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Opioid Antagonist clinical trials

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NCT ID: NCT04764630 Completed - Healthy Subjects Clinical Trials

Clinical Study to Investigate the Pharmacokinetics of Multiple Repeated Doses of Intranasal Naloxone

Start date: March 1, 2021
Phase: Phase 1
Study type: Interventional

Intranasal (IN) naloxone is available as 2 mg or 4 mg dose with the indication to re-administer additional doses every 2 to 3 minutes (using alternating nostrils) if needed until emergency medical assistance arrives. The 4 mg dose is distributed in packages of two nasal sprays (1 dose per nasal spray), but additional doses can be administered if needed and available. While the pharmacokinetics of IN naloxone have been determined following administration of a 4 mg dose in each nostril concurrently, the pharmacokinetics have not been determined following multiple doses when there is a 2-3 minute delay between doses and when doses are re-administered to the same nostril. Obtaining data with repeat dosing will inform if and how fast naloxone plasma concentrations can be reached to be able to reverse highly-potent opioid overdoses. This study will be a randomized, unblinded, three-way crossover study to determine naloxone plasma concentration after administration of multiple doses: A. Four 4 mg IN naloxone doses (1 dose every 2.5 minutes) B. Four 4 mg IN naloxone doses (2 doses every 2.5 minutes) C. Two 4 mg IN naloxone doses (1 dose every 2.5 minutes)

NCT ID: NCT03430180 Enrolling by invitation - Clinical trials for Pathological Gambling

Effects of Intranasal Naloxone on Gambling Urges and Craving in Gambling Disorder

NalGamb
Start date: February 22, 2018
Phase: Phase 2
Study type: Interventional

Primary objective: *To determine whether treatment with naloxone hydrochloride nasal spray reduces gambling urge symptoms in patients with gambling disorder The secondary objectives of the study are: - To determine the effects of naloxone hydrochloride nasal spray on gambling severity, frequency and time, internet use, self-efficacy, quality of life, alcohol consumption, depression - To evaluate the safety of naloxone hydrochloride nasal spray in the treatment of gambling disorder

NCT ID: NCT03280966 Not yet recruiting - Clinical trials for Pathological Gambling

Effects of Intranasal Naloxone on Gambling Urges in Gambling Disorder

NalGamb
Start date: November 30, 2017
Phase: Phase 2
Study type: Interventional

Primary objective: *To determine whether treatment with naloxone hydrochloride nasal spray reduces gambling urge symptoms in patients with gambling disorder The secondary objectives of the study are: - To determine the effects of naloxone hydrochloride nasal spray on gambling severity, frequency and time, internet use, self-efficacy, quality of life, alcohol consumption, depression - To evaluate the safety of naloxone hydrochloride nasal spray in the treatment of gambling disorder

NCT ID: NCT01935206 Completed - Pain Clinical Trials

Effect of High Dose Naloxone on Secondary Hyperalgesia

Start date: June 2013
Phase: Phase 1
Study type: Interventional

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.