NEWS HIGHLIGHTSMedia Articles Related to Naloxone
FDA Approves Abuse-Deterrent Oxycodone/Naloxone Combo
Source: Medscape NeurologyHeadlines [2014.07.23]
The FDA has approved an abuse-deterrent extended-release formulation of oxycodone (Targiniq ER, Purdue Pharma LP), a combination of oxycodone hydrochloride and naloxone hydrochloride.
FDA Approvals
Suboxone Maker Pulls Pills in Favor of Film
Source: MedPage Today Product Alert [2012.09.25]
The buprenorphine-naloxone combination product (Suboxone) in sublingual tablet form will soon be pulled from the U.S. market because its child-resistant packaging isn't effective enough.
Published Studies Related to Naloxone
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.
A prospective, randomized, multicenter acceptability and safety study of direct buprenorphine/naloxone induction in heroin-dependent individuals. [2011.07.12]
Aims To provide controlled data on direct induction with buprenorphine/naloxone (BNX) versus indirect buprenorphine (BPN)-to-BNX induction. Design Phase 4, prospective, randomized, active-drug controlled, parallel-group trial consisting of a 2-day, double-blind, double-dummy induction phase followed by 26 days of open-label treatment with BNX...
Benefit effect of naloxone in benzodiazepines intoxication: findings of a preliminary study. [2011.07]
BACKGROUND: Naloxone, as a low-priced and available drug, may be useful in improvement of signs and symptoms of benzodiazepines intoxication. The aim of this study was assessment of its effect on benzodiazepines poisoning... CONCLUSION: Findings of the study showed that naloxone is effective in management of benzodiazepines poisoning. However, future clinical trials with greater sample size are recommended.
Naloxone as part of a prolonged release oxycodone/naloxone combination reduces oxycodone-induced slowing of gastrointestinal transit in healthy volunteers. [2011.04]
OBJECTIVES: This exploratory study in healthy volunteers investigated the effect of single doses of oxycodone on gastrointestinal (GI) transit time and the degree to which a single dose of naloxone reverses the oxycodone-induced effect... CONCLUSION: A single dose of oxycodone 20 mg significantly prolonged GI transit time but this effect was reduced by co-administration of naloxone.
Clinical Trials Related to Naloxone
Subjective Analgesic Effects of Naloxone and Virtual Reality [Not yet 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.
Safety and Tolerability of Buprenorphine/Naloxone Film Strips [Active, not recruiting]
This study will evaluate the safety and tolerability on the oral mucosa of
buprenorphine/naloxone film strips administered either sublingually or buccally daily for 12
weeks in opioid dependent individuals who are already on a stable regimen of
buprenorphine/naloxone.
A Study to Evaluate the Pharmacokinetic Effect of SCH 503034 (Boceprevir) on Methadone or Buprenorphine/Naloxone Plasma Concentrations (P08123 AM3) [Recruiting]
In this study, participants on methadone or buprenorphine/naloxone maintenance therapy will
be given boceprevir. Blood samples will be taken at specified intervals to find out whether
boceprevir affects the pharmacokinetics of methadone or buprenorphine/naloxone.
Optimal Dose of Prophylactic Naloxone in Reducing Opioid-Induced Side Effects in Children/Adolescents [Recruiting]
This is an investigator initiated dose finding study designed to determine the optimal dose
of naloxone to prevent or minimize the most common side effects induced by opioids, namely
itching, nausea, and vomiting. Male and female inpatients of the Children’s Center of the
Johns Hopkins Hospital, who are greater than 6 and less than 18 years of age with acute,
moderate to severe pain, and who are to be treated with IVPCA morphine will be eligible for
inclusion in this study. Patients will be recruited by a study investigator prior to the
initiation of IVPCA therapy. The majority of patients will be post operative patients, and
will start therapy and the investigational drug in the Post Anesthesia Care Unit or the
Pediatric Intensive Care Unit. We plan on studying between 10 and 99, male and female
patients over a 2 year period.
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.
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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