NALOXONE SUMMARY
Naloxone hydrochloride, an opioid antagonist, is a synthetic congener of oxymorphone. In structure it differs from oxymorphone in that the methyl group on the nitrogen atom is replaced by an allyl group.
Naloxone hydrochloride injection is indicated for the complete or partial reversal of opioid depression, including respiratory depression, induced by natural and synthetic opioids including propoxyphene, methadone, and certain mixed agonist-antagonist analgesics: nalbuphine, pentazocine, butorphanol, and cyclazocine.
Naloxone hydrochloride is also indicated for the diagnosis of suspected or known acute opioid overdosage. Naloxone hydrochloride injection may be useful as an adjunctive agent to increase blood pressure in the management of septic shock (see
CLINICAL PHARMACOLOGY:
Adjunctive Use in Septic Shock
).
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NEWS HIGHLIGHTS
Published Studies Related to Naloxone
Pharmacological challenge with naloxone and cue exposure in alcohol dependence:
results of a randomized, double-blind placebo-controlled trial. [2013]
dependency was reported... CONCLUSIONS: We could not replicate the result, that blocking of the endogenous
A randomised controlled trial of sublingual buprenorphine-naloxone film versus
tablets in the management of opioid dependence. [2013]
(substance use, psychosocial function)... CONCLUSIONS: The study demonstrated dose equivalence and comparable clinical
A comparison of oxycodone prolonged-release vs. oxycodone + naloxone
prolonged-release after laparoscopic hysterectomy. [2013]
for short-term post-operative pain management... CONCLUSION: Addition of naloxone to oxycodone PR tablets in a pain regimen
A randomized, double-blind, active-controlled, double-dummy, parallel-group study
to determine the safety and efficacy of oxycodone/naloxone prolonged-release
tablets in patients with moderate/severe, chronic cancer pain. [2012]
prolonged-release tablets (OxyPR) in patients with moderate/severe cancer pain... CONCLUSIONS: OXN PR provides superior bowel function in cancer pain patients,
Adjunctive counseling during brief and extended buprenorphine-naloxone treatment for prescription opioid dependence: a 2-phase randomized controlled trial. [2011.12]
CONTEXT: No randomized trials have examined treatments for prescription opioid dependence, despite its increasing prevalence. OBJECTIVE: To evaluate the efficacy of brief and extended buprenorphine hydrochloride-naloxone hydrochloride treatment, with different counseling intensities, for patients dependent on prescription opioids... CONCLUSIONS: Prescription opioid-dependent patients are most likely to reduce opioid use during buprenorphine-naloxone treatment; if tapered off buprenorphine-naloxone, even after 12 weeks of treatment, the likelihood of an unsuccessful outcome is high, even in patients receiving counseling in addition to SMM. Trial Registration clinicaltrials.gov Identifier: NCT00316277.
Clinical Trials Related to Naloxone
Effect of High Dose Naloxone on Secondary Hyperalgesia [Completed]
Recent studies have focused on the role of endogenous opioids on central sensitization.
Central sensitization is known to be impaired or altered in chronic pain conditions, as
fibromyalgia or chronic tension headache.
Animal studies have shown reinstatement of mechanical hypersensitivity following naloxone
administration after resolution of an injury. This suggests latent sensitization.
In the present study, investigators hypothesize that naloxone (2 mg/kg) can reinstate
secondary hyperalgesia 168 hours after a first-degree burn-injury. Investigators aim
therefore to show that latent sensitization is present in humans and is modulated by
endogenous opioids.
Comparison of Two Naloxone Infusion Rates on the Postoperative Recovery of Patients Undergoing Spine Fusion Surgery [Recruiting]
There will be two groups in this study: one group will be given the standard infusion of
naloxone, a drug which helps reduce side effects from opioids needed after surgery, and the
other group will receive a higher dose. The trial is designed to determine if a higher dose
of naloxone infusion will reduce side effects from opioid therapy in patients who have
undergone spine fusion for scoliosis.
Nasal Naloxone for Narcotic Overdose [Not yet recruiting]
The goal of this study is to determine if nasal naloxone is inferior to standard care for
naloxone administration in a pre-hospital setting. Ambulance squads in Adams, Clermont, and
Scioto counties in southern Ohio will be randomized to provide either standard care or nasal
(IN) naloxone as the initial response to a suspected opioid overdose. Standard care includes
administration of naloxone by intravenous (IV), intramuscular (IM) or intraosseus (IO)
methods.
Subjective Analgesic Effects of Naloxone and Virtual Reality [Active, not recruiting]
This study is designed to test a specific hypothesis exploring the neurophysiologic
mechanism(s) that underlie the pain- relieving effects of immersive Virtual Reality (VR) as
a non-pharmacologic pain management technique, using healthy volunteers experiencing
carefully controlled thermal and/or electrical pain in the laboratory. Over the past
decade, our research group has performed a series of NIH-funded investigations of VR
analgesia - in both the clinical pain and laboratory pain settings - demonstrating its
clinical efficacy and safety. In the current study we will test pharmacologic manipulation
of VR analgesia (with the opioid analgesia antagonist naloxone). We anticipate that this
theoretical work will provide a foundation for future clinical applications of immersive VR
- whether used alone or in combination with other analgesic agents - and make immersive VR a
more effective and more widely used analgesic tool for the treatment of clinical pain.
Our previous work with immersive VR indicates that its use during a painful event can reduce
subjective pain reports during both acute clinical and laboratory pain by 20-50% [1].
Furthermore, we have shown that effective VR analgesia is associated with reduced
pain-related brain activity that is quantitatively and qualitatively comparable to
clinically relevant doses of systemic opioid analgesics [2]. The laboratory pain protocol
proposed in the current application is identical to the UW HSD-approved protocol used in our
previous studies (#25296 - "Reducing Brief Thermal and Electrical Pain"). What is
specifically different in the current protocol is the use of naloxone to determine whether
VR analgesia operates through an endogenous opioid-dependent mechanism or not. The results
of this study will not only suggest the mechanism of action of VR analgesia, but also allow
us to more effectively apply immersive VR analgesia in the clinically pain setting through
its thoughtful combination with well-established pharmacologic analgesic techniques, such as
opioid analgesia administration.
The specific aim of this study and the hypothesis it tests are as follows: To determine the
extent to which subjective analgesic effects of VR analgesia are inhibited by opioid
receptor antagonism with naloxone. Hypothesis - VR analgesia will not be inhibited by
systemic opioid receptor antagonism, suggesting that VR analgesia is not mediated by release
of endogenous opiates and/or by activation of opioid-dependent descending central nervous
system pathways.
Reversal of Ketamine Pharmacodynamic Effects With Naloxone [Recruiting]
The purpose of this study is to determine whether the analgetic and other effects effect of
ketamine are partly mediated through opioid receptors
Reports of Suspected Naloxone Side Effects
Confusional State (5),
Accidental Overdose (5),
Bradykinesia (5),
Drug Withdrawal Syndrome (5),
Bradyphrenia (5),
Dyskinesia (4),
Pulmonary Oedema (4),
Toxicity TO Various Agents (4),
Anxiety (4),
Diarrhoea (4), more >>
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