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Naloxone hydrochloride dihydrate, also known simply as naloxone, is a chemically synthesised substance classified as an opioid antagonist (ATC code V03AB15).[1] It is a synthetic congener of oxymorphone, differing from oxymorphone in that the methyl group on the nitrogen atom is replaced by an allyl group.[4] Naloxone is authorised as a medicine, with authorisation records including XI PL25215/0012 and NO 06-4660.[2] The substance appears in the trial records under product names such as Naloxone 400 micrograms/ml solution for injection/infusion, ZIMHI™ (naloxone hydrochloride injection) for intramuscular or subcutaneous use, NARCAN® (naloxone hydrochloride) nasal spray, and Naloxon B. Braun 0,4 mg/ml injeksjons-/infusjonsvæske, oppløsning.[1][2][3]
Naloxone prevents or reverses the effects of opioids including respiratory depression, sedation and hypotension.[4] It can also reverse the psychotomimetic and dysphoric effects of agonist-antagonists such as pentazocine.[4] Naloxone is an essentially pure opioid antagonist, meaning it does not possess the agonistic or morphine-like properties characteristic of other opioid antagonists.[4] When administered in usual doses and in the absence of opioids or agonistic effects of other opioid antagonists, it exhibits essentially no pharmacologic activity.[4] Naloxone has not been shown to produce tolerance or cause physical or psychological dependence.[4] In the presence of physical dependence on opioids, naloxone will produce withdrawal symptoms.[4]
The clinical trials listed here involve healthy volunteers rather than patients with a diagnosed condition. The therapeutic areas recorded for the substance include physiological processes, anaesthesia and analgesia, and respiratory tract diseases.[1] The conditions studied or relevant to the trials are:
Naloxone hydrochloride dihydrate is available as a solution for injection or infusion, as an injection, and as a nasal spray.[1] The routes of administration recorded in the trial data are intravenous injection, intramuscular use, intravenous infusion, nasal spray, and intravenous.[1] In the trials listed here, naloxone was given intravenously, intramuscularly, and as a nasal spray.[1][2][3]
Three completed clinical trials are listed, all in healthy volunteers. The trials are interventional studies, meaning participants received the substance as part of the study. The table below summarises the trials.
One trial investigated the effect of a pain killer on breathing and another drug that stimulates breathing, using fentanyl to induce respiratory depression.[1] Another trial compared multiple doses of intramuscular versus intranasal naloxone for reversal of opioid toxicity.[2] A third trial studied experimental hypothermia using cold ambient temperature and drug-induced inhibition of shivering.[3]
Two of the trials are Phase 2 studies, and one is classified as a low intervention trial.[1][2][3] All three trials are completed.[1][2][3]
The primary outcome in the first trial was minute ventilation, a measure of how much air a person breathes in one minute.[1] The second trial measured the number of naloxone administrations needed to restore ventilation to baseline levels.[2] The third trial measured temperature at termination, with the experiment ending if temperature reached 35°C or active cooling exceeded three hours.[3]
All three trials enrolled healthy volunteers. The first trial enrolled 18 participants, the second enrolled 22 participants, and the third enrolled 16 participants.[1][2][3]
In the presence of physical dependence on opioids, naloxone will produce withdrawal symptoms.[4] Naloxone has not been shown to produce tolerance or cause physical or psychological dependence.[4] The product information states that naloxone can reverse the psychotomimetic and dysphoric effects of agonist-antagonists.[4]
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