this product have not been previously published. Using a single-dose open-label study approach, we evaluated the pharmacokinetics, tolerability, and safety of this product in 17 healthy children 6-17 years of age. ⋯ We found adjustment of hydrocodone and acetaminophen dose by body surface area to be more optimal than body weight-based dose adjustments for achieving similar systemic exposure in children and adults. However, body weight-based hydrocodone and acetaminophen dosing regimens provided close approximation of adult exposures in pediatric patients with approximately 22% to 24% lower hydrocodone and acetaminophen dose/BW-normalized AUC in pediatric patients compared to adults. Finally, the adverse event profile in our pediatric cohort was consistent with that expected of opioid-naive subjects receiving opioid-combination therapy.
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Addictive behaviors · Feb 2015
Randomized Controlled Trial Multicenter StudyOpioid withdrawal, craving, and use during and after outpatient buprenorphine stabilization and taper: a discrete survival and growth mixture model.
Most patients relapse to opioids within one month of opioid agonist detoxification, making the antecedents and parallel processes of first use critical for investigation. Craving and withdrawal are often studied in relationship to opioid outcomes, and a novel analytic strategy applied to these two phenomena may indicate targeted intervention strategies. ⋯ Generally, participants with lower baseline levels and greater decreases in craving and withdrawal during stabilization combined with slower craving and withdrawal rebound during buprenorphine taper remained opioid-free longer. This exploratory work expanded on the importance of monitoring craving and withdrawal during buprenorphine induction, stabilization, and taper. Future research may allow individually tailored and timely interventions to be developed to extend time-to-first opioid use.
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Expert Opin Pharmacother · Feb 2015
ReviewAbuse-deterrent formulations: part 2: commercial products and proprietary technologies.
Increased misuse and abuse of prescription pain medications has driven extensive research and development to produce what are best known as abuse-deterrent formulations (ADFs). The ADFs are intended to prevent, impede or discourage physical and chemical tampering while still being able to provide safe and accurate delivery of an abusable medication for therapeutic benefit. ⋯ Despite the introduction of a wide range of formulation and technology interventions with different deterrence potential, the progression of these technologies seems to be moving from inhibiting only one type of abuse to stopping multiple types of tampering methods. Information on inherent strengths and weaknesses of various formulations can be utilized in the development of more robust and resistant ADF in the future.
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Little is known about variability in primary care providers' (PCPs) adherence to opioid-monitoring guidelines for patients. We examined variability of adherence to monitoring guidelines among PCPs and ascertained the relationship between PCP adherence and opioid misuse by their patients. We included primary care patients receiving long-term opioids (≥3 prescriptions within 6 months) for chronic noncancer pain and PCPs with ≥4 eligible patients. ⋯ Primary care providers varied significantly in adherence to opioid prescription guidelines. Increased patient risk was associated with increased monitoring and with greater misuse. Future work should study system-level interventions to enable clinical monitoring and support opioid guideline adherence.
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Opioid overdose and mortality have increased at an alarming rate prompting new public health initiatives to reduce drug poisoning. One initiative is to expand access to the opioid antidote naloxone. Naloxone has a long history of safe and effective use by organized healthcare systems and providers in the treatment of opioid overdose by paramedics/emergency medicine technicians, emergency medicine physicians and anesthesiologists. ⋯ Contacts are trained on overdose recognition, rescue breathing and administration of naloxone by intramuscular injection or nasal spraying of the injection prior to the arrival of emergency medical personnel. The safety profile of naloxone in traditional medical use must be considered in this new context of outpatient prescribing, dispensing and treatment of overdose prior to paramedic arrival. New naloxone delivery products are being developed for this prehospital application of naloxone in treatment of opioid overdose and prevention of opioid-induced mortality.